Combining chronic remote ischemic conditioning and mindfulness to lower heart events after incomplete coronary revascularization

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

This will test whether adding periodic remote ischemic conditioning and mindfulness therapy can reduce heart-related events in people with coronary artery disease who have incomplete revascularization.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Henan Institute of Cardiovascular Epidemiology (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06820970 on ClinicalTrials.gov

What this trial studies

This interventional study tests whether combining chronic remote ischemic conditioning (CRIC) with mindfulness therapy (MFT) reduces cardiovascular adverse events in patients with incomplete coronary revascularization. Participants receive active or sham versions of CRIC and MFT and are followed for heart-related outcomes and symptoms. Eligible adults have coronary artery disease with at least one vessel showing >90% stenosis and a QFR < 0.80 plus ischemic symptoms. The trial is run at Fuwai Central China Cardiovascular Hospital in Zhengzhou, Henan.

Who should consider this trial

Good fit: Adults (≥18 years) with coronary artery disease who have incomplete revascularization (≥1 vessel with >90% stenosis and QFR <0.80) and ongoing signs or symptoms of myocardial ischemia are ideal candidates.

Not a fit: Patients with severe heart failure (NYHA class IV or LVEF <30%), end-stage renal disease or dialysis dependence, primary myocardial diseases, or uncontrolled/recurrent serious arrhythmias are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could lower the risk of future heart attacks, hospitalizations, or other cardiovascular events and improve ischemic symptoms.

How similar studies have performed: Previous studies of remote ischemic conditioning and mindfulness separately have shown mixed or modest effects on cardiovascular outcomes and symptoms, and combining the two is a relatively novel approach.

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.

Where this trial is running

Zhengzhou, Henan

• Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Study coordinator: Quan Guo, MD

Conditions Coronary Artery Disease