Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-28 @ 4:00 PM
Study NCT ID:
NCT01740856
Status:
COMPLETED
Last Update Posted:
2016-04-12
First Post:
2012-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Assess the Safety of Reducing the Time of Bed Rest After Cardiac Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564258', 'term': 'Coronary Artery Disease, Autosomal Dominant, 1'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C092779', 'term': 'RE1-silencing transcription factor'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 730}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-10', 'studyFirstSubmitDate': '2012-10-29', 'studyFirstSubmitQcDate': '2012-11-30', 'lastUpdatePostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'until three days', 'description': 'Bleeding: seen after the femoral compression after walking and after sitting down ;Hematoma, pseudoaneurysm and bruise: at the site of arterial puncture;vaso-vagal reaction. All of these will be monitoring by telephone contact at 24h, 48h and 72 hours.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cardiac catheterization', 'safety', 'nursing care', 'rest', 'Patients'], 'conditions': ['Coronary Artery Disease With Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Reducing the rest time after diagnostic cardiac catheterization for three hours does not increase the complications concerning to the procedure, compared to the rest of five hours.', 'detailedDescription': 'Reducing the rest time after diagnostic cardiac catheterization for three hours does not increase the complications concerning to the procedure, compared to the rest of five hours. The aim of this study is to compare through a randomized clinical trial to reduce the rest time in bed for five hours after elective diagnostic cardiac catheterization, with a 6F sheath with a transfemoral approach, for a period of three hours of the occurrence of bleeding, hematoma, pseudoaneurysm and a vasovagal reaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age equal too or above 18 years\n* patients undergoing elective diagnostic cardiac catheterization on an outpatient basis and\n* who agree to participate by reading and signing the informed consent form.\n\nExclusion Criteria:\n\n* patients with restriction ambulation;\n* users of coumarin anticoagulants;\n* IMC greater than 35 kg/m2;\n* patients with hypertension (systolic PA \\> 180 mmHg and diastolic PA \\> 110 mmHg) at the end of the procedure'}, 'identificationModule': {'nctId': 'NCT01740856', 'acronym': 'Three-Cath', 'briefTitle': 'Clinical Trial to Assess the Safety of Reducing the Time of Bed Rest After Cardiac Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Randomized Clinical Trial to Assess the Safety of Reducing the Time of Bed Rest Within Five to Three Hours After Diagnostic Cardiac Catheterization With a 6F Sheath', 'orgStudyIdInfo': {'id': 'UFRGS and HCPA 100401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rest three hours', 'description': 'Rest three hours', 'interventionNames': ['Other: Rest three hours']}, {'type': 'EXPERIMENTAL', 'label': 'Rest five hours', 'description': 'Rest five hours', 'interventionNames': ['Other: Rest five hours']}], 'interventions': [{'name': 'Rest three hours', 'type': 'OTHER', 'description': 'Intervention group (IG), will maintain bed rest supine for two hours after the digital compression. After this period prescribed, patients sit in bed with the head elevated at 45 degrees for 50 minutes and then walk within the unit hemodynamic for about 10 minutes. Afterwards patients remain sitting out of bed in hemodynamics unit, until they are five hours, then they will be discharge.', 'armGroupLabels': ['Rest three hours']}, {'name': 'Rest five hours', 'type': 'OTHER', 'description': 'Control group (CG) maintain bed rest supine for four hours after the digital compression. After this period, the patients sit in bed with the head elevated at 45 degrees for 50 minutes and then walk into the unit hemodynamic for 10 minutes. After that patients receive discharge.', 'armGroupLabels': ['Rest five hours']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035003', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clinicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Eneida R Rabelo da Silva, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Clinicas de Porto Alegre - Graduate Programa from Nursing School at Federal University of Rio Grande do Sul'}, {'name': 'Roselene Matte, RN, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Clinicas de Porto Alegre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, ScD', 'investigatorFullName': 'Eneida Rejane Rabelo da Silva', 'investigatorAffiliation': 'Hospital de Clinicas de Porto Alegre'}}}}