CRIC Combined With MFT for MFR in Patients With Incomplete Revascularization of CAD

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenan Institute of Cardiovascular Epidemiology

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 volunteers

Qualifiers

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

Design model

Factorial

Treatments tested in this trial

  • CRIC

    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.

  • MFT

    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.

  • sham CIRC

    Device

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

  • sham MFT

    Behavioral

    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 groups

480 Participants
are divided into 4 treatment groups
Group A: CRIC+MFTExperimental treatment 2 interventions
Group B: Control (neither CRIC nor MFT).Sham comparator 2 interventions
Group C: CRIC+sham MFTSham comparator 2 interventions
Group D: sham CRIC+MFTSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months

Secondary outcomes

1

Incidence of MACE

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

Time frame
3,6,9,12,24months
2

Incidence of Cardiac Death

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

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

Incidence of Non-fatal Myocardial Infarction

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

Time frame
3,6,9,12,24months
4

Incidence of hospitalisation for new-onset heart failure

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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