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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT06915220
Eligibility Criteria:
Inclusion Criteria:
* Must be a patient within the Michigan Medicine clinical system with data available in the electronic health record after January 1, 2020.
* Age \> 18
* Owns and is a daily user of an Android or iPhone smartphone with study supported operating software.
* Understands English to enable informed consent, completion of study-related surveys, and compliance with study notifications.
* Will be completing within 30 days or have completed in the last 30 days the cardiac rehabilitation program at Michigan Medicine based on one of the following indications:
* Coronary artery disease (including acute coronary syndromes and stable angina) following percutaneous coronary intervention (PCI)
* Coronary artery disease following coronary artery bypass surgery (CABG)\]
* Valve repair or replacement (either surgical or percutaneous)
* Coronary artery disease or an acute coronary syndrome not requiring revascularization
Exclusion Criteria:
* Orthopedic or neurological condition limiting ability to actively engage in moderate intensity physical activity (e.g., brisk walking)
* Greater than mild cognitive impairment
* Wrist too large to wear an activity tracker comfortably. This will be assessed by asking participants "If they have ever had difficulty wearing a watch in the past due to the band being too small."
* Currently receiving palliative care and/or in hospice care
* Severe valvular stenosis or regurgitation
* Unrevascularized left main coronary artery disease (\> 50% obstruction on angiography) or proximal left anterior descending disease (\>70% obstruction on angiography).
* Exercise-induced ventricular tachycardia
* Cardiac arrest within the prior 6 months
* New York Heart Association (NYHA) class III or IV heart failure
* Pulmonary arterial hypertension treated with inhaled or intravenous pulmonary hypertension-specific therapy
* Ejection fraction \<40%
* Determined to be unsafe for participation in this program as assessed by a clinical nurse or investigative team.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06915220
Study Brief:
Protocol Section:
NCT06915220