Mobile health cardiac rehabilitation for patients with ischemia and no obstructive coronary disease
mHealth-CArdiac REhabilitation for INOCA (INOCA-CARE)
This study is testing if a mobile health program that includes activity tracking and counseling can help people with ischemia but no blocked arteries feel better and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06829160 on ClinicalTrials.gov |
What this trial studies
This multi-site pragmatic randomized trial aims to evaluate the effectiveness of a mobile health cardiac rehabilitation (mHealth-CR) program for patients diagnosed with ischemia and no obstructive coronary artery disease (INOCA). A total of 250 participants will be randomized to receive either mHealth-CR, which includes activity tracking, weekly counseling, and exercise documentation, or usual care over a 3-month period. The study will assess improvements in health status, physical activity, exercise capacity, and depressive symptoms among participants. The goal is to determine if mHealth-CR can enhance quality of life and overall health outcomes for this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over diagnosed with ischemia and non-obstructive coronary arteries.
Not a fit: Patients who are non-ambulatory, have severe cognitive impairment, or are unable to use mobile health technology may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the health status and quality of life for patients with INOCA.
How similar studies have performed: Other studies have shown promise in using mobile health interventions for cardiac rehabilitation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Harmony Reynolds, MD — NYU Langone Health
- Study coordinator: Harmony Reynolds, MD
- Email: INOCA@nyulangone.org
- Phone: 212-263-7751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.