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mHealth-CArdiac REhabilitation for INOCA

RecruitingNAAges 18 Years - anyAllNYU Langone Health
NCT06829160 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 h

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📋 Eligibility rules (as published)
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.
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What it tests

  • Communication with exercise therapist
  • mHealth-CR
  • Wearable activity monitoring device
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Where

1 site
NYU Langone Health
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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