Long-term remote ischemic conditioning to protect the heart, brain, and kidneys in very-high-risk ASCVD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Neurology, General Hospital of Northern Theater Command
  Shenyang, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.