NCT01366404招募中不适用
A Multicenter, Prospective Cohort to Evaluate the Natural History of FFR Guided Percutaneous Coronary Intervention
Seung-Jung Park29 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2011年6月1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
- 20,000
- 试验地点
- 29
- 主要终点
- composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events
研究概览
简要总结
About 20,000 patients with FFR (Fractional Flow Reserve) will be enrolled and evaluated for the natural history of coronary lesions at 2 years clinical and imaging follow-up.
详细描述
This is a multicenter, prospective cohort. About 20,000 patients with FFR will be enrolled at multi centres in Korea.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 35 years and older
- •FFR measurement on one and more coronary artery stenosis
- •Willing and able to provide informed, written consent
排除标准
- •Stenosis with TIMI<3 flow
- •Graft vessel
- •Ejection fraction < 30%
- •Angiographic evidence of extreme tortuosity or calcified coronary vessels
- •Suspected coronary spasm even after sufficient nitrate injected
- •Life expectancy <2 year
- •Planned cardiac surgery or planned major non cardiac surgery
- •Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study
- •Imaging study specific exclusion criteria
- •visually-estimated angiographic reference segment diameter of <2.75mm or >4.0mm
- •Inappropriate for IVUS/VH/OCT procedures : inability for imaging wire or catheter to pass through the tight stenosis, severe calcification, angulation
结局指标
主要结局
composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events
时间窗: at 2 year after index FFR measurement
Target vessel failure
时间窗: 2 year after index FFR measurement
次要结局
- stented lesion related event including death, myocardial infarction, repeat revascularization(2 year follow-up after index FFR measurement)
- change in IVUS-measured MLA(2 year follow-up after index FFR measurement)
- number of anti-anginal medication prescribed(2 year follow-up after index FFR measurement)
- change in FFR(2 year follow-up after index FFR measurement)
- Target lesion revascularization(at 2 year after index FFR measurement)
- Any re-hospitalization with a cardiac cause(2 year follow-up after index FFR measurement)
- cardiac death and myocardial infarction(2 year follow-up after index FFR measurement)
- complication of FFR measurement(2 year follow-up after index FFR measurement)
- Target vessel revascularization(at 2 year after index FFR measurement)
- anginal status(2 year follow-up after index FFR measurement)
- clinical predictors of events(2 year follow-up after index FFR measurement)
- change in plaque composition (%necrotic core volume) in target segment(2 year follow-up after index FFR measurement)
- change in plaque type assessed by VH(Virtual Histology) and OCT(Optical coherence tomography)(2 year follow-up after index FFR measurement)
- Death (all cause and cardiac)(at 2 year after index FFR measurement)
- MI(at 2 year after index FFR measurement)
- stroke(2 year follow-up after index FFR measurement)
- change in total atheroma volume and percent atheroma volume(2 year follow-up after index FFR measurement)
- stent thrombosis(2 year follow-up after index FFR measurement)
研究者
Seung-Jung Park
Professor, Division of Cardiology
CardioVascular Research Foundation, Korea
研究点 (29)
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