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

NCT06820970 | Recruiting DMC

• 1 other identifier: HenanICE202501
• Study Type: interventional
• Target: 3,420
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of MACE

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

  12 months

Secondary Outcomes (12)

• Incidence of Cardiac Death

  3，6，9，12，24months

• Incidence of Non-fatal Myocardial Infarction

  3，6，9，12，24months

• Incidence of hospitalisation for new-onset heart failure

  3，6，9，12，24months

• Incidence of hospitalised for angina pectoris

  3，6，9，12，24months

• Incidence of unplanned revascularisation

  3，6，9，12，24months

Study Arms (4)

CRIC+MFT

EXPERIMENTAL

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.

Device: chronic remote ischemic conditioning; Behavioral: Mindfulness Therapy

Control (neither CRIC nor MFT).

SHAM COMPARATOR

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).

Other: sham CRIC; Behavioral: sham MFT

CRIC+sham MFT

SHAM COMPARATOR

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).

Device: chronic remote ischemic conditioning; Behavioral: sham MFT

Sham CRIC+MFT

SHAM COMPARATOR

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.

Behavioral: Mindfulness Therapy; Other: sham CRIC

Interventions

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.

Also known as: CRIC

CRIC+MFT; CRIC+sham MFT

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.

Also known as: MFT

CRIC+MFT; Sham CRIC+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.

Control (neither CRIC nor MFT).; Sham CRIC+MFT

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).

CRIC+sham MFT; Control (neither CRIC nor MFT).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.);

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Muwei LI, MD

  Fuwai Central China of Cardiovascular Hospital

  STUDY CHAIR

Central Study Contacts

Quan Guo, MD

CONTACT

15670510031; xinyiguoquan@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study adopts a 2×2 factorial randomized controlled trial design to evaluate the independent and combined effects of chronic remote ischemic preconditioning (CRIC) and mindfulness therapy (MFT) on anxiety and sleep quality in patients with coronary heart disease. Participants will be randomly assigned to one of four groups: (1) CRIC plus MFT, (2) CRIC only, (3) MFT only, or (4) neither intervention (control). The design allows the assessment of the main effects of RIPC and MBT, as well as the potential interaction effect between the two interventions.

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Main research content 2 years after the publication of the paper
• Access Criteria: It is available on reasonable request from the contact person for the study

Locations

CN (1)