Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-02 @ 9:32 PM
Study NCT ID:
NCT00507156
Status:
COMPLETED
Last Update Posted:
2016-10-06
First Post:
2007-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postconditioning in the Treatment of Acute ST-segment Elevation Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-05', 'studyFirstSubmitDate': '2007-07-23', 'studyFirstSubmitQcDate': '2007-07-23', 'lastUpdatePostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Final infarct size evaluated by MR', 'timeFrame': '3 month'}], 'secondaryOutcomes': [{'measure': 'MACE (death, re-infarction, TLR)', 'timeFrame': '1, 15 month'}, {'measure': 'Stent thrombosis', 'timeFrame': '15 month'}]}, 'conditionsModule': {'conditions': ['ST-segment Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '21146662', 'type': 'DERIVED', 'citation': 'Lonborg J, Holmvang L, Kelbaek H, Vejlstrup N, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Treiman M, Jensen JS, Engstrom T. ST-Segment resolution and clinical outcome with ischemic postconditioning and comparison to magnetic resonance. Am Heart J. 2010 Dec;160(6):1085-91. doi: 10.1016/j.ahj.2010.09.026.'}, {'pmid': '20118154', 'type': 'DERIVED', 'citation': 'Lonborg J, Kelbaek H, Vejlstrup N, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Holmvang L, Treiman M, Jensen JS, Engstrom T. Cardioprotective effects of ischemic postconditioning in patients treated with primary percutaneous coronary intervention, evaluated by magnetic resonance. Circ Cardiovasc Interv. 2010 Feb 1;3(1):34-41. doi: 10.1161/CIRCINTERVENTIONS.109.905521. Epub 2010 Jan 26.'}]}, 'descriptionModule': {'briefSummary': 'Standard treatment of patients with acute ST-segment elevation myocardial infarction consist of acute re-opening of the occluded coronary artery (primary PCI). Despite successful treatment of the epicardial vessel reperfusion is sometimes inadequate leading to large final infarct sizes. This phenomenon is known as the reperfusion injury. Several animal studies have indicated that graded re-opening of the artery may limit tissue damage. Generally this is referred to as mechanical postconditioning.\n\nThe study investigates the effect on final infarct size evaluated by magnetic resonance scan of postconditioning of ST-segment elevation myocardial infarctions. Mechanical postconditioning is performed by means of several balloon inflations in the injured vessel following its acute re-opening.', 'detailedDescription': 'Please see above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients more than 18 years\n* STEMI \\< 12 hours\n* TIMI 0-1 in infarct related artery\n\nExclusion Criteria:\n\n* Multivessel disease (stenoses in non-infarct related arteries \\>70%)\n* Cardiogenic shock\n* Left main occlusions\n* Lesions that cannot be treated with stents\n* Previous CABG\n* Pregnancy\n* Severe renal insufficiency\n* Previous extensive Q-wave infarction\n* LBBB'}, 'identificationModule': {'nctId': 'NCT00507156', 'acronym': 'POSTCON', 'briefTitle': 'Postconditioning in the Treatment of Acute ST-segment Elevation Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Postconditioning Used to Limit Final Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': 'KF 01 326257'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mek postcon', 'description': 'Re-opening of the infarcted coronary artery by several balloon inflations separated by reperfusion of the vessel.', 'interventionNames': ['Procedure: Mechanical postconditioning']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment', 'description': 'Standard treatment (primary PCI)', 'interventionNames': ['Procedure: Standard primary PCI']}], 'interventions': [{'name': 'Standard primary PCI', 'type': 'PROCEDURE', 'description': 'Acute re-opening of the occluded coronary artery', 'armGroupLabels': ['Standard treatment']}, {'name': 'Mechanical postconditioning', 'type': 'PROCEDURE', 'description': 'Mechanical postconditioning with 4 cycles 30/30 sek balloon inflations', 'armGroupLabels': ['Mek postcon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Cardiac Catherization Lab., Heart Center, Rigshospitalet, University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Thomas Engstrom, D.Sci., PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cheif Consultant'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Consultant', 'investigatorFullName': 'Thomas Engstrom', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}