RecruitingNCT07270887

The Long-term Effect of Remote Ischemic Conditioning on Main Organs in ASVCD Patients With Very High Risks

The Long-term Effect of Remote Ischemic Conditioning on Main Organs in ASVCD Patients With Very High Risks (RICMO-ASCVD): a Prospective, Blinded Endpoint, Multi-center, Cohort Study

Sponsor

General Hospital of Shenyang Military Region

Enrollment

2,800 participants

Start Date

Nov 19, 2025

Study Type

OBSERVATIONAL

Conditions

ASCVD

Summary

Atherosclerotic cardiovascular disease (ASCVD) is a group of disorders sharing atherosclerosis as a common pathological basis, primarily affecting the heart, brain, kidneys, and other peripheral arteries, leading to clinical syndromes characterized mainly by arterial ischemia. It has become the group of diseases with the highest morbidity and mortality rates worldwide. Patients with very high-risk ASCVD face an even greater risk of recurrence. Previous studies have discovered that remote ischemic conditioning (RIC) has protective effects on major organs such as the heart, brain, and kidneys. Given the cardiorenal and cerebrovascular protective effects of RIC, the invesitgators believe that long-term remote ischemic conditioning is a promising approach to preventing the recurrence of ASCVD events. Based on this hypothesis, the investigators have designed a prospective, multicenter cohort study with blinded outcome assessment to investigate the protective effects of long-term remote ischemic conditioning in very high-risk ASCVD populations.

Eligibility

Min Age: 40 Years

Inclusion Criteria17

Age over 40 years
Two or more prior major ASCVD events; OR one documented major ASCVD event with two or more of the following risk factors
signed informed consent
Note： Definition of Major ASCVD Events:
A. Acute coronary syndrome within the past year. B. History of myocardial infarction (not part of a new acute coronary syndrome episode).
C. Ischemic stroke or history of ischemic stroke. D. Symptomatic peripheral artery disease, defined as intermittent claudication with an ankle-brachial index (ABI) \< 0.85, or prior limb revascularization or amputation.
Risk factors:
Age ≥65 y
Heterozygous familial hypercholesterolemia
History of prior coronary artery bypass surgery or percutaneous coronary intervention outside of the major
ASCVD event(s)
Diabetes mellitus
Hypertension
CKD (eGFR 15-59 mL/min/1.73 m2)
Current smoking
Persistently elevated LDL-C (LDL-C ≥100 mg/dL \[≥2.6 mmol/L\]) despite maximally tolerated statin therapy and ezetimibe
History of congestive HF

Exclusion Criteria8

Presence of severe neurological deficit (mRS score ≥ 3)
Uncontrolled severe hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg despite medication)
Subclavian artery stenosis ≥ 50% or presence of subclavian steal syndrome
Severe hematological disorders or significant coagulation abnormalities
Contraindications to remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limbs, or peripheral vascular disease in the distal upper limbs
Severe comorbid conditions with a life expectancy of less than 1 year
Participation in another clinical trial within the past 3 months or ongoing participation
Any other circumstances deemed by the investigator as unsuitable for participation in this clinical study.

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