Acute Coronary Syndrome (ACS)NCT07541014
TeleheartCR vs. Clinic-Based Cardiac Rehabilitation After Acute Coronary Syndrome
A study testing Telehealth-enhanced Hybrid CR and Traditional Cardiac Rehabilitation in people with Acute Coronary Syndrome (ACS) and Myocardial Infarction, run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome (ACS), Myocardial Infarction
- What is being tested?
- Telehealth-enhanced Hybrid CR and Traditional Cardiac Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Andrea T Duran, PhD, 212-342-4491, atd2127@cumc.columbia.edu
Andrea T Duran, PhD
About this study
Official title: Comparing a Novel Telehealth-enabled Hybrid Cardiac Rehabilitation Program to Clinic-based Cardiac Rehabilitation for Improving Patient Engagement and Functional Outcomes After ACS
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.
Read the detailed description
Over 1 million patients are hospitalized annually in the United States for an acute coronary syndrome (ACS; myocardial infarction or unstable angina). Accordingly, CR is recognized as a Class I, Level A recommendation for secondary prevention in ACS survivors. Yet less than a quarter of eligible cardiac patients utilize CR in the US. Even among patients who initiate CR, fewer attend all prescribed CR sessions, with lower rates observed among those with low socioeconomic status (SES), and racial and ethnic minoritized groups. Low and disparate CR adherence harms patients, as evidence suggests a dose-response relationship, such that each additional CR session attended reduces morbidity and mortality. Innovative program designs are needed to deliver sustained, equitable CR participation among ACS patients.
The central hypothesis of this research study is that TeleheartCR will show greater program implementation (better adherence [primary], acceptability, and appropriateness) and will be just as effective (non-inferior pre- to post-intervention change in functional capacity [primary], health-related quality of life, and cardiorespiratory fitness) relative to clinic-based CR. The TeleheartCR program includes up to 36 sessions delivered through a combination of clinic-based and home-based sessions and is typically completed over approximately 12 weeks. To allow for scheduling flexibility and clinical considerations, participants may be allowed up to 6 months post-enrollment to complete the program and outcome assessments. To formally test the hypothesis, the investigator will conduct an adequately powered effectiveness-implementation hybrid type I randomized controlled trial (RCT) comparing the TeleheartCR program vs. clinic-based CR among ACS patients.
Specifically, this study will determine the degree to which the TeleheartCR program improves CR adherence, clinical outcomes (e.g., functional capacity), and equitable cost/access (i.e., across SES, racial, and ethnic groups) relative to clinic-based CR among ACS patients.
- Being tested
- Telehealth-enhanced Hybrid CR, Traditional Cardiac Rehabilitation
- Keywords
- Cardiac Rehabilitation, Hybrid Cardiac Rehabilitation, Virtual Cardiac Rehabilitation, Implementation Science, Adherence, Functional Capacity, Telehealth
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth-enhanced Hybrid CRBehavioural
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.
Traditional Cardiac RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TeleheartCR | Experimental | Participants will receive Telehealth-enhanced Hybrid Cardiac Rehabilitation Program Receives: Behavioral: Telehealth-enhanced Hybrid CR |
| Traditional CR | Active comparator | Participants will receive Traditional Clinic-based Cardiac Rehabilitation Program Receives: Behavioral: Traditional Cardiac Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of targeted sessions completed (Program Adherence)
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).
Measured: During the cardiac rehabilitation program (up to 6 months)
Change in 6-Minute Walk Test Distance
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.
Measured: Baseline and end of program (up to 6 months)
Secondary outcomes (4)
Mean Acceptability of Intervention Measure Score (Program Acceptability)
Acceptability will be assessed using the Acceptability of Intervention Measure (AIM), a 4-item measure rated on a 1-5 Likert scale. The mean score will be calculated (range: 1-5), with higher scores indicating greater acceptability.
Measured: End of program (up to 6 months)
Mean Intervention Appropriateness Measure Score (Program Appropriateness)
Appropriateness will be assessed using the Intervention Appropriateness Measure (IAM), a 4-item measure rated on a 1-5 Likert scale. The mean score will be calculated (range: 1-5), with higher scores indicating greater appropriateness.
Measured: End of program (up to 6 months)
Change in Health-Related Quality of Life Score
Health-related quality of life will be assessed using the Duke Health Profile (DUKE), a 17-item self-report measure. Scores are used to calculate a general health composite score (range: 0 to 100), with higher scores indicating better health-related quality of life. Change will be calculated as the difference between post-program and baseline scores.
Measured: Baseline and end of program (up to 6 months)
Change in METs Achieved During Exercise Testing
Cardiorespiratory fitness will be assessed using a symptom-limited graded exercise treadmill test. Metabolic equivalents (METs) achieved during exercise testing will be derived from test performance. Change will be calculated as the difference between post-program and baseline METs.
Measured: Baseline and end of program (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start19 May 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndrome (ACS)Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to either a telehealth-enhanced hybrid cardiac rehabilitation program (TeleheartCR) or traditional clinic-based cardiac rehabilitation. This is a single-site, two-arm, parallel-group randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Andrea Duran, Columbia University
- Investigators
- Andrea T. Duran, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541014
- Sponsor's protocol ID
- AAAV3946
- Other IDs
- 5R01MD019189-02
- Status last verified
- May 2026
- First submitted
- 15 Apr 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared, including demographic, clinical, and outcome data underlying the results reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing a Novel Telehealth-enabled Hybrid Cardiac Rehabilitation Program to Clinic-based Cardiac Rehabilitation for Improving Patient Engagement and Functional Outcomes After ACS
- ClinicalTrials.gov ID
- NCT07541014
- Acronym / sponsor ID
- AAAV3946
- Keywords
- Cardiac Rehabilitation, Hybrid Cardiac Rehabilitation, Virtual Cardiac Rehabilitation, Implementation Science, Adherence, Functional Capacity, Telehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 19 May 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Over 1 million patients are hospitalized annually in the United States for an acute coronary syndrome (ACS; myocardial infarction or unstable angina). Accordingly, CR is recognized as a Class I, Level A recommendation for secondary prevention in ACS survivors. Yet less than a quarter of eligible cardiac patients utilize CR in the US. Even among patients who initiate CR, fewer attend all prescribed CR sessions, with lower rates observed among those with low socioeconomic status (SES), and racial and ethnic minoritized groups. Low and disparate CR adherence harms patients, as evidence suggests a dose-response relationship, such that each additional CR session attended reduces morbidity and mortality. Innovative program designs are needed to deliver sustained, equitable CR participation among ACS patients.
The central hypothesis of this research study is that TeleheartCR will show greater program implementation (better adherence [primary], acceptability, and appropriateness) and will be just as effective (non-inferior pre- to post-intervention change in functional capacity [primary], health-related quality of life, and cardiorespiratory fitness) relative to clinic-based CR. The TeleheartCR program includes up to 36 sessions delivered through a combination of clinic-based and home-based sessions and is typically completed over approximately 12 weeks. To allow for scheduling flexibility and clinical considerations, participants may be allowed up to 6 months post-enrollment to complete the program and outcome assessments. To formally test the hypothesis, the investigator will conduct an adequately powered effectiveness-implementation hybrid type I randomized controlled trial (RCT) comparing the TeleheartCR program vs. clinic-based CR among ACS patients.
Specifically, this study will determine the degree to which the TeleheartCR program improves CR adherence, clinical outcomes (e.g., functional capacity), and equitable cost/access (i.e., across SES, racial, and ethnic groups) relative to clinic-based CR among ACS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to either a telehealth-enhanced hybrid cardiac rehabilitation program (TeleheartCR) or traditional clinic-based cardiac rehabilitation. This is a single-site, two-arm, parallel-group randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| TeleheartCR | Experimental | Behavioral: Telehealth-enhanced Hybrid CRParticipants will receive Telehealth-enhanced Hybrid Cardiac Rehabilitation Program |
| Traditional CR | Active comparator | Behavioral: Traditional Cardiac RehabilitationParticipants will receive Traditional Clinic-based Cardiac Rehabilitation Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth-enhanced Hybrid CRThe 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. | Behavioural | TeleheartCR |
| Traditional Cardiac RehabilitationThe 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. | Behavioural | Traditional CR |
Primary outcome
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.
4 secondary outcomes
Mean Acceptability of Intervention Measure Score (Program Acceptability)
Time frame: End of program (up to 6 months)
Mean Intervention Appropriateness Measure Score (Program Appropriateness)
Time frame: End of program (up to 6 months)
Change in Health-Related Quality of Life Score
Time frame: Baseline and end of program (up to 6 months)
Change in METs Achieved During Exercise Testing
Time frame: Baseline and end of program (up to 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared, including demographic, clinical, and outcome data underlying the results reported in publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea T. Duran, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth-enhanced Hybrid CR and Traditional Cardiac Rehabilitation in people with Acute Coronary Syndrome (ACS) and Myocardial Infarction, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea T Duran, PhD (212-342-4491, atd2127@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of targeted sessions completed (Program Adherence) (time frame: During the cardiac rehabilitation program (up to 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.