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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 40
View:

• 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

Locations
Other Locations
China
Department of Neurology, General Hospital of Northern Theater Command
RECRUITING
Shenyang
Time Frame
Start Date: 2025-11-19
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 2800
Treatments
RIC group
The patients will receive treatment with RIC (5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg, twice daily) for 1 year as an adjunct to guideline-based treatment
Control group
The patients will only receive guideline-based treatment
Related Therapeutic Areas
Sponsors
Leads: General Hospital of Shenyang Military Region

This content was sourced from clinicaltrials.gov