Clinical trial NCT06820970: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 3420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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) \< 40%
* Creatinine clearance \< 30 mL/min (or eGFR \< 30 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.

Primary outcomes:
measure: MACE
timeFrame: 12 months
Secondary outcomes:
measure: Cardiac death
timeFrame: 3，6，9，12months
measure: Non-fatal myocardial infarction
timeFrame: 3，6，9，12months
measure: Hospitalisation for new-onset heart failure
timeFrame: 3，6，9，12months
measure: Hospitalised for angina pectoris
timeFrame: 3，6，9，12months
measure: Unplanned revascularisation
timeFrame: 3，6，9，12months
measure: All cause death
timeFrame: 3，6，9，12months
measure: Total length of hospitalization due to coronary heart disease
timeFrame: 3，6，9，12months
measure: Medical expenses due to coronary heart disease
timeFrame: 3，6，9，12months
measure: Degree of improvement in angina symptoms
timeFrame: 3，6，9，12months
measure: Change in anxiety scores
timeFrame: 3，6，9，12months
measure: Change in depression scores
timeFrame: 3，6，9，12months
measure: Changes in sleep quality
timeFrame: 3，6，9，12months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
state: Henan
Study officials:
affiliation: Fuwai Central China of Cardiovascular Hospital
name: Muwei LI, MD
role: STUDY_CHAIR
References: