Long-term remote ischemic conditioning to protect the heart, brain, and kidneys in very-high-risk ASCVD
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
We will try regular remote ischemic conditioning to see if it protects the heart, brain, and kidneys in adults over 40 with very-high-risk ASCVD.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2800 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | General Hospital of Shenyang Military Region Academic / other |
| Locations | 1 site (Shenyang) |
| Trial ID | NCT07270887 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter cohort study with blinded outcome assessment testing long-term remote ischemic conditioning (RIC) in patients with very-high-risk atherosclerotic cardiovascular disease (ASCVD). Eligible participants are adults over 40 with either two or more prior major ASCVD events or one major event plus multiple high-risk features. Participants will undergo a program of repeated RIC and be followed over time for organ-specific outcomes in the heart, brain, and kidneys. The primary goal is to determine whether chronic RIC reduces recurrent ASCVD events and preserves organ function compared with expected outcomes in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are adults older than 40 with very-high-risk ASCVD defined by two or more prior major ASCVD events or one major event plus multiple specified risk factors who can give informed consent.
Not a fit: Patients without ASCVD, those at lower cardiovascular risk, or individuals unable to tolerate limb ischemia procedures (for example due to severe peripheral artery disease) are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, long-term RIC could reduce recurrent ASCVD events and protect heart, brain, and kidney function in very-high-risk patients.
How similar studies have performed: Prior small clinical trials and animal studies have shown short-term organ-protective effects of RIC, but long-term prevention of ASCVD recurrence in very-high-risk patients remains unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: 1. Age ≥65 y 2. Heterozygous familial hypercholesterolemia 3. History of prior coronary artery bypass surgery or percutaneous coronary intervention outside of the major 4. ASCVD event(s) 5. Diabetes mellitus 6. Hypertension 7. CKD (eGFR 15-59 mL/min/1.73 m2) 8. Current smoking 9. Persistently elevated LDL-C (LDL-C ≥100 mg/dL \[≥2.6 mmol/L\]) despite maximally tolerated statin therapy and ezetimibe 10. History of congestive HF Exclusion Criteria: * 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.
Where this trial is running
Shenyang
- Department of Neurology, General Hospital of Northern Theater Command — Shenyang, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.