KCT0006406招募中未知
OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON for Non-Infarct Related Artery in Non-ST-Segment Elevation Myocardial Infarction with Multivessel Disease (OPTION-NSTEMI)
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 676
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit(—)
- 性别
- All
入选标准
- •1) Age = 19 years old
- •2) Non-ST-segment elevation myocardial infarction
- •** Angina pectoris or equivalent ischemic chest discomfort with at least 1 of 3 features and,
- •# occurs at rest, usually lasting > 10 minutes
- •# severe and new onset (within the prior 4-6 weeks)
- •# crescendo pattern
- •** Elevated cardiac biomarkers and,
- •# = 99% value of high-sensitivity cardiac troponin
- •** No ST-segment elevation = 0.1 mV in = 2 contiguous leads or newly developed left bundle branch block on 12-lead electrocardiogram
- •3) PCI within 72 hours after symptom development
- •4) Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation
- •5) Patient's or protector's agreement about study design and the risk of PCI
排除标准
- •1) Cardiogenic shock at initial presentation or after treatment of infarct-related artery(IRA)*
- •2) Thrombolysis in Myocardial Infarction(TIMI) flow at non-IRA = 2 at initial coronary angiography
- •3) Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision
- •4) Non-IRA lesion not suitable for percutaneous coronary intervention(PCI) treatment by operators' decision
- •5) Chronic total occlusion at non-IRA
- •6) History of anaphylaxis to contrast agent
- •7) Pregnancy and lactation
- •8) Life expectancy < 1-year due to non-cardiac disease
- •9) Severe valvular disease
- •10) History of coronary artery bypass graft(CABG), or planned CABG
- •11) Severe asthma
- •12) Patient's refusal for study participation
- •* The definition of cardiogenic shock
- •1) Systolic blood pressure(SBP) < 90mmHg for more than 30min, or needs for vasopressor to maintain equal or more than SBP 90mmHg
- •2) Pulmonary congestion, or increased left ventricular filling pressure by cardiac catheterization
- •3) At least one sign of impaired organ perfusion: mental obtundation, pallor, coldness, oliguria, increased blood lactate
研究者
相似试验
进行中(未招募)
不适用
OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON in ST-Segment Elevation Myocardial InfarctioKCT0004457Chonnam National University Hospital994
已完成
不适用
The Effectiveness of Fractional Flow Reserve, Coronary Flow Reserve and the Index of Micro-circulatory resistance in Patients with Hemodialysis.Hemodialysis patients with intermediate coronary artery stenosisJPRN-UMIN000029790Shonan Kamakura General Hospital100
已完成
4 期
To understand the routine use of fractional flow reserve procedure in patients with coronary artery disease.CTRI/2018/04/013104ST JUDE MEDICAL India Pvt Ltd97
招募中
不适用
Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR guided revascularizatioIntermediate coronary artery stenosis10011082NL-OMON54348European Cardiovascular Research Institute800
尚未招募
Unknown
A Comparison of Fractional Flow Reserve- versus Angiography-Guided Percutaneous Coronary Intervention in Patients with Left Main Coronary Artery DiseaseDiseases of the circulatory systemKCT0009073Asan Medical Center934
