IschemiaNCT06829160
mHealth-CArdiac REhabilitation for INOCA
A study testing Communication with exercise therapist, mHealth-CR and Wearable activity monitoring device in people with Ischemia, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia
- What is being tested?
- Communication with exercise therapist, mHealth-CR and Wearable activity monitoring device
- 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
- 21 Mar 2025to 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 and over
- Diagnosis of Ischemia with Non-Obstructive Coronary Arteries (INOCA) based on evidence of ischemia and/or ischemic symptoms, plus non-obstructive Coronary artery disease (CAD) on computed tomography (CT) or invasive angiography
Who cannot join
- Seattle Angina Questionnaire (SAQ) = 100
- Non-ambulatory
- Pregnant
- Moderate or severe cognitive impairment
- Unable/willing to provide consent
- Incarcerated
Show all 13Show fewer
- Unable to use mHealth
- Severe osteoarthritis or joint replacement within 3 months
- Parkinsons disease or other movement disorders
- Regular use of walker
- Life expectancy < 12 months
- Clinical judgement concerning other safety or non-adherence issues
- Unable to read and communicate in English since the app content is currently only available in English.
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
NYU Langone Health
New York, New York, 10016
About this study
Official title: mHealth-CArdiac REhabilitation for INOCA (INOCA-CARE)
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
- Ischemia
- Being tested
- Communication with exercise therapist, mHealth-CR, Wearable activity monitoring device
- Keywords
- INOCA, ANOCA, Ischemia, no obstructive coronary artery disease
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication with exercise therapistBehavioural
A personalized exercise program will be designed. The assigned therapist will identify potential barriers to this plan and develop mitigation strategies. The assigned therapist will then make phone contact with participants weekly for the duration of the study. Exercise recommendations will be titrated during calls based on review of activity data.
mHealth-CRBehavioural
mHealth-CR software (currently, from Corrie Health) will permit 1) participant data entry about exercise; 2) viewing of educational material pertinent to the condition.
Wearable activity monitoring deviceBehavioural
Participants will be offered the Fitbit Charge 5. This commercially available product measures physical activity.
| Study group | Role | What they receive |
|---|---|---|
| mHealth-Cardiac Rehabilitation (CR) | Experimental | Participants in the mHealth-CR arm will receive daily therapist-directed activity and weekly phone calls, use a mHealth-CR app to track activity, heart rate and access educational materials, and use a wearable wrist activity monitoring device (such as Fitbit or Apple Watch). Receives: Behavioral: Communication with exercise therapist; Behavioral: mHealth-CR; Behavioral: Wearable activity monitoring device |
| Usual Care | Active comparator | Participants in usual care arm will receive standard medical care as determined by their physician. They will also use a wearable wrist activity monitoring device. Receives: Behavioral: Wearable activity monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Seattle Angina Questionnaire (SAQ) score
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).
Measured: Baseline, Month 3
Change in Seattle Angina Questionnaire (SAQ) score
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).
Measured: Baseline, Month 12
Weekly percent completion of the mHealth-CR program
Weekly engagement will be measured as the fraction of the following elements completed each week: exercise therapy-directed activities, daily entry of exercise data and rated perceived exertion (RPE); completed weekly phone call with exercise therapist; at least one communication with exercise therapist (outside weekly phone call); reviewing educational video/text (which will vary by week).
Competition will be assessed as a pseudo-continuous outcome, as the score can range from 0% (0 activities completed) to 100% (all activities completed) incorporating values for each activity.
Measured: Month 3
Secondary outcomes (9)
Change in step count
Step count is measured on a continuous basis and data will be obtained from the wearable activity monitoring device.
Measured: Week 1, Month 3
Change in step count
Step count is measured on a continuous basis and data will be obtained from the wearable activity monitoring device.
Measured: Week 1, Month 12
Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score
The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Measured: Baseline, Month 3
Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score
The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Measured: Baseline, Month 12
Change in visual analogue scale (VAS) score
VAS indicates the general health status (VAS; ranges from 0-100). Higher scores indicating the better health status.
Measured: Baseline, Month 3
Change in visual analogue scale (VAS) score
VAS indicates the general health status (VAS; ranges from 0-100). Higher scores indicating the better health status.
Measured: Baseline, Month 12
Change in patient Health Questionnaire - 8 Items (PHQ-8) score
The PHQ-8 is a self-reported measure of depressive symptoms composed of 8 Likert type items with a response scale ranging from 0 (Not at all) to 3 (Nearly every day), that refer to the presence of that symptom during the previous 2 weeks. The PHQ-8 final score is obtained by adding the score for each of the items, ranging from 0 to 24 (higher scores corresponding to higher levels of depression).
Measured: Baseline, Month 3
Change in patient Health Questionnaire - 8 Items (PHQ-8) score
The PHQ-8 is a self-reported measure of depressive symptoms composed of 8 Likert type items with a response scale ranging from 0 (Not at all) to 3 (Nearly every day), that refer to the presence of that symptom during the previous 2 weeks. The PHQ-8 final score is obtained by adding the score for each of the items, ranging from 0 to 24 (higher scores corresponding to higher levels of depression).
Measured: Baseline, Month 12
Change in exercise time on treadmill stress test
The treadmill stress test measures how well the participants heart works during physical activity. This test will take about 30 minutes in total, with about 10-15 minutes spent exercising.
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start21 Mar 2025
- Primary completionJul 2027 (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 IschemiaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Harmony Reynolds, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829160
- Sponsor's protocol ID
- 23-01040
- Other IDs
- 1R01HL170666-01
- Status last verified
- Apr 2026
- First submitted
- 11 Feb 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: harmony.reynolds@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth-CArdiac REhabilitation for INOCA (INOCA-CARE)
- ClinicalTrials.gov ID
- NCT06829160
- Acronym / sponsor ID
- 23-01040
- Conditions
- Ischemia
- Keywords
- INOCA, ANOCA, Ischemia, no obstructive coronary artery disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 17 Feb 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth-Cardiac Rehabilitation (CR) | Experimental | Behavioral: Communication with exercise therapist, Behavioral: mHealth-CR, Behavioral: Wearable activity monitoring deviceParticipants in the mHealth-CR arm will receive daily therapist-directed activity and weekly phone calls, use a mHealth-CR app to track activity, heart rate and access educational materials, and use a wearable wrist activity monitoring device (such as Fitbit or Apple Watch). |
| Usual Care | Active comparator | Behavioral: Wearable activity monitoring deviceParticipants in usual care arm will receive standard medical care as determined by their physician. They will also use a wearable wrist activity monitoring device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 and over
- Diagnosis of Ischemia with Non-Obstructive Coronary Arteries (INOCA) based on evidence of ischemia and/or ischemic symptoms, plus non-obstructive Coronary artery disease (CAD) on computed tomography (CT) or invasive angiography
Key exclusion criteria (13 listed)
- Seattle Angina Questionnaire (SAQ) = 100
- Non-ambulatory
- Pregnant
- Moderate or severe cognitive impairment
- Unable/willing to provide consent
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 |
|---|---|---|
| Communication with exercise therapistA personalized exercise program will be designed. The assigned therapist will identify potential barriers to this plan and develop mitigation strategies. The assigned therapist will then make phone contact with participants weekly for the duration of the study. Exercise recommendations will be titrated during calls based on review of activity data. | Behavioural | mHealth-Cardiac Rehabilitation (CR) |
| mHealth-CRmHealth-CR software (currently, from Corrie Health) will permit 1) participant data entry about exercise; 2) viewing of educational material pertinent to the condition. | Behavioural | mHealth-Cardiac Rehabilitation (CR) |
| Wearable activity monitoring deviceParticipants will be offered the Fitbit Charge 5. This commercially available product measures physical activity. | Behavioural | Usual Care, mHealth-Cardiac Rehabilitation (CR) |
Primary outcome
Change in Seattle Angina Questionnaire (SAQ) score
Time frame: Baseline, Month 3
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).
Change in Seattle Angina Questionnaire (SAQ) score
Time frame: Baseline, Month 12
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).
Weekly percent completion of the mHealth-CR program
Time frame: Month 3
Weekly engagement will be measured as the fraction of the following elements completed each week: exercise therapy-directed activities, daily entry of exercise data and rated perceived exertion (RPE); completed weekly phone call with exercise therapist; at least one communication with exercise therapist (outside weekly phone call); reviewing educational video/text (which will vary by week). Competition will be assessed as a pseudo-continuous outcome, as the score can range from 0% (0 activities completed) to 100% (all activities completed) incorporating values for each activity.
9 secondary outcomes
Change in step count
Time frame: Week 1, Month 3
Change in step count
Time frame: Week 1, Month 12
Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score
Time frame: Baseline, Month 3
Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score
Time frame: Baseline, Month 12
Change in visual analogue scale (VAS) score
Time frame: Baseline, Month 3
Change in visual analogue scale (VAS) score
Time frame: Baseline, Month 12
Change in patient Health Questionnaire - 8 Items (PHQ-8) score
Time frame: Baseline, Month 3
Change in patient Health Questionnaire - 8 Items (PHQ-8) score
Time frame: Baseline, Month 12
Change in exercise time on treadmill stress test
Time frame: Baseline, Month 3
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 23 Apr 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: harmony.reynolds@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Harmony Reynolds, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication with exercise therapist, mHealth-CR and Wearable activity monitoring device in people with Ischemia, run by NYU Langone Health 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 2 inclusion and 13 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 23 Apr 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 Harmony Reynolds, MD (212-263-7751, INOCA@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Seattle Angina Questionnaire (SAQ) score (time frame: Baseline, Month 3). The study lists 3 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 23 Apr 2026.