Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-30 @ 5:43 AM
Study NCT ID:
NCT03158532
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2017-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robertoleo@hotmail.com', 'phone': '55 48 999099790', 'title': 'Roberto Léo da Silva', 'organization': 'ISCS'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days', 'description': 'Hand isquemia', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo I/Placebo II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.', 'otherNumAtRisk': 510, 'deathsNumAtRisk': 510, 'otherNumAffected': 6, 'seriousNumAtRisk': 510, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nitroglycerin I/Placebo II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.', 'otherNumAtRisk': 510, 'deathsNumAtRisk': 510, 'otherNumAffected': 12, 'seriousNumAtRisk': 510, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo I /Nitroglycerin II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.', 'otherNumAtRisk': 510, 'deathsNumAtRisk': 510, 'otherNumAffected': 6, 'seriousNumAtRisk': 510, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Nitroglycerin I /Nitroglycerin II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.', 'otherNumAtRisk': 510, 'deathsNumAtRisk': 510, 'otherNumAffected': 13, 'seriousNumAtRisk': 510, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 510, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 510, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1.8'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Radial Artery Occlusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '510', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo I/Placebo II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG001', 'title': 'Nitroglycerin I/Placebo II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG002', 'title': 'Placebo I /Nitroglycerin II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG003', 'title': 'Nitroglycerin I /Nitroglycerin II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 to 24 hours after procedure', 'description': 'Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Late Radial Artery Occlusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '510', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo I/Placebo II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG001', 'title': 'Nitroglycerin I/Placebo II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG002', 'title': 'Placebo I /Nitroglycerin II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG003', 'title': 'Nitroglycerin I /Nitroglycerin II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days after procedure', 'description': 'Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '510', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo I/Placebo II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG001', 'title': 'Nitroglycerin I/Placebo II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG002', 'title': 'Placebo I /Nitroglycerin II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG003', 'title': 'Nitroglycerin I /Nitroglycerin II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '.42', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '.37', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '.42', 'groupId': 'OG002'}, {'value': '2.4', 'spread': '.37', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 24 hours after procedure', 'description': 'Pain felt by the patient in the forearm, assessed using numeric pain rating scale ranging from 0 to 10, 0 best (no pain) 10 worst (unbearable pain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Spasm (Operator Evaluation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '510', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo I/Placebo II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG001', 'title': 'Nitroglycerin I/Placebo II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG002', 'title': 'Placebo I /Nitroglycerin II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG003', 'title': 'Nitroglycerin I /Nitroglycerin II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the realization of the procedure', 'description': 'Catheter friction, as experienced by the operator (subjective measure), during the realization of the procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedure Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '510', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo I/Placebo II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG001', 'title': 'Nitroglycerin I/Placebo II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG002', 'title': 'Placebo I /Nitroglycerin II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG003', 'title': 'Nitroglycerin I /Nitroglycerin II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}], 'classes': [{'categories': [{'measurements': [{'value': '1,193.22', 'spread': '1,105.82', 'groupId': 'OG000'}, {'value': '1,216.29', 'spread': '1,179.52', 'groupId': 'OG001'}, {'value': '1,229.83', 'spread': '1,208.30', 'groupId': 'OG002'}, {'value': '1,179.67', 'spread': '1,073.80', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of the procedure', 'description': 'Total duration of the procedure in seconds, from puncture to haemostatic dressing.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Radiation Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '510', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo I/Placebo II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG001', 'title': 'Nitroglycerin I/Placebo II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG002', 'title': 'Placebo I /Nitroglycerin II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'OG003', 'title': 'Nitroglycerin I /Nitroglycerin II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}], 'classes': [{'categories': [{'measurements': [{'value': '584.52', 'spread': '497.54', 'groupId': 'OG000'}, {'value': '591.30', 'spread': '524.38', 'groupId': 'OG001'}, {'value': '599.78', 'spread': '559.61', 'groupId': 'OG002'}, {'value': '576.09', 'spread': '457.49', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the procedure', 'description': 'Total radiation used in the procedure', 'unitOfMeasure': 'mGy', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo I/Placebo II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'FG001', 'title': 'Nitroglycerin I/Placebo II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'FG002', 'title': 'Placebo I /Nitroglycerin II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'FG003', 'title': 'Nitroglycerin I /Nitroglycerin II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '510'}, {'groupId': 'FG001', 'numSubjects': '510'}, {'groupId': 'FG002', 'numSubjects': '510'}, {'groupId': 'FG003', 'numSubjects': '510'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '510'}, {'groupId': 'FG001', 'numSubjects': '510'}, {'groupId': 'FG002', 'numSubjects': '510'}, {'groupId': 'FG003', 'numSubjects': '510'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'BG000'}, {'value': '510', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}, {'value': '510', 'groupId': 'BG003'}, {'value': '2040', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo I/Placebo II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'BG001', 'title': 'Nitroglycerin I/Placebo II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nPlacebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'BG002', 'title': 'Placebo I /Nitroglycerin II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nPlacebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'BG003', 'title': 'Nitroglycerin I /Nitroglycerin II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).\n\nNitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.\n\nNitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'BG000'}, {'value': '510', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}, {'value': '510', 'groupId': 'BG003'}, {'value': '2040', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '61.52', 'spread': '10.35', 'groupId': 'BG000'}, {'value': '62.06', 'spread': '10.29', 'groupId': 'BG001'}, {'value': '61.52', 'spread': '10.35', 'groupId': 'BG002'}, {'value': '62.06', 'spread': '10.29', 'groupId': 'BG003'}, {'value': '61.79', 'spread': '10.32', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'BG000'}, {'value': '510', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}, {'value': '510', 'groupId': 'BG003'}, {'value': '2040', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}, {'value': '188', 'groupId': 'BG003'}, {'value': '774', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '322', 'groupId': 'BG000'}, {'value': '311', 'groupId': 'BG001'}, {'value': '311', 'groupId': 'BG002'}, {'value': '322', 'groupId': 'BG003'}, {'value': '1266', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-04', 'size': 233162, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-04T13:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2040}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2017-05-16', 'resultsFirstSubmitDate': '2022-03-28', 'studyFirstSubmitQcDate': '2017-05-16', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-04', 'studyFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radial Artery Occlusion', 'timeFrame': '2 to 24 hours after procedure', 'description': 'Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound'}], 'secondaryOutcomes': [{'measure': 'Late Radial Artery Occlusion', 'timeFrame': '30 days after procedure', 'description': 'Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound'}, {'measure': 'Pain Assessment', 'timeFrame': 'up to 24 hours after procedure', 'description': 'Pain felt by the patient in the forearm, assessed using numeric pain rating scale ranging from 0 to 10, 0 best (no pain) 10 worst (unbearable pain)'}, {'measure': 'Spasm (Operator Evaluation)', 'timeFrame': 'During the realization of the procedure', 'description': 'Catheter friction, as experienced by the operator (subjective measure), during the realization of the procedure'}, {'measure': 'Procedure Duration', 'timeFrame': 'Duration of the procedure', 'description': 'Total duration of the procedure in seconds, from puncture to haemostatic dressing.'}, {'measure': 'Radiation Exposure', 'timeFrame': 'During the procedure', 'description': 'Total radiation used in the procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Injury of Radial Artery']}, 'descriptionModule': {'briefSummary': 'The radial approach for a coronary angiography has became popular in several centers because of its simplicity and fewer complications. The radial artery occlusion (RAO) is the main inconvenient and impose a limitation of future use of the radial artery as an access site for catheterization in the future. Several strategies have been used to decrease the incidence of RAO (heparin, patent hemostasis, etc). Nitrates in intra-arterial have been widely studied in prevention of this spasm. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of RAO. The hypothesis that use of nitroglycerin at the start of catheterization would have the same effect was not tested.', 'detailedDescription': 'Transradial access (TRA) has been increasingly adopted for diagnostic and interventional cardiovascular procedures in many centers worldwide. This is largely driven by the evidence supporting an unequivocal reduction in access site-related complications associated with TRA compared with transfemoral access, as well as reduction in cost and increased patient comfort. The radial artery occlusion (RAO) is the main inconvenient and impose a limitation of future use of the radial artery as an access site for catheterization in the future. RAO is the most commun complication of transradial access, and its incidence continues to reach up to 12%.\n\nNitrates in intra-arterial have been widely studied in prevention of this spasm. Nitroglycerin binds to the surface of endothelial cells and undergoes two chemical reductions to form nitric oxide (NO). The nitric oxide then moves out of the endothelial cell and into an adjacent smooth muscle cell, where it promotes the formation of cyclic guanosine monophosphate (cGMP), which then promotes muscle relaxation. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of radial artery occlusion.\n\nA big sheath to artery size ratio could reduce the incidence of RAO, so the main objective of this study is to evaluate whether administration of nitroglycerin at the start of a transradial procedure may preserve the patency of the radial artery; as well, confirm if nitroglycerin administration just before sheet removal helps to keep the radial artery patency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for cardiac catheterization;\n* Suitable candidates for transradial approach;\n* Use of 5 or 6 French sheath in the procedure;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Unable to tolerate nitrates or known allergy to nitrates;\n* Use of any nitrate, by any route of administration, up to 1 hour before the procedure;\n* ST-segment elevation acute myocardial infarction patients during the first 12 hours of sympton onset;\n* Intubated patients (on mechanical ventilation);\n* Complications before or during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke);\n* Prior inclusion in this trial.'}, 'identificationModule': {'nctId': 'NCT03158532', 'acronym': 'Patens', 'briefTitle': 'Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Cardiologia de Santa Catarina'}, 'officialTitle': 'Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin', 'orgStudyIdInfo': {'id': 'Nitroglycerin on Occlusion'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo I/Placebo II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).', 'interventionNames': ['Drug: Placebo I', 'Drug: Placebo II']}, {'type': 'EXPERIMENTAL', 'label': 'Nitroglycerin I/Placebo II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).', 'interventionNames': ['Drug: Nitroglycerin I', 'Drug: Placebo II']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo I /Nitroglycerin II', 'description': '0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).', 'interventionNames': ['Drug: Placebo I', 'Drug: Nitroglycerin II']}, {'type': 'EXPERIMENTAL', 'label': 'Nitroglycerin I /Nitroglycerin II', 'description': '500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).', 'interventionNames': ['Drug: Nitroglycerin I', 'Drug: Nitroglycerin II']}], 'interventions': [{'name': 'Nitroglycerin I', 'type': 'DRUG', 'otherNames': ['Tridil'], 'description': '500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.', 'armGroupLabels': ['Nitroglycerin I /Nitroglycerin II', 'Nitroglycerin I/Placebo II']}, {'name': 'Placebo I', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.', 'armGroupLabels': ['Placebo I /Nitroglycerin II', 'Placebo I/Placebo II']}, {'name': 'Nitroglycerin II', 'type': 'DRUG', 'otherNames': ['Tridil'], 'description': '500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.', 'armGroupLabels': ['Nitroglycerin I /Nitroglycerin II', 'Placebo I /Nitroglycerin II']}, {'name': 'Placebo II', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.', 'armGroupLabels': ['Nitroglycerin I/Placebo II', 'Placebo I/Placebo II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88036-800', 'city': 'Florianópolis', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Hospital Universitário Professor Polydoro Ernani de São Thiago', 'geoPoint': {'lat': -27.59667, 'lon': -48.54917}}, {'zip': '88000', 'city': 'São Jose', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Instituto de Cardiologia de Santa Catarina'}, {'zip': '17515-900', 'city': 'Marília', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Irmandade Santa Casa Misericórdia Marília', 'geoPoint': {'lat': -22.21389, 'lon': -49.94583}}], 'overallOfficials': [{'name': 'Roberto L da Silva, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto de Cardiologia de Santa Catarina'}, {'name': 'José R Costa Júnior, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instituto Dante Pazzanese de Cardiologia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Cardiologia de Santa Catarina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Intervencional cardiologist', 'investigatorFullName': 'Roberto Léo da Silva', 'investigatorAffiliation': 'Instituto de Cardiologia de Santa Catarina'}}}}