About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.);
Disqualifiers
• 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.
Trial design
Factorial
Treatments tested in this trial
CRIC
Devicechronic 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.
MFT
BehavioralParticipants 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 CIRC
DeviceThe pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as in the CIRC group.
sham MFT
BehavioralA 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 groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Incidence of MACE
Clinical events were defined as: cardiac death, nonfatal myocardial infarction, hospitalization for new heart failure,hospitalization for angina pectoris
Incidence of Cardiac Death
Death is considered cardiac unless there is clear evidence of non-cardiac death
Incidence of Non-fatal Myocardial Infarction
Includes STEMI and NSTEMI with elevated serum troponin on the basis of patient symptoms or ECG changes
Incidence of hospitalisation for new-onset heart failure
New onset of heart failure-related symptoms with elevated serum BNP or NT-ProBNP
Locations
Sponsors and contacts
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