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

Henan Institute of Cardiovascular Epidemiology

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Behavioral: Mindfulness Therapy; Other: sham CRIC; Device: chronic remote ischemic conditioning; Behavioral: sham MFT

Study type: Interventional

Funder types: Other

Identifiers

NCT06820970

HenanICE202501

Details and patient eligibility

About

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.

Enrollment: 3,420 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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3,420 participants in 4 patient groups

CRIC+MFT

Experimental group

Description:

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. 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.

Treatment:

Device: chronic remote ischemic conditioning

Behavioral: Mindfulness Therapy

Control (neither CRIC nor MFT).

Sham Comparator group

Description:

Sham 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).

Treatment:

Behavioral: sham MFT

Other: sham CRIC

CRIC+sham MFT

Sham Comparator group

Description:

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. 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).

Treatment:

Behavioral: sham MFT

Device: chronic remote ischemic conditioning

Sham CRIC+MFT

Sham Comparator group

Description:

Sham 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.

Treatment:

Other: sham CRIC

Behavioral: Mindfulness Therapy