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:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT04335695
Eligibility Criteria:
Inclusion Criteria:
1. Enrolled in the vascular rehabilitation program at The Heart Hospital Cardiac Rehabilitation Facility.
2. Female or male patients ≥18 years of age.
3. Patient must be accessible for treatment and follow-up.
4. Agrees to wear the activity tracker wrist-worn device
5. Agrees to the follow-up QOL survey schedule
6. Agrees to the follow-up ABI schedule
7. All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.
Exclusion Criteria:
1. Declines participation in the study.
2. Has a life-expectancy less than 18 months.
3. Unable to complete necessary study follow-up procedures.
4. Unwilling to wear the wrist-worn activity tracker device.
5. Women who are pregnant.
6. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:
1. severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
2. home oxygen
3. neurologic or orthopedic conditions limiting ability to appropriately comply with rehabilitation program.
4. class III or class IV NY class congestive heart failure
7. Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04335695
Study Brief:
Protocol Section:
NCT04335695