Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-05 @ 5:41 PM
Study NCT ID:
NCT07095504
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Cardiac Rehabilitation Intervention to Improve Cardiovascular Health and Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cardiovascular health score', 'timeFrame': 'Baseline, 3 Months, 6 Months', 'description': "Cardiovascular health score will be determined by the American Heart Association's (AHA) Life's Simple 8 (LS8). The scale is 0-100 pts (low to high), with LE8 categories as low (0-49), moderate (50-79) and high (80-100). A higher score indicates higher cardiovascular health."}, {'measure': 'Percent of Virtual world-based cardiac rehabilitation attended', 'timeFrame': 'Baseline, 6 Months', 'description': 'Virtual world-based cardiac rehabilitation attended will be determined by the number of sessions prescribed vs the number of sessions attended (reported as a percent).'}], 'secondaryOutcomes': [{'measure': 'Number of cardiovascular hospital readmissions', 'timeFrame': 'Baseline, 6 Months', 'description': 'Cardiovascular Hospital readmissions will be determined by the number of times a patient is admitted to the hospital after initial admission.'}, {'measure': 'All-cause mortality', 'timeFrame': '6 Months', 'description': 'All-cause mortality will be determined by the number of patient deaths no matter the cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Health']}, 'descriptionModule': {'briefSummary': 'A single-group, multi-center, non-randomized clinical trial will be conducted to assess the feasibility of implementing an enhanced virtual world-based cardiac rehabilitation (VWCR) program within a muti-site clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for CR according to Centers for Medicare \\& Medicaid Services (CMS) guidelines (diagnosed within the preceding 12 months) to include one or more of the following:\n\n * Myocardial infarction\n * Coronary artery bypass surgery\n * Current stable angina (chest pain)\n * Heart valve repair or replacement\n * Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting\n * Heart or heart-lung transplant\n * Stable chronic heart failure\n* Receiving care at one of the participating CR centers\n* Age ≥18 years\n* Basic Internet navigation skills\n* Active email address\n* Access to Internet at home or public access (church, library, etc) for 3 virtual visits per week\n\nExclusion Criteria:\n\n* High risk patients according to the AACVPR risk stratification44 given safety concern of unsupervised exercise\n\n * Patients receiving continuous inotropic support\n * Recent receipt of a mechanical support device\n * Presence of hemodynamically unstable dysrhythmias (e.g., ventricular tachycardia)\n * Decompensated heart failure\n * Symptomatic valvular heart disease\n * Uncontrolled angina\n* Pregnancy (due to associated hormonal and weight changes) per patient report\n* Receiving continuous inotropic support\n* Presence of a mechanical circulatory support device\n* Decompensated heart failure\n* Symptomatic valvular heart disease\n* Uncontrolled angina\n* Presence of hemodynamically unstable dysrhythmias (e.g., ventricular tachycardia) given safety concern of unsupervised exercise\n* Visual/hearing impairment or mental disability that would preclude independent use of the VW platform\n* Non-English-speaking patients due to logistical challenges with real time translation over a virtual platform\n* Currently participating in a cardiac rehab program'}, 'identificationModule': {'nctId': 'NCT07095504', 'briefTitle': 'A Study of Cardiac Rehabilitation Intervention to Improve Cardiovascular Health and Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Destination Cardiac Rehab: A Multicenter Feasibility Clinical Trial of an Enhanced Virtual World-based Cardiac Rehabilitation Intervention to Improve Cardiovascular Health and Outcomes Among Cardiac Patients', 'orgStudyIdInfo': {'id': '25-002186'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subject enrolled in a cardiac rehab program', 'interventionNames': ['Behavioral: Virtual World-based Cardiac Rehabilitation (VWCR) program']}], 'interventions': [{'name': 'Virtual World-based Cardiac Rehabilitation (VWCR) program', 'type': 'BEHAVIORAL', 'description': '36 Virtual World-based Cardiac Rehabilitation sessions over the course of 12 weeks (3 sessions/week)', 'armGroupLabels': ['Subject enrolled in a cardiac rehab program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92617', 'city': 'Irvine', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shaista Malik, M.D.', 'role': 'CONTACT', 'email': 'smalik@hs.uci.edu'}, {'name': 'Shaista Malik, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California (UCI), Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jena Hayes', 'role': 'CONTACT', 'email': 'hayes.jena@mayo.edu'}, {'name': 'Bryan Taylor, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'LaPrincess Brewer, M.D., M.P.H.', 'role': 'CONTACT', 'email': 'Brewer.LaPrincess@mayo.edu'}, {'name': 'LaPrincess Brewer, M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Lainey Moen, M.A.', 'role': 'CONTACT', 'email': 'moen.lainey@mayo.edu', 'phone': '507-266-7062'}], 'overallOfficials': [{'name': 'LaPrincess Brewer, M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'LaPrincess C. Brewer', 'investigatorAffiliation': 'Mayo Clinic'}}}}