Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:29 PM
Study NCT ID:
NCT07465692
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Results of Rehabilitation of Patients With Myocardial Infarction After Coronary Artery Stenting. The Register.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1046}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-03-06', 'studyFirstSubmitQcDate': '2026-03-06', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined', 'timeFrame': '20 years', 'description': 'Cardiovascular mortality, non-fatal acute myocardial infarction, non-fatal stroke, need for revascularization'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '20 years'}, {'measure': 'Composite endpoint of major adverse cardiovascular events (MACE)', 'timeFrame': '20 years', 'description': 'Composite endpoint of major adverse cardiovascular events (MACE), defined as the first occurrence of any of the following: recurrent myocardial infarction, ischemic or hemorrhagic stroke, repeat coronary revascularization (PCI or CABG), cardiovascular death.'}, {'measure': 'cardiovascular mortality', 'timeFrame': '20 years'}, {'measure': 'myocardial infarction', 'timeFrame': '20 years'}, {'measure': 'stroke', 'timeFrame': '20 years'}, {'measure': 'need for revascularization', 'timeFrame': '20 years'}, {'measure': 'hospitalization due to cardiovascular complications', 'timeFrame': '20 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myocardial infarction', 'rehabilitation', 'coronary artery stenting'], 'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': "Endovascular intervention is one of the most effective treatment for acute coronary syndrome. Therefore, studying the impact of various medical rehabilitation programs on the course of coronary heart disease, patient quality of life, restenosis, and prognosis is of scientific and practical interest. Medical rehabilitation is a crucial stage in patient care after myocardial revascularization. Regular moderate-intensity physical activity helps improve endothelial function and has anti-inflammatory and antithrombogenic effects. Improving a patient's prognosis after myocardial infarction depends on the duration and intensity of cardiac rehabilitation programs, as well as the patient's motivation. Therefore, this issue requires further study, particularly in patients who have undergone endovascular interventions on coronary arteries.", 'detailedDescription': 'The study was an interventional (clinical) trial, randomized in parallel groups. A total of 1,046 patients were included.\n\nA total of 1,046 patients of both sexes were randomized into two groups. Group 1 (control) patients received standard therapy required for patients undergoing coronary artery stenting during the acute phase of myocardial infarction. They continued their usual physical activity and attended a school for patients with myocardial infarction. Group 2 patients received standard therapy required for patients undergoing coronary artery stenting during the acute phase of myocardial infarction, attended a school for patients with myocardial infarction, and participated in a physical training program. The training program lasted over four months. Postoperatively, patients underwent blood tests, echocardiography, ECG, and bicycle ergometry. The next visit was performed after an average of eight years (with a maximum follow-up period of 11 years). Cardiovascular events were assessed at this stage. Patients who were unable to attend the clinic were interviewed by telephone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute myocardial infarction, coronary artery stenting\n\nExclusion Criteria:\n\n* Age (younger 18 years, older 75 years)'}, 'identificationModule': {'nctId': 'NCT07465692', 'briefTitle': 'Long-term Results of Rehabilitation of Patients With Myocardial Infarction After Coronary Artery Stenting. The Register.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Medical Research Center for Therapy and Preventive Medicine'}, 'officialTitle': 'Long-term Results of Rehabilitation of Patients With Myocardial Infarction After Endovascular Intervention on Coronary Arteries at the Outpatient Stage. Register', 'orgStudyIdInfo': {'id': 'LCRAS07-01/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical training', 'description': 'Integrated Rehabilitation consisting of exercise training and school for patients', 'interventionNames': ['Other: Physical training program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard follow-up and attending school for patients at the participating heart center'}], 'interventions': [{'name': 'Physical training program', 'type': 'OTHER', 'description': 'Integrated Rehabilitation consisting of exercise training for at least 1.5 months', 'armGroupLabels': ['Physical training']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Medical Research Center for Therapy and Preventive Medicine', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}