Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-03-26 @ 10:48 PM
Study NCT ID:
NCT00469950
Status:
COMPLETED
Last Update Posted:
2015-04-14
First Post:
2007-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Training on Endothelial Function, Progression of Disease,Inflammation, Heart Rate Variability and Mental Health After Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-13', 'studyFirstSubmitDate': '2007-05-04', 'studyFirstSubmitQcDate': '2007-05-04', 'lastUpdatePostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Oxygen uptake capacity (mg/kg/min), Sf36 scores', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PCI', 'stent', 'training', 'endothelial function', 'restenosis', 'late luminal loss', 'heart rate variability', 'oxygen uptake capacity', 'inflammatory markers'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '21450602', 'type': 'DERIVED', 'citation': 'Munk PS, Breland UM, Aukrust P, Ueland T, Kvaloy JT, Larsen AI. High intensity interval training reduces systemic inflammation in post-PCI patients. Eur J Cardiovasc Prev Rehabil. 2011 Dec;18(6):850-7. doi: 10.1177/1741826710397600. Epub 2011 Feb 18.'}, {'pmid': '19853690', 'type': 'DERIVED', 'citation': 'Munk PS, Staal EM, Butt N, Isaksen K, Larsen AI. High-intensity interval training may reduce in-stent restenosis following percutaneous coronary intervention with stent implantation A randomized controlled trial evaluating the relationship to endothelial function and inflammation. Am Heart J. 2009 Nov;158(5):734-41. doi: 10.1016/j.ahj.2009.08.021.'}]}, 'descriptionModule': {'briefSummary': 'The Efector study is an open, randomized and controlled trial assessing the effect of regular exercise training on endothelial function, inflammatory markers, progression of disease, heart rate variability and mental health in patients who have been successfully treated with percutaneous coronary intervention and stent implantation for angina pectoris.', 'detailedDescription': 'Pas er randomized to a 6 months training group or none training. At baseline and at 6 months patients are examined with blood tests to measure serum concentrations of inflammatory markers, a test for endothelial function, heart rate variability and a coronary angiogram. Further patients are asked to answer questionnaires concerning mental health (SF36, HADS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Successful PCI with stent implantation,\n* Able to participate in the training program,\n* No planned further revascularisation\n\nExclusion Criteria:\n\n* CAGB,\n* Inflammatory diseases other than CAD,\n* Heart failure,\n* Severe kidney failure,\n* Inability to participate in the training program'}, 'identificationModule': {'nctId': 'NCT00469950', 'acronym': 'EFECTOR', 'briefTitle': 'The Effect of Training on Endothelial Function, Progression of Disease,Inflammation, Heart Rate Variability and Mental Health After Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Helse Stavanger HF'}, 'officialTitle': 'Effect of Exercise Training After Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': '3.2005.1437'}}, 'armsInterventionsModule': {'interventions': [{'name': 'exercise training', 'type': 'BEHAVIORAL', 'description': 'Exercise training in groups'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4022', 'city': 'Stavanger', 'state': 'Rogaland', 'country': 'Norway', 'facility': 'Stavanger University Hospital', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}], 'overallOfficials': [{'name': 'Peter S Munk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helse Stavanger HF'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}