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

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

Overview

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.

Interventions

• Device 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.
• Behavioral Mindfulness Therapy
  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 sham CRIC
  The pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as those of the CIRC group.
• Behavioral sham MFT
  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 outcome measures

• Incidence of MACE [Time frame: 12 months]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Fuwai Central China Cardiovascular Hospital — Zhengzhou

Identifiers

NCT: NCT06820970 · HenanICE202501

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗