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NCT06829160 · ClinicalTrials.gov registry record · NA
mHealth-CArdiac REhabilitation for INOCA
A NA study of Ischemia, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 1
- Study location
NCT06829160: Recruiting NA study of Ischemia, sponsored by NYU Langone Health.
NCT06829160 is a NA study of Ischemia that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 250 participants, below the 466-participant average among 11 other Ischemia trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06829160, a NA study of Ischemia, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The SAQ measures disease-related health status (functional status and quality of life) and has a four-week recall period. The SAQ generates a summary score (scale 0-100, 100 = full health, 0 = worst health).
Conditions Studied
Interventions
- BEHAVIORAL Communication with exercise therapist
- BEHAVIORAL mHealth-CR
- BEHAVIORAL Wearable activity monitoring device
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2025-03-21 |
| Est. Completion | 2028-02 |
| Phase | NA |
What NCT06829160 shows while recruiting
NCT06829160 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 466-participant average among 11 other Ischemia trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Ischemia appearing as the primary indexed condition, and to 3 interventions - of which Communication with exercise therapist is the first listed.
NCT06829160 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06829160 about?
NCT06829160 is a clinical study titled "mHealth-CArdiac REhabilitation for INOCA". 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 obstructi...
What is the current status of trial NCT06829160?
This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2025-03-21. Estimated completion is 2028-02.
What conditions does trial NCT06829160 study?
This clinical trial studies the following conditions: Ischemia.
What interventions are being tested in trial NCT06829160?
The interventions under investigation include: Communication with exercise therapist (BEHAVIORAL), mHealth-CR (BEHAVIORAL), Wearable activity monitoring device (BEHAVIORAL).
Who is sponsoring clinical trial NCT06829160?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06829160 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06829160's enrollment target sits among peer trials
250 7th of 11 higher than 5 of 11 other Ischemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ischemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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