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临床试验/NCT03855436
NCT03855436Unknown不适用

Identify Intermediate Coronary Lesions at High Risk of Progression-Study Design and Protocol of a Prospective Observational Study

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 1,389 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,389
试验地点
1
主要终点
Major adverse cardiac events (MACE)

研究概览

简要总结

Coronary intermediate lesions generally refer to lumen narrowing with diameter stenosis% (DS%) between 50% and 70% on angiography. Prognosis varies significantly among patients with intermediate lesions, and some lesions progress rapidly leading to adverse cardiovascular events. Therefore, accurate risk stratification is important and will help clinicians identify patients at high risk of adverse events. The aim of study is to identify independent risk factors for major adverse cardiovascular events (MACE) among patients with intermediate lesions.

The study is a prospective, single-center, ongoing, observational study, which aims at enrolling approximately 1389 patients with intermediate coronary lesions. After enrollment, the following data are collected for each participant: baseline characteristics including demographics, clinical presentation, traditional risk factor, diagnosis and management; lesion characteristics assessed by coronary angiography; quantitative flow reserve; lab tests including blood chemistry, blood lipid, hemoglobin A1C, cardiac biomarker, BNP, et al. Patients are followed up at 2 year for primary outcome including death, myocardial infarction and repeat unplanned revascularization. A risk prediction score will be established and validated for major adverse cardiovascular disease at two-year follow-up.

详细描述

Study setting This ongoing study is conducted in Fuwai Hospital, one of the world's biggest cardiovascular center specializing in all kinds of cardiovascular diseases, particularly those complex, difficult, and severe cardiovascular diseases. More than 10000 angiographic procedures is performed each year in Fuwai Hospital.

Recruitment

From 2017 January 1st, all patients admitted to Fuwai Hospital receiving elective coronary angiography were screened for eligibility. Detailed inclusion and exclusion creteria are shown as follows:

Inclusion Criteria:

  1. Receiving elective coronary angiography.
  2. One or more lesions located in main coronary arteries with intermediate stenosis (defined as diameter stenosis of 50%-70%).
  3. No lesions with significant stenosis (greater than 70%)

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
是

入选标准

  • •Receiving elective coronary angiography
  • •Written informed consent
  • •One or more lesions located in main coronary arteries with intermediate stenosis (defined as diameter stenosis of 50%-70%)
  • •No lesions with significant stenosis (greater than 70%)

排除标准

  • •Unable to sign consent
  • •Receiving percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
  • •Planned PCI or CABG
  • •Left ventricle ejection fraction % (LVEF%)<35% or cardiogenic shock
  • •Other severe comorbidities with life expectancy <1 year

结局指标

主要结局

Major adverse cardiac events (MACE)

时间窗: 2 years

death, nonfatal myocardial infarction, repeat revascularization

次要结局

未报告次要终点

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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