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NCT Number: NCT07270887

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

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.

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Key information

Conditions

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Location status: Recruiting

Location contact

Hui-Sheng Chen, Ph.D.

CONTACT

[email protected]

+86 13352452086

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Incidence of Composite Endpoint Events

    Time frame: 1 year

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

Secondary outcomes

  1. Number of participants with no-fatal cardiovascular events

    Time frame: 1 year

  2. Number of participants with no-fatal stroke

    Time frame: 1 year

  3. Number of participants with no-fatal deterioration of renal function

    Time frame: 1 year

  4. Change of renal function

    Time frame: 1 year

    renal function was meausred by serum urea nitrogen and creatinine

  5. Change of blood pressure

    Time frame: 1 year

  6. Changes in serological indicators such as blood glucose, blood lipids, and glycated hemoglobin (HbA1c)

    Time frame: 1 year

    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 %)

  7. Number of participants with new onset diabetes

    Time frame: 1 year

  8. Occurence of vascular death

    Time frame: 1 year

  9. Barthel Index (BI) scores

    Time frame: 1 year

    BI ranges from 0-100, higher scores meaning a better outcome.

  10. Death due to all causes

    Time frame: 1 year

Other outcomes

  1. Changes in cerebral small vessel disease burden (CSVD)

    Time frame: 1 year

    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.

  2. Changes in cognitive function measured by MoCA and MMSE

    Time frame: 1 year

    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

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

    Time frame: 1 year

    range from 0-27, higher score meaning worse symptoms

  4. Anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 1 year

    range from 0-21, higher score meaning worse symptoms

  5. Changes in cerebral autoregulation

    Time frame: 1 year

    cerebral autoregulation is measured by using TCD and Transfer Function Analysis

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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