Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT03646760
Eligibility Criteria:
Inclusion Criteria:
1. Has agreed to participate in CR and has experienced a cardiac event (myocardial infraction, coronary revascularization, heart valve surgery, or cardiac transplant in the past 6 months; diagnosed with chronic, stable AHA/ACC stage B or C heart failure or Canadian class 0-2 stable angina pectoris)
2. Lives in or plans to remain in the greater Detroit, MI area for the next year
3. Age 18-85 years of age
4. Agrees to attend at least one CBCR session
5. Agrees to scheduling at least 2, up to 3, CR sessions (either CBCR or HYCR)/wk
6. Has demonstrated to research staff their ability to access and connect to the internet via smart phone or tablet and already has access to satisfactory home- or community-based exercise equipment
Exclusion Criteria:
1. Received a left ventricular assist device, receiving continuous inotropic support (e.g., milrinone), or undergoing hemodialysis
2. Angina at rest or with a low functional capacity (\< 2 METs)
3. Advanced cancer, advanced risk for falling, limiting cognitive impairment, or other advanced disorder that limits participation in CR
1. Advanced risk for falling will be assessed by 5X sit-to-stand test, with a cut-off score of \>15 seconds
2. Cognitive assessment will be completed using the Mini-Cog instrument, with a cut-off score \< 3 used to exclude potential subjects.
4. Severe arrhythmia unless adequately treated (e.g., implantable cardiac defibrillator)
5. Pregnant or plan to become pregnant in the next year.
6. Major cardiovascular procedure or hospitalization planned in the next 6 months
7. Less than 12 month life expectancy
8. Participation in another clinical trial that interferes with iATTEND participation, follow-up, data collection, exercise capacity or quality of life.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03646760
Study Brief:
Protocol Section:
NCT03646760