Menu
Recruiting NCT07270887

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

— Observational ASCVD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: remote ischemic conditioning.
Who it may be relevant to
Registry conditions: ASCVD. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Incidence of Composite Endpoint Events [Time frame: 1 year]
Secondary outcome measures (10)
  • Number of participants with no-fatal cardiovascular events [Time frame: 1 year]
  • Number of participants with no-fatal stroke [Time frame: 1 year]
  • Number of participants with no-fatal deterioration of renal function [Time frame: 1 year]
  • Change of renal function [Time frame: 1 year]
  • Change of blood pressure [Time frame: 1 year]
  • Changes in serological indicators such as blood glucose, blood lipids, and glycated hemoglobin (HbA1c) [Time frame: 1 year]
  • Number of participants with new onset diabetes [Time frame: 1 year]
  • Occurence of vascular death [Time frame: 1 year]
  • Barthel Index (BI) scores [Time frame: 1 year]
  • Death due to all causes [Time frame: 1 year]

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:

  • 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Neurology, General Hospital of Northern Theater Command — Shenyang

Identifiers

NCT: NCT07270887 · Y (2025) 394

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗