NCT05437965招募中不适用
National Multicenter Cohort Registry Study of Rapid rEcurrences of Coronary Unexplained In-stent Restenosis
China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年6月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Target vessel failure
研究概览
简要总结
This project aims to establish a clinical cohort and diagnostic assessment framework by conducting a national multicenter cohort registry study. Through the collection of patients' clinical characteristics, it will achieve the registration, management, follow-up, and analysis of patients with Rapid rEcurrences of Coronary Unexplained in-stent Restenosis (RECUR).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Patients meeting the diagnostic criteria for Rapid rEcurrences of Coronary Unexplained in-stent Restenosis (RECUR);
- •Patients fully informed about the trial procedures who provide written informed consent.
排除标准
- •Patients presenting with any of the following:
- •Other severe comorbidities (e.g., malignant tumors, heart failure) with a life expectancy <12 months;
- •Known autoimmune/rheumatic diseases including systemic lupus erythematosus, Takayasu arteritis, Behçet's disease, polyarteritis nodosa, Wegener granulomatosis (granulomatosis with polyangiitis), eosinophilic arteritis, giant cell arteritis, rheumatoid arthritis, or IgG4-related disease;
- •Variant angina (Prinzmetal's angina);
- •Coronary artery dissection;
- •Thrombophilia;
- •Stent underexpansion.
- •Presence of psychiatric disorders;
- •Known inability to complete expected study follow-up for any reason;
- •Patients deemed ineligible for enrollment by the investigator.
结局指标
主要结局
Target vessel failure
时间窗: 10 year
Time to the incidence of target vessel failure, a composite of cardiovascular death, target vessel-related myocardial infarction, and target vessel-related revascularization.
次要结局
未报告次要终点
研究者
Kefei Dou, MD
Director of the Department of Internal Medicine
China National Center for Cardiovascular Diseases
研究点 (1)
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