Coronary DiseaseCRMF-MFRNCT07514624
CRIC Combined With MFT for MFR in Patients With Incomplete Revascularization of CAD
A study testing CRIC and MFT in people with Coronary Disease, run by Henan Institute of Cardiovascular Epidemiology.
Trial summary
The main objective of this study is to demonstrate whether the combination of chronic remote ischemic conditioning and mindfulness therapy can improve myocardial flow reserve in patients with incomplete revascularization of coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- CRIC and MFT
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 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 years old
- Consistent with the diagnosis of coronary heart disease, complete revascularization was not performed (coronary angiography showed that at least one vessel with a reference diameter of 3.0mm had stenosis greater than 90%, and quantitative flow ratio (QFR) < 0.80)
- Symptoms of myocardial ischemia (resting or exertional angina; Angina allele: chest tightness, shortness of breath, etc.);
Who cannot join
- • Age < 18 years old
- Heart failure patients with NYHA class IV, or left ventricular ejection fraction (LVEF) < 30%
- Creatinine clearance <15 mL/min (or eGFR < 15 mL/min/1.73m²), or requires dialysis
- Myocardial diseases such as hypertrophic cardiomyopathy, dilated cardiomyopathy, etc.
- Uncontrolled or recurrent arrhythmic events (e.g., ventricular fibrillation, recurrent or symptomatic sustained ventricular tachycardia, complete heart block, atrial fibrillation with rapid ventricular rates, supraventricular tachycardia refractory to drugs)
- Poorly controlled hypertension (SBP > 180 mm Hg or DBP > 110 mm Hg)
Show all 18Show fewer
- Active liver disease or persistent ALT or AST elevation ≥ 3 times the upper limit of normal
- Unexplained CK > 5 times the upper limit of normal, or elevated CK due to known muscle disease
- Planned or anticipated cardiac surgery or revascularization before randomization
- History of active malignancy (surgery, radiation therapy, and/or systemic therapy within the past 3 years)
- Diagnosed or suspected upper extremity vascular malformations, aneurysms, arteriovenous fistulas, or thrombosis
- Hearing impairment, unable to undergo mindfulness therapy
- Currently participating in another drug or device study, or within 30 days of completing another drug or device study or receiving another investigational drug
- Any life-threatening comorbid conditions expected to result in death within the next year (excluding cardiovascular diseases)
- Alcoholism, substance abuse history; and unwilling or unable to stop alcohol or substance abuse during the study
- History of major organ transplant (e.g., lung, liver, heart, bone marrow, kidney)
- Investigator's judgment of known major active and uncontrolled disease, or any medical, physical, or surgical conditions (e.g., infection, significant blood, kidney, metabolic, gastrointestinal, or endocrine dysfunction) that may interfere with participation in the clinical study
- As known to the investigator, the subject is unlikely to complete follow-up for more than 1 year or is expected to be unable to comply with the study requirements or understand the study's objectives and potential risks.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Chronic Remote Ischemic Conditioning Combined With Mindfulness Therapy for Myocardial Flow Reserve in Patients With Incomplete Revascularization of Coronary Artery Disease: A Multicenter, Double-blind, Randomized Controlled Trial
The main objective of this study is to demonstrate whether the combination of chronic remote ischemic conditioning and mindfulness therapy can improve myocardial flow reserve in patients with incomplete revascularization of coronary artery disease.
- Conditions
- Coronary Disease
- Being tested
- CRIC, MFT, sham CIRC, sham MFT
- Keywords
- CAD, MFR, RIPC
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRICDevice
chronic remote ischemic conditioning Using a semi-automated machine, the pressure is increased according to the patient's own blood pressure level (20-40mmHg) when the cuff is pressed, and the pressure is squeezed for 6 minutes per cycle and the rest is 4 minutes, for a total of 4 cycles per cycle.
MFTBehavioural
Participants receive guided mindfulness audio sessions twice daily for ~30 minutes each throughout the perioperative period. Content includes standardized mindfulness practices (e.g., focused attention, body awareness, nonjudgmental observation) designed to reduce anxiety and improve sleep quality.
sham CIRCDevice
The pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as in the CIRC group.
sham MFTBehavioural
A time- and attention-matched audio program (twice daily, 30 minutes) delivering perioperative recovery and sleep-hygiene education with passive relaxation (music or simple muscle loosening), excluding mindfulness-specific techniques (no present-moment/ nonjudgmental awareness training, no breath-focused meditation, no open monitoring).
| Study group | Role | What they receive |
|---|---|---|
| CRIC+MFT | Experimental | CIRC: Using a semi-automated machine, the pressure is increased according to the patient's own blood pressure level (20-40mmHg) when the cuff is pressed, and the pressure is compressed for 6 minutes per cycle, and the rest is 4 minutes per cycle. Perform twice daily, with 4 cycles per session.
MFT: Participants receive guided mindfulness audio sessions twice daily for ~30 minutes each throughout the perioperative period. Content includes standardized mindfulness practices (e.g., focused attention, body awareness, nonjudgmental observation) designed to reduce anxiety and improve sleep quality. Receives: Device: CRIC; Behavioral: MFT |
| Control (neither CRIC nor MFT). | Sham comparator | Sham CRIC: The pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as those of the CIRC group. Perform twice daily, with 4 cycles per session.
Sham MFT: Health Education + Relaxation (HER):A time- and attention-matched audio program (twice daily, 30 minutes) delivering perioperative recovery and sleep-hygiene education with passive relaxation(music or simple muscle loosening), excludingmindfulness-specific techniques (no present-moment/ nonjudgmental awareness training, no breath-focused meditation, no open monitoring). Receives: Device: sham CIRC; Behavioral: sham MFT |
| CRIC+sham MFT | Sham comparator | CIRC: Using a semi-automated machine, the pressure is increased according to the patient's own blood pressure level (20-40mmHg) when the cuff is pressed, and the pressure is compressed for 6 minutes per cycle, and the rest is 4 minutes per cycle. Perform twice daily, with 4 cycles per session.
Sham MFT: Health Education + Relaxation (HER):A time- and attention-matched audio program (twice daily, 30 minutes) delivering perioperative recovery and sleep-hygiene education with passive relaxation(music or simple muscle loosening), excludingmindfulness-specific techniques (no present-moment/ nonjudgmental awareness training, no breath-focused meditation, no open monitoring). Receives: Device: CRIC; Behavioral: sham MFT |
| sham CRIC+MFT | Sham comparator | Sham CRIC: The pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as those of the CIRC group. Perform twice daily, with 4 cycles per session.
MFT: Participants receive guided mindfulness audio sessions twice daily for ~30 minutes each throughout the perioperative period. Content includes standardized mindfulness practices (e.g., focused attention, body awareness, nonjudgmental observation) designed to reduce anxiety and improve sleep quality. Receives: Behavioral: MFT; Device: sham CIRC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Myocardial Flow Reserve (MFR)
Change in myocardial flow reserve (MFR) assessed by CT myocardial perfusion imaging from baseline to 6 months after randomization.
Measured: 6 months
Secondary outcomes (17)
Incidence of MACE
Clinical events were defined as: cardiac death, nonfatal myocardial infarction, hospitalization for new heart failure,hospitalization for angina pectoris
Measured: 3,6,9,12,24months
Incidence of Cardiac Death
Death is considered cardiac unless there is clear evidence of non-cardiac death
Measured: 3,6,9,12,24months
Incidence of Non-fatal Myocardial Infarction
Includes STEMI and NSTEMI with elevated serum troponin on the basis of patient symptoms or ECG changes
Measured: 3,6,9,12,24months
Incidence of hospitalisation for new-onset heart failure
New onset of heart failure-related symptoms with elevated serum BNP or NT-ProBNP
Measured: 3,6,9,12,24months
Incidence of hospitalised for angina pectoris
Hospitalisation for angina pectoris symptoms of all causes, with a discharge diagnosis of angina pectoris
Measured: 3,6,9,12,24months
Incidence of unplanned revascularisation
Unplanned revascularisation
Measured: 3,6,9,12,24months
Incidence of all cause death
Death from any cause
Measured: 3,6,9,12,24months
Incidence of total length of hospitalization due to coronary heart disease
Refers to the number of days when all hospitalizations for all causes of coronary heart disease are stacked together
Measured: 3,6,9,12,24months
Medical expenses due to coronary heart disease
Refers to medical expenses incurred as a result of coronary heart disease
Measured: 3,6,9,12,24months
Degree of improvement in angina symptoms
The degree of improvement in angina symptoms will be assessed using the Seattle Angina Questionnaire (SAQ), a 19-item self-administered questionnaire that evaluates five domains of health status in patients with coronary artery disease: physical limitation (9 items), angina stability (1 item), angina frequency (2 items), treatment satisfaction (4 items), and disease perception (3 items). Each domain score ranges from 0 to 100, with higher scores indicating better function (e.g., less physical limitation, less frequent angina, and better quality of life). A summary score, averaging the physical limitation, angina frequency, and quality of life domains, also ranges from 0 to 100. Improvement will be measured as the change in SAQ domain scores and summary score from baseline to follow-up time points, where an increase of 10 points or more in any domain or the summary score is considered clinically significant.
Measured: 3,6,9,12,24months
Change in anxiety scores
Changes in anxiety scores will be assessed using the Zung Self-Rating Anxiety Scale (SAS), a 20-item self-report questionnaire that measures anxiety symptoms across cognitive, autonomic, motor, and central nervous system domains. Each item is rated on a 4-point Likert scale (1 = "none or a little of the time" to 4 = "most or all of the time"), yielding a raw total score ranging from 20 to 80, with higher scores indicating greater anxiety severity. Raw scores can be converted to an index score by multiplying by 1.25 (range: 25 to 100). The change in anxiety scores will be calculated as the difference in raw SAS scores from baseline to follow-up time points. For reference, raw scores are typically interpreted as: <36 (normal), 36-47 (mild anxiety), 48-59 (moderate anxiety), and ≥60 (severe anxiety).
Measured: 3,6,9,12,24months
Change in depression scores
Changes in depression scores will be assessed using the Zung Self-Rating Depression Scale (SDS), a 20-item self- report questionnaire that measures depressive symptoms across affective, psychological, and somatic domains. Each item is rated on a 4-point Likert scale (1 = "none or a little of the time" to 4 = "most or all of the time"), yielding a raw total score ranging from 20 to 80, with higher scores indicating greater depression severity. Raw scores can be converted to an index score by multiplying by 1.25 (range: 25 to 100). The change in depression scores will be calculated as the difference in raw SDS scores from baseline to follow-up time points. For reference, raw scores are typically interpreted as: <40 (normal), 40-47 (mild depression), 48-55 (moderate depression), and ≥56 (severe depression).
Measured: 3,6,9,12,24months
Changes in sleep quality
Changes in sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire that evaluates sleep quality over the past month across seven components: subjective sleep quality (1 item), sleep latency (2 items), sleep duration (1 item), habitual sleep efficiency (3 items), sleep disturbances (9 items), use of sleeping medication (1 item), and daytime dysfunction (2 items). Each component is scored from 0 to 3, with higher scores indicating greater dysfunction. The global PSQI score is the sum of the seven omponents and ranges from 0 to 21, with higher scores indicating poorer sleep quality. Changes in sleep quality will be calculated as the difference in global PSQI scores from baseline to follow-up time points. For reference, a global score >5 is indicative of poor sleep quality.
Measured: 3,6,9,12,24months
Mean Nocturnal Systolic Blood Pressure
Measurement using smart wearable devices
Measured: 3,6,9,12,24months
Average sleep duration (hours per night)
Average total sleep time per night, measured using a smart wearable device. Data will be reported as mean (±SD) hours per night.
Measured: 3,6,9,12,24months
average heart rate
Measurement using smart wearable devices
Measured: 3,6,9,12,24months
Sleep quality (measured by sleep efficiency, %)
Sleep efficiency (%) assessed using a smart wearable device, defined as the ratio of total sleep time to time in bed. Data will be reported as mean (±SD) percentage. Higher values indicate better sleep quality.
Measured: 3,6,9,12,24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- 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
- Factorial
- Model description
- This study adopts a 2×2 factorial randomized controlled trial design to evaluate the independent and combined effects of chronic remote ischemic preconditioning (CRIC) and mindfulness therapy (MFT) on myocardial flow reserve in patients with coronary heart disease. Participants will be randomly assigned to one of four groups: (1) CRIC plus MFT, (2) CRIC only, (3) MFT only, or (4) neither intervention (control). The design allows the assessment of the main effects of RIPC and MBT, as well as the potential interaction effect between the two interventions.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muwei LI, Study chair, Fuwai Central China of Cardiovascular Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514624
- Sponsor's protocol ID
- HenanlCE202504
- Acronym
- CRMF-MFR
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Remote Ischemic Conditioning Combined With Mindfulness Therapy for Myocardial Flow Reserve in Patients With Incomplete Revascularization of Coronary Artery Disease: A Multicenter, Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07514624
- Acronym / sponsor ID
- CRMF-MFR / HenanlCE202504
- Conditions
- Coronary Disease
- Keywords
- CAD, MFR, RIPC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 7 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.
The main objective of this study is to demonstrate whether the combination of chronic remote ischemic conditioning and mindfulness therapy can improve myocardial flow reserve in patients with incomplete revascularization of coronary artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This study adopts a 2×2 factorial randomized controlled trial design to evaluate the independent and combined effects of chronic remote ischemic preconditioning (CRIC) and mindfulness therapy (MFT) on myocardial flow reserve in patients with coronary heart disease. Participants will be randomly assigned to one of four groups: (1) CRIC plus MFT, (2) CRIC only, (3) MFT only, or (4) neither intervention (control). The design allows the assessment of the main effects of RIPC and MBT, as well as the potential interaction effect between the two interventions.
| Arm | Type | Receives |
|---|---|---|
| CRIC+MFT | Experimental | Device: CRIC, Behavioral: MFTCIRC: Using a semi-automated machine, the pressure is increased according to the patient's own blood pressure level (20-40mmHg) when the cuff is pressed, and the pressure is compressed for 6 minutes per cycle, and the rest is 4 minutes per cycle. Perform twice daily, with 4 cycles per session. MFT: Participants receive guided mindfulness audio sessions twice daily for ~30 minutes each throughout the perioperative period. Content includes standardized mindfulness practices (e.g., focused attention, body awareness, nonjudgmental observation) designed to reduce anxiety and improve sleep quality. |
| Control (neither CRIC nor MFT). | Sham comparator | Device: sham CIRC, Behavioral: sham MFTSham CRIC: The pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as those of the CIRC group. Perform twice daily, with 4 cycles per session. Sham MFT: Health Education + Relaxation (HER):A time- and attention-matched audio program (twice daily, 30 minutes) delivering perioperative recovery and sleep-hygiene education with passive relaxation(music or simple muscle loosening), excludingmindfulness-specific techniques (no present-moment/ nonjudgmental awareness training, no breath-focused meditation, no open monitoring). |
| CRIC+sham MFT | Sham comparator | Device: CRIC, Behavioral: sham MFTCIRC: Using a semi-automated machine, the pressure is increased according to the patient's own blood pressure level (20-40mmHg) when the cuff is pressed, and the pressure is compressed for 6 minutes per cycle, and the rest is 4 minutes per cycle. Perform twice daily, with 4 cycles per session. Sham MFT: Health Education + Relaxation (HER):A time- and attention-matched audio program (twice daily, 30 minutes) delivering perioperative recovery and sleep-hygiene education with passive relaxation(music or simple muscle loosening), excludingmindfulness-specific techniques (no present-moment/ nonjudgmental awareness training, no breath-focused meditation, no open monitoring). |
| sham CRIC+MFT | Sham comparator | Behavioral: MFT, Device: sham CIRCSham CRIC: The pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as those of the CIRC group. Perform twice daily, with 4 cycles per session. MFT: Participants receive guided mindfulness audio sessions twice daily for ~30 minutes each throughout the perioperative period. Content includes standardized mindfulness practices (e.g., focused attention, body awareness, nonjudgmental observation) designed to reduce anxiety and improve sleep quality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years old
- Consistent with the diagnosis of coronary heart disease, complete revascularization was not performed (coronary angiography showed that at least one vessel with a reference diameter of 3.0mm had stenosis greater than 90%, and quantitative flow ratio (QFR) < 0.80)
- Symptoms of myocardial ischemia (resting or exertional angina; Angina allele: chest tightness, shortness of breath, etc.);
Key exclusion criteria (18 listed)
- • Age < 18 years old
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 |
|---|---|---|
| CRICchronic remote ischemic conditioning Using a semi-automated machine, the pressure is increased according to the patient's own blood pressure level (20-40mmHg) when the cuff is pressed, and the pressure is squeezed for 6 minutes per cycle and the rest is 4 minutes, for a total of 4 cycles per cycle. | Device | CRIC+MFT, CRIC+sham MFT |
| MFTParticipants receive guided mindfulness audio sessions twice daily for ~30 minutes each throughout the perioperative period. Content includes standardized mindfulness practices (e.g., focused attention, body awareness, nonjudgmental observation) designed to reduce anxiety and improve sleep quality. | Behavioural | CRIC+MFT, sham CRIC+MFT |
| sham CIRCThe pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as in the CIRC group. | Device | Control (neither CRIC nor MFT)., sham CRIC+MFT |
| sham MFTA time- and attention-matched audio program (twice daily, 30 minutes) delivering perioperative recovery and sleep-hygiene education with passive relaxation (music or simple muscle loosening), excluding mindfulness-specific techniques (no present-moment/ nonjudgmental awareness training, no breath-focused meditation, no open monitoring). | Behavioural | CRIC+sham MFT, Control (neither CRIC nor MFT). |
Primary outcome
Change in Myocardial Flow Reserve (MFR)
Time frame: 6 months
Change in myocardial flow reserve (MFR) assessed by CT myocardial perfusion imaging from baseline to 6 months after randomization.
17 secondary outcomes
Incidence of MACE
Time frame: 3,6,9,12,24months
Incidence of Cardiac Death
Time frame: 3,6,9,12,24months
Incidence of Non-fatal Myocardial Infarction
Time frame: 3,6,9,12,24months
Incidence of hospitalisation for new-onset heart failure
Time frame: 3,6,9,12,24months
Incidence of hospitalised for angina pectoris
Time frame: 3,6,9,12,24months
Incidence of unplanned revascularisation
Time frame: 3,6,9,12,24months
Incidence of all cause death
Time frame: 3,6,9,12,24months
Incidence of total length of hospitalization due to coronary heart disease
Time frame: 3,6,9,12,24months
Medical expenses due to coronary heart disease
Time frame: 3,6,9,12,24months
Degree of improvement in angina symptoms
Time frame: 3,6,9,12,24months
Change in anxiety scores
Time frame: 3,6,9,12,24months
Change in depression scores
Time frame: 3,6,9,12,24months
Changes in sleep quality
Time frame: 3,6,9,12,24months
Mean Nocturnal Systolic Blood Pressure
Time frame: 3,6,9,12,24months
Average sleep duration (hours per night)
Time frame: 3,6,9,12,24months
average heart rate
Time frame: 3,6,9,12,24months
Sleep quality (measured by sleep efficiency, %)
Time frame: 3,6,9,12,24months
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 7 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Muwei LI study chair
Fuwai Central China of Cardiovascular Hospital
Questions about this trial
What is this clinical trial studying?
A study testing CRIC and MFT in people with Coronary Disease, run by Henan Institute of Cardiovascular Epidemiology.
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 3 inclusion and 18 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: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Quan Guo (15670510031, xinyiguoquan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Myocardial Flow Reserve (MFR) (time frame: 6 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 7 Apr 2026.