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Coronary Artery DiseaseCRCMFNCT06820970

CRIC Combined With MFT for Cardiovascular Adverse Events in Patients With Incomplete Revascularization of CAD

A study testing chronic remote ischemic conditioning and Mindfulness Therapy in people with Coronary Artery Disease, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main objective of this study is to demonstrate whether the combination of chronic remote ischemic conditioning and mindfulness therapy can reduce cardiovascular adverse events 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 Artery Disease
What is being tested?
chronic remote ischemic conditioning and Mindfulness Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,000 participants
Where
1 siteChina
Study dates
1 Aug 2025to 30 Dec 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

  • 1) Age ≥18 years old
  • 2) 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)
  • 3) 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

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan, 450000

    GUO QUAN, MD, 15670510031, xinyiguoquan@163.com

    lmw0207@163.com

    Recruiting

Other trials in China

About this study

Official title: Chronic Remote Ischemic Conditioning Combined With Mindfulness Therapy for Cardiovascular Adverse Events 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 reduce cardiovascular adverse events in patients with incomplete revascularization of coronary artery disease.

Being tested
chronic remote ischemic conditioning, Mindfulness Therapy, sham CRIC, sham MFT
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chronic remote ischemic conditioningDevice

    Also called CRIC

    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.

  • Mindfulness TherapyBehavioural

    Also called 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.

  • sham CRICOther

    The pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as those of the CIRC group.

  • sham MFTBehavioural

    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), excluding mindfulness-specific techniques (no present-moment/nonjudgmental awareness training, no breath-focused meditation, no open monitoring).

Study groups in NCT06820970
Study groupRoleWhat they receive
CRIC+MFTExperimentalCIRC: 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. 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: chronic remote ischemic conditioning; Behavioral: Mindfulness Therapy
Control (neither CRIC nor MFT).Sham comparatorSham CRIC: The pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as in the CIRC group. 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), excluding mindfulness-specific techniques (no present-moment/nonjudgmental awareness training, no breath-focused meditation, no open monitoring).
Receives: Other: sham CRIC; Behavioral: sham MFT
CRIC+sham MFTSham comparatorCIRC: 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. 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), excluding mindfulness-specific techniques (no present-moment/nonjudgmental awareness training, no breath-focused meditation, no open monitoring).
Receives: Device: chronic remote ischemic conditioning; Behavioral: sham MFT
Sham CRIC+MFTSham comparatorSham CRIC: The pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as in the CIRC group. 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: Mindfulness Therapy; Other: sham CRIC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of MACE

    Clinical events were defined as: cardiac death, nonfatal myocardial infarction, hospitalization for new heart failure, hospitalization for angina pectoris

    Measured: 12 months

Secondary outcomes (12)
  1. Incidence of Cardiac Death

    Death is considered cardiac unless there is clear evidence of non-cardiac death

    Measured: 3,6,9,12,24months

  2. 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

  3. 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

  4. 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

  5. Incidence of unplanned revascularisation

    Unplanned revascularisation

    Measured: 3,6,9,12,24months

  6. Incidence of all cause death

    Death from any cause

    Measured: 3,6,9,12,24months

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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 components 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2025
  2. Study start1 Aug 2025
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion30 Dec 2029 (estimated)

Resources

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 anxiety and sleep quality 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
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06820970
Sponsor's protocol ID
HenanICE202501
Acronym
CRCMF
Status last verified
Apr 2026
First submitted
6 Feb 2025
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing chronic remote ischemic conditioning and Mindfulness Therapy in people with Coronary Artery Disease, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.

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: looking for participants now, as of the sponsor's last update on 6 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 China. 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. 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, MD (15670510031, xinyiguoquan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of MACE (time frame: 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 6 Apr 2026.

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