NCT07541014 · Columbia University
TeleheartCR vs. Clinic-Based Cardiac Rehabilitation After Acute Coronary Syndrome
What this study is about
Cardiac rehabilitation (CR) is an effective evidence-based intervention that improves outcomes in patients with acute coronary syndrome (ACS), but many eligible patients do not complete the program.
View original scientific description
Cardiac rehabilitation (CR) is an effective evidence-based intervention that improves outcomes in patients with acute coronary syndrome (ACS), but many eligible patients do not complete the program. A hybrid CR intervention that combines telehealth, home-based, and clinic-based components (TeleheartCR) may increase participation by addressing barriers to access while maintaining the functional capacity benefits of traditional CR. The purpose of this study is to conduct a randomized controlled trial comparing TeleheartCR with traditional clinic-based CR in patients with ACS to evaluate differences in program adherence and pre-to-post program change in functional capacity.
Interventions
BEHAVIORAL
Telehealth-enhanced Hybrid CR
The telehealth-enhanced hybrid cardiac rehabilitation program combines in-person, clinic-based sessions with virtual, home-based sessions. Home-based sessions are delivered via synchronous video visits, with supervision by trained staff and real-time monitoring of physiological data (e.g., heart rate and blood pressure). The program delivers standard components of cardiac rehabilitation, including aerobic and resistance exercise training and patient education on heart-healthy lifestyle behaviors and risk factor management. Participants receive structured, program-specific orientation and training early in the program to support safe participation in virtual home-based sessions. The intervention is digitally enabled and incorporates an integrated system designed to guide and structure participation in program activities. The program includes up to 36 sessions, including a combination of clinic-based and home-based sessions.
BEHAVIORAL
Traditional Cardiac Rehabilitation
The traditional cardiac rehabilitation program is delivered in person through clinic-based sessions according to standard-of-care protocols. Sessions are supervised by trained staff and include aerobic and resistance exercise training, as well as patient education and counseling on heart-healthy lifestyle behaviors and risk factor management. The program includes up to 36 clinic-based sessions delivered according to standard-of-care practice.
Primary outcome measures
Proportion of targeted sessions completed (Program Adherence)
Time frame: During the cardiac rehabilitation program (up to 6 months)
Defined as the proportion of targeted cardiac rehabilitation (CR) sessions completed in each arm. Adherence will be calculated as the number of completed CR sessions divided by 36 (range: 0 to 1).
Change in 6-Minute Walk Test Distance
Time frame: Baseline and end of program (up to 6 months)
Functional capacity will be assessed using the 6-minute walk test (6MWT), which measures the total distance walked in meters over six minutes. Change in functional capacity will be calculated as the difference between post-program and baseline 6MWT distance.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 years or older
- Diagnosis of acute coronary syndrome within the past 12 months
- Eligible for outpatient cardiac rehabilitation
- Able to read and speak English or Spanish
- Resides in New York State
Exclusion criteria
- Severe medical or psychiatric comorbidities that would prevent safe or adequate participation
- High risk for adverse exercise-related cardiovascular events
- Initiation of cardiac rehabilitation prior to enrollment (i.e., \>1 session completed)
- Conditions that would interfere with safe or consistent participation in study procedures
- Home environment or willingness not compatible with safe or adequate participation
- Not expected to be available for follow-up during the study period
- Current participation in another interventional clinical trial that may affect study outcomes
Where
- New York, New York
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations