Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT00176358
Status:
UNKNOWN
Last Update Posted:
2007-09-10
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Percutaneous Coronary Angioplasty Compared With Exercise Training in Symptomatic Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'lastUpdateSubmitDate': '2007-09-07', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2007-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['CAD', 'Stable Angina Pectoris']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare coronary angioplasty with stent implantation with an exercise rehabilitation program in patients with stable coronary artery disease (CAD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Angiographically documented CAD, with at least one coronary artery stenosis of more than 50% in a native segment never subjected to intervention, which is recommended for treatment with percutaneous transluminal coronary angioplasty (PTCA).\n* Stable coronary artery disease\n* Eligible patients could be asymptomatic or have class I to III angina (Canadian Cardiovascular Society \\[CCS\\]) with documented myocardial ischemia\n* Angina pectoris threshold \\> 50 Watt (cycle ergometry)\n* Permanent residence should be within 25 km of training facility.\n\nExclusion Criteria:\n\n* \\< 18 or \\> 70 years of age\n* Patient currently participating in an exercise training program\n* Unstable angina pectoris or myocardial infarction during the last 2 weeks\n* Symptoms of CCS class IV\n* Exercise limitations due to clinical conditions not related to CAD\n* Left ventricular ejection fraction (LVEF) of \\< 40%\n* Ventricular arrhythmia (Lown Ivb)\n* Hemodynamically significant valvular heart disease\n* Previous cardiac surgery\n* PTCA performed during the last 12 months\n* Any major non-cardiac condition that would adversely affect survival during the duration of the study\n* Reduced compliance'}, 'identificationModule': {'nctId': 'NCT00176358', 'briefTitle': 'Percutaneous Coronary Angioplasty Compared With Exercise Training in Symptomatic Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'orgStudyIdInfo': {'id': '139/2001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PTCA and Stent Implantation', 'type': 'DEVICE'}, {'name': 'Exercise Training', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04289', 'city': 'Leipzig', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sven Möbius-Winkler, MD', 'role': 'CONTACT', 'phone': '00493418650'}, {'name': 'Sven Möbius-Winkler, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Claudia Walther, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Leipzig - Heart Center', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'centralContacts': [{'name': 'Rainer Hambrecht, Prof.', 'role': 'CONTACT', 'email': 'rhambrecht@medizin.uni-leipzig.de', 'phone': '00493418651426'}], 'overallOfficials': [{'name': 'Rainer Hambrecht, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Center Leipzig - University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}}}}