The Long-term Effect of Remote Ischemic Conditioning on Main Organs in ASVCD Patients With Very High Risks

NCT ID: NCT07270887

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-19
• Study Completion Date: 2027-12-30

Brief 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.

Conditions

ASCVD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

remote ischemic conditioning

Intervention Type: DEVICE

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

No interventions assigned to this group

Interventions

remote ischemic conditioning

5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Hui-Sheng Chen, Ph.D.

Role: primary

chszh@aliyun.com

+86 13352452086

Other Identifiers

Y (2025) 394

Identifier Type: -

Identifier Source: org_study_id