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NCT Number: NCT06820970

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.);

Exclusion criteria

  • 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)
  • 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.

Treatment and study plan

chronic remote ischemic conditioning

Device

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.

Other names: CRIC

Mindfulness therapy

Behavioral

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.

Other names: MFT

sham CRIC

Other

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

sham MFT

Behavioral

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).

Primary outcomes

  1. Incidence of MACE

    Time frame: 12 months

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

Secondary outcomes

  1. Incidence of Cardiac Death

    Time frame: 3,6,9,12,24months

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

  2. Incidence of Non-fatal Myocardial Infarction

    Time frame: 3,6,9,12,24months

    Includes STEMI and NSTEMI with elevated serum troponin on the basis of patient symptoms or ECG changes

  3. Incidence of hospitalisation for new-onset heart failure

    Time frame: 3,6,9,12,24months

    New onset of heart failure-related symptoms with elevated serum BNP or NT-ProBNP

  4. Incidence of hospitalised for angina pectoris

    Time frame: 3,6,9,12,24months

    Hospitalisation for angina pectoris symptoms of all causes, with a discharge diagnosis of angina pectoris

  5. Incidence of unplanned revascularisation

    Time frame: 3,6,9,12,24months

    Unplanned revascularisation

  6. Incidence of all cause death

    Time frame: 3,6,9,12,24months

    Death from any cause

  7. Incidence of total length of hospitalization due to coronary heart disease

    Time frame: 3,6,9,12,24months

    Refers to the number of days when all hospitalizations for all causes of coronary heart disease are stacked together

  8. Medical expenses due to coronary heart disease

    Time frame: 3,6,9,12,24months

    Refers to medical expenses incurred as a result of coronary heart disease

  9. Degree of improvement in angina symptoms

    Time frame: 3,6,9,12,24months

    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.

  10. Change in anxiety scores

    Time frame: 3,6,9,12,24months

    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).

  11. Change in depression scores

    Time frame: 3,6,9,12,24months

    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).

  12. Changes in sleep quality

    Time frame: 3,6,9,12,24months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Quan Guo, MD

CONTACT

[email protected]

15670510031

Sponsors and collaborators

Lead sponsor

Henan Institute of Cardiovascular Epidemiology

Other

Registry information

Official study 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

Acronym: CRCMF

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Feb 11, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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