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

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.

Study Overview

• Status: Recruiting
• Conditions: ASCVD
• Intervention / Treatment: Device: remote ischemic conditioning

• Study Type: Observational
• Enrollment (Estimated): 2800

Contacts and Locations

Study Locations

• China
  • Shenyang, China, 110016
    • Recruiting
    • Department of Neurology, General Hospital of Northern Theater Command
    • Contact: Hui-Sheng Chen, Ph.D.; Phone Number: +86 13352452086; Email: chszh@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

very high-risk ASCVD populations

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: remote ischemic conditioning; 5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg
Control group; The patients will only receive guideline-based treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Composite Endpoint Events	including cardiovascular events, stroke, vascular death, and deterioration of renal function.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with no-fatal cardiovascular events		1 year
Number of participants with no-fatal stroke		1 year
Number of participants with no-fatal deterioration of renal function		1 year
Change of renal function	renal function was meausred by serum urea nitrogen and creatinine	1 year
Change of blood pressure		1 year
Changes in serological indicators such as blood glucose, blood lipids, and glycated hemoglobin (HbA1c)	Changes in the following serological indicators will be assessed and reported as separate outcome measures: Blood glucose (in mmol/L or mg/dL) Blood lipids [specify component, e.g., LDL-C, in mmol/L or mg/dL] Glycated hemoglobin (HbA1c) (in %)	1 year
Number of participants with new onset diabetes		1 year
Occurence of vascular death		1 year
Barthel Index (BI) scores	BI ranges from 0-100, higher scores meaning a better outcome.	1 year
Death due to all causes		1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cerebral small vessel disease burden (CSVD)	The total CSVD score is calculated by the following four neuroimaging features on MRI: lacunes, white matter hyperintensities, cerebral microbleeds and perivascular spaces (PVS). The score ranges from 0-4, with high score meaning heavier burden.	1 year
Changes in cognitive function measured by MoCA and MMSE	The Montreal Cognitive Assessment (MoCA) (score range: 0-30) and The Mini-Mental State Examination (MMSE) (score range: 0-30), with higher score meaning better cognitive function	1 year
Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)	range from 0-27, higher score meaning worse symptoms	1 year
Anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7)	range from 0-21, higher score meaning worse symptoms	1 year
Changes in cerebral autoregulation	cerebral autoregulation is measured by using TCD and Transfer Function Analysis	1 year

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Y (2025) 394

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No