Actively Recruiting
mHealth-CArdiac REhabilitation for INOCA
Led by NYU Langone Health · Updated on 2026-04-23
250
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
mHealth-CArdiac REhabilitation for INOCA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Seattle Angina Questionnaire (SAQ) score of 100
- Non-ambulatory status
- Pregnant
- Moderate or severe cognitive impairment
- Unable or unwilling to provide consent
- Incarcerated
- Unable to use mobile health technology
- Severe osteoarthritis or joint replacement within the last 3 months
- Parkinson's disease or other movement disorders
- Regular use of walker
- Life expectancy less than 12 months
- Clinical judgement concerns about safety or adherence
- Unable to read and communicate in English as app content is only available in English
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
H
Harmony Reynolds, MD
CONTACT
J
John Dodson, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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