NCT06829160 mHealth-CArdiac REhabilitation for INOCA
| NCT ID | NCT06829160 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Ischemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2025-03-21 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multi-site phase II, 2:1 pragmatic randomized trial of 250 participants within the NYU Langone Health (NYULH) and Emory University Medical Center system to evaluate mobile health cardiac rehabilitation (mHealth-CR) in patients who meet clinical criteria for INOCA (ischemia and no obstructive coronary disease on imaging). Participants will be randomized to mHealth-CR or usual care. The study intervention takes place for 3 months which is the time period for most traditional CR programs. The overall study goals are threefold: 1) to evaluate whether an mHealth-CR intervention that includes activity tracking, weekly counseling, and exercise documentation, improves health status (i.e., symptoms, function, and quality of life) in patients with INOCA at 3 months; 2) to evaluate effects of the mHealth-CR intervention vs. usual care on physical activity and exercise capacity, general health status, and depressive symptoms (secondary endpoints). We will also evaluate effects on primary and secondary outcomes at 6 months and 1 year; and 3) to characterize engagement and elucidate any factors that limit engagement.
Eligibility Criteria
Inclusion Criteria: * Age 18 and over * Diagnosis of Ischemia with Non-Obstructive Coronary Arteries (INOCA) based on evidence of ischemia and/or ischemic symptoms, plus non-obstructive Coronary artery disease (CAD) on computed tomography (CT) or invasive angiography Exclusion Criteria: * Seattle Angina Questionnaire (SAQ) = 100 * Non-ambulatory * Pregnant * Moderate or severe cognitive impairment * Unable/willing to provide consent * Incarcerated * Unable to use mHealth * Severe osteoarthritis or joint replacement within 3 months * Parkinsons disease or other movement disorders * Regular use of walker * Life expectancy \< 12 months * Clinical judgement concerning other safety or non-adherence issues * Unable to read and communicate in English since the app content is currently only available in English.
Contact & Investigator
Harmony Reynolds, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06829160 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ischemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06829160 currently recruiting?
Yes, NCT06829160 is actively recruiting participants. Contact the research team at INOCA@nyulangone.org for enrollment information.
Where is the NCT06829160 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06829160 clinical trial?
NCT06829160 is sponsored by NYU Langone Health. The principal investigator is Harmony Reynolds, MD at NYU Langone Health. The trial plans to enroll 250 participants.