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

NCT07270887 | Recruiting DMC

• 1 other identifier: Y (2025) 394
• Study Type: observational
• Target: 2,800
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Composite Endpoint Events

  including cardiovascular events, stroke, vascular death, and deterioration of renal function.

  1 year

Secondary Outcomes (10)

• 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

  1 year

• Change of blood pressure

  1 year

Other Outcomes (5)

• Changes in cerebral small vessel disease burden (CSVD)

  1 year

• Changes in cognitive function measured by MoCA and MMSE

  1 year

• Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)

  1 year

Study Arms (2)

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

Control group

The patients will only receive guideline-based treatment

Interventions

remote ischemic conditioning DEVICE

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

RIC group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

very high-risk ASCVD populations

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 8, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-11

Locations

CN (1)