mHealth-CArdiac REhabilitation for INOCA

ConditionIschemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

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

Qualifiers

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

Disqualifiers

Seattle Angina Questionnaire (SAQ) = 100

Non-ambulatory

Pregnant

Moderate or severe cognitive impairment

Trial design

Treatments tested in this trial

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

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators

NYU Langone Health

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator