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临床试验/NCT07766434
NCT07766434招募中不适用

A Prospective Multicenter Real-World Registry of Quantitative Flow Ratio-Guided Coronary REvascularization and QuAlity evaLuation

China National Center for Cardiovascular Diseases2 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2026年8月26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
10,000
试验地点
2
主要终点
QFR Adoption Rate

研究概览

简要总结

This prospective, multicenter observational registry aims to establish a QFR-based quality control standard system for coronary revascularization in patients with coronary artery disease. The study will enroll over 10,000 patients with visually estimated at least one main branch coronary stenosis ≥50% from more than 50 centers across China (covering provincial, municipal, and county-level hospitals). Coronary angiographic images and intracoronary imaging (if available) will be collected and retrospectively analyzed by an independent core laboratory. The primary endpoint is QFR acquisition accessibility, defined as the mean of QFR usage proportion across centers.

详细描述

This is a prospective, multicenter, observational registry study conducted at more than 50 centers across China. Patients with coronary angiography showing visually estimated at least one main branch stenosis ≥50% who undergo PCI or receive conservative treatment for acute coronary syndrome (including unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction >4 weeks after onset) or chronic coronary syndrome (including stable angina and asymptomatic myocardial ischemia) will be consecutively enrolled. Coronary angiographic images will be submitted to an independent core laboratory for retrospective QFR analysis. The study will establish a QFR-based quality control standard system for coronary revascularization.

Prespecified subgroup analyses will be performed to assess the concordance rates, overtreatment, and undertreatment rates between clinical decisions and offline core laboratory QFR, and to explore heterogeneity across hospital levels, clinical presentations, disease complexity, target vessel, operator annual PCI volume, QFR image analyzability, and lesion morphology. Other prespecified subgroups will be analyzed for the primary and secondary endpoints, including age, sex, diabetes, smoking status, acute coronary syndrome, body mass index, left ventricular ejection fraction, lesion location, length and reference vessel diameter, stenosis severity, multivessel disease, calcified lesion, bifurcation, tandem and bending/tortuous lesion, QFR gray zone (0.75-0.85), QFR based functional and residual functional SYNTAX score, residual QFR, center experience for invasive physiology, and learning experience with QFR.

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
  • •Coronary angiography showing visually estimated at least one main branch coronary stenosis ≥50% in patients with acute coronary syndrome (including unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction >4 weeks after onset) or chronic coronary syndrome (including stable angina and asymptomatic myocardial ischemia) who undergo PCI or receive conservative treatment
  • •Ability to understand the study design and provide written informed consent

排除标准

  • •ST-segment elevation myocardial infarction within 4 weeks of onset
  • •History of coronary artery bypass grafting (CABG) or planned CABG within 6 months
  • •Inability to undergo coronary angiography
  • •Non-cardiac cause with expected survival <1 year
  • •Other conditions that may interfere with follow-up (e.g., dementia, substance abuse including drug addiction and other drug dependencies)
  • •Refusal to participate in the study

结局指标

主要结局

QFR Adoption Rate

时间窗: At enrollment (baseline)

Defined as the mean across participating centers of the proportion of patients undergoing QFR assessment among eligible patients at each center.

次要结局

  • MI(6 months, 1 year, 3 years, and 5 years)
  • Target vessel revascularization (TVR)(6 months, 1 year, 3 years, and 5 years)
  • MACE(6 month, 1 year, 3 years, and 5 years)
  • Death(6 months, 1 year, 3 years, and 5 years)
  • Any coronary artery revascularization(6 months, 1 year, 3 years, and 5 years)
  • Definite or probable stent thrombosis(6 months, 1 year, 3 years, and 5 years)

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 (2)

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