Myocardial InfarctionNCT05933083
MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation
A study testing In-person cardiac rehabilitation and Telehealth cardiac rehabilitation in people with Myocardial Infarction and Heart Failure, Systolic, run by University of California, San Francisco at 5 sites in United States.
Trial summary
Cardiac rehabilitation is a medically recommended program for patients with certain heart conditions. It includes exercise training, health education, and counseling. Unfortunately, many patients do not participate in cardiac rehabilitation. Some find it challenging to attend the in-person sessions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Heart Failure, Systolic, Heart Valve Diseases
- What is being tested?
- In-person cardiac rehabilitation and Telehealth cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Oct 2023to Dec 2028
- 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 or older
- Eligible for cardiac rehabilitation
- Diagnosis within 1 year prior to consent
- Myocardial infarction
- Percutaneous coronary intervention
- Coronary artery bypass
Show all 13Show fewer
- Heart valve repair or replacement
- Heart transplant
- Chronic stable angina, or
- Chronic systolic heart failure (ejection fraction ≤ 35%)
- Referred to cardiac rehabilitation by a doctor or advanced practice provider for another indication that is covered by the participant's insurance, such as heart failure with preserved ejection fraction or aortic surgery.
- Willing to be randomized to in-person or telehealth cardiac rehabilitation
- Able to communicate in English or Spanish
Who cannot join
- Unstable arrhythmias which may make unmonitored exercise unsafe (e.g., history of ventricular tachycardia not on medical therapy and without an implantable cardioverter defibrillator)
- Unsafe for patient to participate in the opinion of the investigator
- Hospice
- Unable to consent for self
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48105
Johns Hopkins University Medical Center
Baltimore, Maryland, 21287
Denver Health
Denver, Colorado, 80204
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
University of California, San Francisco
San Francisco, California, 94143
About this study
Cardiac rehabilitation is a medically recommended program for patients with certain heart conditions. It includes exercise training, health education, and counseling. Unfortunately, many patients do not participate in cardiac rehabilitation. Some find it challenging to attend the in-person sessions. This study aims to compare two methods of delivering cardiac rehabilitation: in-person and through telehealth. The investigators want to know if the effects of these two programs are alike and if certain individuals benefit more from one program over the other.
- Conditions
- Myocardial Infarction, Heart Failure, Systolic, Heart Valve Diseases, Angina, Stable, Coronary Artery Disease, Heart Transplant
- Being tested
- In-person cardiac rehabilitation, Telehealth cardiac rehabilitation
- Keywords
- cardiac rehabilitation, telehealth
- Medical subject headings
- Myocardial Infarction, Heart Failure, Systolic, Heart Valve Diseases, Angina, Stable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person cardiac rehabilitationBehavioural
In-person exercise training, health education, and counseling
Telehealth cardiac rehabilitationBehavioural
Telehealth exercise training, health education, and counseling
| Study group | Role | What they receive |
|---|---|---|
| In-person cardiac rehabilitation | Active comparator | Participants will participate in 12-week in-person cardiac rehabilitation as delivered at the site where they are enrolled. The typical course is 36 sessions of group exercise, health education, and counseling over 12 weeks. Receives: Behavioral: In-person cardiac rehabilitation |
| Telehealth cardiac rehabilitation | Active comparator | Participants will participate in 12-week telehealth cardiac rehabilitation. The program will follow the same core components as in-person cardiac rehabilitation, but in-person supervised exercise will not be required. The core element of telehealth cardiac rehabilitation is 12 weekly individual telehealth sessions between the patient and cardiac rehabilitation provider. Receives: Behavioral: Telehealth cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in six minute walk distance
The distance walked in six minute on a standard course will be measured in meters at baseline and 12 months.
Measured: Baseline and 12 months
Secondary outcomes (17)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 Scores - Mental Health
A change in PROMIS Global Health 10 scores will be measured during the first 12 months of the study. The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions with a 5-point ordinal rating scale of "Never," "Rarely," "Sometimes," "Often," and
Measured: Baseline and 12 months
Change in PROMIS Global Health 10 Scores - Physical Health
A change in PROMIS Global Health 10 scores will be measured during the first 12 months of the study. The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The physical health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better physical health.
Measured: Baseline and 12 months
Change in Generalized Anxiety Disorder (GAD)-7
A change in GAD-7 scores will be measured during the first 12 months of the study. The GAD-7 questionnaire is a self-assessed questionnaire that asks participants to respond to 7 questions with response option scores ranging from 0 to 3. The scale ranges from 0 to 21. Higher scores represent more anxiety symptoms.
Measured: Baseline and 12 months
Change in Patient Health Questionnaire (PHQ)-9
A change in PHQ-9 scores will be measured during the first 12 months of the study. The PHQ-7 questionnaire is a self-assessed questionnaire that asks participants to respond to 9 questions with response option scores ranging from 0 to 3. The scale ranges from 0 to 27. Higher scores represent more depressive symptoms.
Measured: Baseline and 12 months
Blood pressure control
Blood pressure less than 130/80 mmHg
Measured: 12 months
Participation in cardiac rehabilitation
Participation in CR, defined as proportion of core sessions attended (out of 36 sessions for in-person and 12 sessions for telehealth)
Measured: 12 months
Survival free of hospitalization for myocardial infarction, heart failure, or stroke/TIA.
Measured: 24 months
Change in PROMIS Global Health 10 Scores - Mental Health
A change in PROMIS Global Health 10 scores will be measured during the first 3 months of the study. The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions . The mental health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better mental health.
Measured: Baseline and 3 months
Change in PROMIS Global Health 10 Scores - Mental Health
A change in PROMIS Global Health 10 scores will be measured during the first 24 months of the study. The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions . The mental health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better mental health.
Measured: Baseline and 24 months
Change in PROMIS Global Health 10 Scores - Physical Health
A change in PROMIS Global Health 10 scores will be measured during the first 3 months of the study. The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The physical health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better physical health.
Measured: Baseline and 3 months
Change in PROMIS Global Health 10 Scores - Physical Health
A change in PROMIS Global Health 10 scores will be measured during the first 24 months of the study. The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The physical health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better physical health.
Measured: Baseline and 24 months
Change in GAD-7
A change in GAD-7 scores will be measured during the first 3 months of the study. The GAD-7 questionnaire is a self-assessed questionnaire that asks participants to respond to 7 questions with response option scores ranging from 0 to 3. The scale ranges from 0 to 21. Higher scores represent more anxiety symptoms.
Measured: Baseline and 3 months
Change in GAD-7
A change in GAD-7 scores will be measured during the first 24 months of the study. The GAD-7 questionnaire is a self-assessed questionnaire that asks participants to respond to 7 questions with response option scores ranging from 0 to 3. The scale ranges from 0 to 21. Higher scores represent more anxiety symptoms.
Measured: Baseline and 24 months
Change in PHQ-9
A change in PHQ-9 scores will be measured during the first 3 months of the study. The PHQ-7 questionnaire is a self-assessed questionnaire that asks participants to respond to 9 questions with response option scores ranging from 0 to 3. The scale ranges from 0 to 27. Higher scores represent more depressive symptoms.
Measured: 3 months
Change in PHQ-9
A change in PHQ-9 scores will be measured during the first 24 months of the study. The PHQ-7 questionnaire is a self-assessed questionnaire that asks participants to respond to 9 questions with response option scores ranging from 0 to 3. The scale ranges from 0 to 27. Higher scores represent more depressive symptoms.
Measured: 24 months
Blood pressure control
Blood pressure less than 130/80 mmHg
Measured: 3 months
Blood pressure control
Blood pressure less than 130/80 mmHg
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start27 Oct 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Masking
- None (open label)
- Enrolment
- 516 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Mayo Clinic, University of Michigan, University of Pittsburgh, Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Alexis Beatty, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933083
- Sponsor's protocol ID
- IHS-2021C3-24147
- Status last verified
- Sep 2026
- First submitted
- 27 Jun 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After study completion, the investigators will generate a de-identified dataset that may be shared with other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation
- ClinicalTrials.gov ID
- NCT05933083
- Acronym / sponsor ID
- IHS-2021C3-24147
- Conditions
- Myocardial Infarction, Heart Failure, Systolic, Heart Valve Diseases, Angina, Stable, Coronary Artery Disease, Heart Transplant
- Keywords
- cardiac rehabilitation, telehealth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 516 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Mayo Clinic, University of Michigan, University of Pittsburgh, Johns Hopkins University
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Jul 2023 (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 is a medically recommended program for patients with certain heart conditions. It includes exercise training, health education, and counseling. Unfortunately, many patients do not participate in cardiac rehabilitation. Some find it challenging to attend the in-person sessions. This study aims to compare two methods of delivering cardiac rehabilitation: in-person and through telehealth. The investigators want to know if the effects of these two programs are alike and if certain individuals benefit more from one program over the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person cardiac rehabilitation | Active comparator | Behavioral: In-person cardiac rehabilitationParticipants will participate in 12-week in-person cardiac rehabilitation as delivered at the site where they are enrolled. The typical course is 36 sessions of group exercise, health education, and counseling over 12 weeks. |
| Telehealth cardiac rehabilitation | Active comparator | Behavioral: Telehealth cardiac rehabilitationParticipants will participate in 12-week telehealth cardiac rehabilitation. The program will follow the same core components as in-person cardiac rehabilitation, but in-person supervised exercise will not be required. The core element of telehealth cardiac rehabilitation is 12 weekly individual telehealth sessions between the patient and cardiac rehabilitation provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 or older
- Eligible for cardiac rehabilitation
- Willing to be randomized to in-person or telehealth cardiac rehabilitation
- Able to communicate in English or Spanish
Key exclusion criteria (4 listed)
- Unstable arrhythmias which may make unmonitored exercise unsafe (e.g., history of ventricular tachycardia not on medical therapy and without an implantable cardioverter defibrillator)
- Unsafe for patient to participate in the opinion of the investigator
- Hospice
- Unable to consent for self
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 |
|---|---|---|
| In-person cardiac rehabilitationIn-person exercise training, health education, and counseling | Behavioural | In-person cardiac rehabilitation |
| Telehealth cardiac rehabilitationTelehealth exercise training, health education, and counseling | Behavioural | Telehealth cardiac rehabilitation |
Primary outcome
Change in six minute walk distance
Time frame: Baseline and 12 months
The distance walked in six minute on a standard course will be measured in meters at baseline and 12 months.
17 secondary outcomes
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 Scores - Mental Health
Time frame: Baseline and 12 months
Change in PROMIS Global Health 10 Scores - Physical Health
Time frame: Baseline and 12 months
Change in Generalized Anxiety Disorder (GAD)-7
Time frame: Baseline and 12 months
Change in Patient Health Questionnaire (PHQ)-9
Time frame: Baseline and 12 months
Blood pressure control
Time frame: 12 months
Participation in cardiac rehabilitation
Time frame: 12 months
Survival free of hospitalization for myocardial infarction, heart failure, or stroke/TIA.
Time frame: 24 months
Change in PROMIS Global Health 10 Scores - Mental Health
Time frame: Baseline and 3 months
Change in PROMIS Global Health 10 Scores - Mental Health
Time frame: Baseline and 24 months
Change in PROMIS Global Health 10 Scores - Physical Health
Time frame: Baseline and 3 months
Change in PROMIS Global Health 10 Scores - Physical Health
Time frame: Baseline and 24 months
Change in GAD-7
Time frame: Baseline and 3 months
Change in GAD-7
Time frame: Baseline and 24 months
Change in PHQ-9
Time frame: 3 months
Change in PHQ-9
Time frame: 24 months
Blood pressure control
Time frame: 3 months
Blood pressure control
Time frame: 24 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 2 Sep 2026.
- Individual participant dataSharing planned: Yes. After study completion, the investigators will generate a de-identified dataset that may be shared with other researchers upon request.
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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. This study is not recruiting at the moment.
Alexis Beatty, MD, MAS principal investigator
University of California, San Francisco
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person cardiac rehabilitation and Telehealth cardiac rehabilitation in people with Myocardial Infarction and Heart Failure, Systolic, run by University of California, San Francisco at 5 sites 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 13 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in six minute walk distance (time frame: Baseline and 12 months). 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 2 Sep 2026.