Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-30 @ 11:42 PM
Study NCT ID:
NCT06701032
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2024-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Parameters in People With Atherosclerotic Vascular Disease Referred to a Secondary Prevention and Cardiovascular Rehabilitation Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart 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'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-17', 'studyFirstSubmitDate': '2024-11-20', 'studyFirstSubmitQcDate': '2024-11-20', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in toe pressure measurement', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Results will be measured in mm Hg'}, {'measure': 'Change in the toe-brachial index', 'timeFrame': 'Change from baseline to 12 weeks'}, {'measure': 'Change in the ankle-brachial index', 'timeFrame': 'Change from baseline to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in 6-minute walk test (6MWT)', 'timeFrame': 'Change from Baseline to 12 weeks', 'description': 'Results will be measured in meters'}, {'measure': 'Short Form Health Survey 36 (SF-36)', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Change in quality of life measured using the SF-36 questionnaire. The scores range from 0-100.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiovascular rehabilitation', 'supervised exercise therapy', 'secondary prevention', 'cardiovascular secondary prevention', 'cardiovascular rehabilitation program', 'hemodynamics of lower limbs', 'toe pressure measurement'], 'conditions': ['Peripheral Artery Disease (PAD)', 'Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))', 'Cerebrovascular Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the hemodynamic changes in the forefoot of patients with coronary, cerebrovascular or peripheral atherosclerotic disease referred a 12-week cardiovascular rehabilitation program (PREV program).\n\nAlso, this study will describe the characteristics of patients admitted to the PREV program and their evolutions in terms of favorable, unfavorable outcomes and complications and up to one year after completion of the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any individual aged 18 years and older who has been diagnosed with peripheral artery disease, coronary artery disease, angina, ischemic heart failure, transient ischemic attack or ischemic stroke (non-cardioembolic, non-hemorrhagic);\n* Have been admitted to the PREV program;\n\nExclusion Criteria:\n\n* Being not able to give written informed consent;'}, 'identificationModule': {'nctId': 'NCT06701032', 'briefTitle': 'Hemodynamic Parameters in People With Atherosclerotic Vascular Disease Referred to a Secondary Prevention and Cardiovascular Rehabilitation Program', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Evolution of Hemodynamic Parameters in People With Atherosclerotic Vascular Disease Referred to a Secondary Prevention and Cardiovascular Rehabilitation (PREV) Program: a Prospective Cohort Study.', 'orgStudyIdInfo': {'id': 'CISSSCA-2025-1208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cardiovascular rehabilitation program', 'interventionNames': ['Other: Cardiovascular rehabilitation program']}], 'interventions': [{'name': 'Cardiovascular rehabilitation program', 'type': 'OTHER', 'description': 'The cardiovascular rehabilitation program consists of a 12 weeks supervised exercises therapy (either in person or in tele-care)', 'armGroupLabels': ['Cardiovascular rehabilitation program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G6V 0M4', 'city': 'Lévis', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CLSC de Lévis - Programme PREV du CISSS de Chaudière-Appalaches', 'geoPoint': {'lat': 46.80326, 'lon': -71.17793}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'collaborators': [{'name': 'CISSS de Chaudière-Appalaches', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jérôme Patry', 'investigatorAffiliation': 'Laval University'}}}}