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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 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.

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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.

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

FieldValue
Enrollment Target 250 participants
Start Date 2025-03-21
Est. Completion 2028-02
Phase NA

Sponsor

NYU Langone Health

1,164 total trials

What the Registry Record Tells You About NCT06829160

The ClinicalTrials.gov registry entry for NCT06829160 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 466-participant average among 11 other Ischemia trials with a reported enrollment target (46% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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