Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-02-04 @ 1:01 AM
Study NCT ID:
NCT02769650
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2016-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stress-MRI Assessment After Right Coronary Artery CTO Recanalization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-15', 'studyFirstSubmitDate': '2016-05-08', 'studyFirstSubmitQcDate': '2016-05-08', 'lastUpdatePostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress-MRI evaluation', 'timeFrame': 'Within 2 and 12 month after hospitalization', 'description': 'High risk of myocardium ischemia according to stress-MRI data (perfusion defect in 2 or more segments in the area of interest)'}], 'secondaryOutcomes': [{'measure': 'Clinical assessment', 'timeFrame': 'Within 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 moths after hospitalization', 'description': 'Dynamical assessment of stable angina FC (CCS) and dyspnea FC (NYHA)'}, {'measure': 'Stress-MRI evaluation (2)', 'timeFrame': 'Within 2 and 12 month after hospitalization', 'description': 'Dynamics of perfusion in myocardium scar tissue according to stress-MRI data'}, {'measure': 'Major adverse cardiac and cerebrovascular events (MACCE)', 'timeFrame': 'During 1 year after first stress-MRI assessment', 'description': 'Major adverse cardiac and cerebrovascular events (MACCE) including: All-cause mortality, Myocardial infarction, Stroke, Stent thrombosis, Clinically indicated Target lesion revascularization, Any target lesion revascularization, Any target vessel revascularization.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary stenosis', 'Drug-eluting stent', 'Coronary angioplasty with stenting', 'Ischemic Heart Disease', 'Chronic total occlusion', 'Right coronary artery', 'Stress-MRI'], 'conditions': ['Ischemic Heart Disease', 'Coronary Atherosclerosis', 'Coronary Artery Disease', 'Coronary Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that Stress-MRI is a clinically significant method of myocardial perfusion assessment after coronary angioplasty with stenting of right coronary artery (RCA) chronic total occlusion (CTO) is performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable angina, CCS FC II-IV\n* "Right-dominance" coronary circulation according to coronary angiography\n* Absence of other significant atherosclerotic coronary lesions (more than 65%)\n* High risk of myocardium ischemia according to stress-MRI data (perfusion defect in 2 or more segments in the area of interest)\n* Signed, documented informed consent prior to admission to the study\n\nExclusion Criteria:\n\n* Acute coronary syndrome\n* Contraindications for adenosine stress test\n* Low and moderate risk of myocardium ischemia according to stress-MRI data (perfusion defect in less than 2 segments in the area of interest)'}, 'identificationModule': {'nctId': 'NCT02769650', 'briefTitle': 'Stress-MRI Assessment After Right Coronary Artery CTO Recanalization', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'Clinical Significance of Stress-MRI Evaluation of Right Coronary Artery Chronic Total Occlusion Recanalization Efficacy in Patients With Coronary Artery Disease.', 'orgStudyIdInfo': {'id': 'Stress-MRI 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stress-MRI + Chronic total occlusion PCI', 'description': 'Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Coronary angioplasty with stenting of RCA CTO', 'interventionNames': ['Procedure: CTO coronary angioplasty', 'Procedure: Stress-MRI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stress-MRI + Optimal medicamentous treatment', 'description': 'Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Optimal medicamentous treatment', 'interventionNames': ['Drug: Optimal medicamentous treatment', 'Procedure: Stress-MRI']}], 'interventions': [{'name': 'CTO coronary angioplasty', 'type': 'PROCEDURE', 'description': 'A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Recanalisation of coronary artery CTO is performed by the hydrophilic coronary wire, using the most appropriate technique. Then balloon angioplasty of target lesion is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.', 'armGroupLabels': ['Stress-MRI + Chronic total occlusion PCI']}, {'name': 'Optimal medicamentous treatment', 'type': 'DRUG', 'armGroupLabels': ['Stress-MRI + Optimal medicamentous treatment']}, {'name': 'Stress-MRI', 'type': 'PROCEDURE', 'description': 'A standard stress-MRI test with adenosine', 'armGroupLabels': ['Stress-MRI + Chronic total occlusion PCI', 'Stress-MRI + Optimal medicamentous treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630055', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'State Research Institute of CIrculation Pathology', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}