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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,800
- 试验地点
- 1
- 主要终点
- Incidence of Composite Endpoint Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
排除标准
- •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.
结局指标
主要结局
Incidence of Composite Endpoint Events
时间窗: 1 year
including cardiovascular events, stroke, vascular death, and deterioration of renal function.
次要结局
- Occurence of vascular death(1 year)
- Barthel Index (BI) scores(1 year)
- Death due to all causes(1 year)
- Number of participants with no-fatal cardiovascular events(1 year)
- Number of participants with new onset diabetes(1 year)
- Number of participants with no-fatal stroke(1 year)
- Change of renal function(1 year)
- Change of blood pressure(1 year)
- Number of participants with no-fatal deterioration of renal function(1 year)
- Changes in serological indicators such as blood glucose, blood lipids, and glycated hemoglobin (HbA1c)(1 year)
研究者
Hui-Sheng Chen
Director
General Hospital of Shenyang Military Region