No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
250 (estimated)
Sponsor
NYU Langone Health · Other
Who this trial is looking for
This trial is looking for participants aged 18 and over who have ischemia without blocked arteries. Participants will use a mobile health program for 3 months to help improve their heart health through activity tracking and support.
Are You a Good Fit for This Trial?
Rules you outParkinson's diseaseOther movement disorders
You may be able to join if
I am 18 years old or older.
I have been diagnosed with ischemia with non-obstructive coronary arteries.
You may not be able to join if
I have a Seattle Angina Questionnaire score of 100.
I am non-ambulatory.
I am pregnant.
I have moderate or severe cognitive impairment.
I cannot give my consent.
I am currently incarcerated.
I cannot use mobile health applications.
I have severe osteoarthritis or had a joint replacement in the last 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 st…
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.
Trial Locations
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City
State
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Status
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…
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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