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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
Led by General Hospital of Shenyang Military Region · Updated on 2025-12-08
2800
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying atherosclerotic cardiovascular disease (ASCVD), a group of disorders caused by atherosclerosis that mainly affect the heart, brain, kidneys, and other arteries, leading to artery blockages. This condition has the highest rates of illness and death worldwide, especially in patients with very high-risk ASCVD who face a greater chance of recurrence. The study evaluates the long-term protective effects of remote ischemic conditioning (RIC) on major organs in this high-risk group through a prospective, multicenter cohort study with blinded outcome assessment. The study compares two groups: one group will receive RIC treatment involving 5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes on both upper limbs at 200 mmHg, twice daily for one year, alongside guideline-based treatment. The other group will receive only guideline-based treatment without RIC. RIC is being assessed as an additional therapy to protect the heart, brain, and kidneys and prevent ASCVD event recurrence. Participants will be monitored over one year, with researchers tracking the incidence of composite endpoint events such as cardiovascular events, strokes, kidney function changes, blood pressure, blood glucose, blood lipids, new diabetes onset, vascular death, and overall mortality. Assessments include serological tests and functional scores like the Barthel Index. Safety and outcomes will be observed during this period to understand the effects of long-term RIC in very high-risk ASCVD patients.
CONDITIONS
Brief Title
The Long-term Effect of Remote Ischemic Conditioning on Main Organs in ASVCD Patients With Very High Risks
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 40 years
- Two or more prior major ASCVD events; OR one major ASCVD event plus two or more risk factors
- Signed informed consent
You will not qualify if you...
- Severe neurological deficits with modified Rankin Scale score 3 or higher
- Uncontrolled severe hypertension (systolic > 180 mmHg or diastolic > 110 mmHg despite medication)
- Subclavian artery stenosis 50% or more or subclavian steal syndrome
- Severe blood disorders or major coagulation problems
- Contraindications to remote ischemic conditioning such as severe upper limb injury or peripheral vascular disease in the arms
- Severe other illnesses with life expectancy less than 1 year
- Participation in another clinical trial within the past 3 months or ongoing
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants in the RIC group receive remote ischemic conditioning consisting of 5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes on both upper limbs twice daily for 1 year as an adjunct to guideline-based treatment. Participants in the control group continue with guideline-based treatment alone.
Regular visits as part of routine healthcare
Duration - 1 year
Participants are observed for cardiovascular events, renal function changes, blood pressure, serological indicators, and overall health status for 1 year.
Periodic assessments during routine visits
Trial Site Locations
Total: 1 location
1
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China, 110016
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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