Characterization of Coronary Artery Hemodynamic Measurements and Virtual Angioplasty Planning by Instantaneous Wave-free Ratio (iFR) in Multivessel Acute Coronary Syndrome Patients With Evaluation of the Impact on Clinical Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- PCI-related Major adverse cardiac events (MACE)
研究概览
简要总结
A single-center, prospective, randomized, open-label, blinded end-point clinical trial of instantaneous wave-free ratio (iFR) guidance strategy impact on clinical outcomes in multivessel acute coronary syndrome (ACS) patients.
详细描述
The "all-comers" study population consists of hemodynamically stable de novo ACS patients with a stenosis of 50% and more by visual estimation in at least two separate coronary arteries with Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 2 and willing to sign a patient informed consent. ACS diagnosis established by angina pectoris symptoms and/or ECG changes and/or hs-troponin I levels. The use of drug-eluting stents is mandatory in both treatment groups. In the intervention strategy group, patients are treated by the iFR-guided percutaneous coronary intervention (PCI) in one stage. In the control group, patients are treated in accordance with the standard practice of angiography-guided staged approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •18 years of age and older
- •willing to give informed consent
- •hemodynamically stable de novo acute coronary syndrome patients with a stenosis of 50% and more by visual estimation in at least two separate coronary arteries
- •adequate coronary flow, Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 2
- •sinus rhythm
排除标准
- •inability to give consent;
- •younger than 18 years of age
- •atrial fibrillation rhythm at the time of inclusion
- •with significant valve disease
- •in cardiogenic shock
- •with reduced kidney function - eGFR < 30 (mL/min/1.73m2);
- •with congenital heart defects
- •with acute pulmonary artery embolism;
- •with isolated left main ostial stenosis;
- •on active oncologic treatment or toxic cardiomyopathy;
- •revascularization by PCI is not possible due to other comorbidities or patient denial of treatment.
结局指标
主要结局
PCI-related Major adverse cardiac events (MACE)
时间窗: 12 months
Composite of cardiac death, non-fatal myocardial infarction, unplanned revascularization, stent thrombosis, flow limiting coronary dissections, no-reflow phenomenon, coronary perforations, coronary distal embolization, vascular access site complications requiring blood transfusion or surgical intervention and contrast-induced nephropathy requiring hospitalisation.
次要结局
- Segmental myocardial deformation by speckle-tracking echocardiography(Index admission, 3 months and 12 months)
- Health-related Quality of Life(Index admission, 3 months and 12 months)
- Number of Participants with Decline of eGFR(Index admission, 3 months and 12 months)
研究者
Deniss Vasiljevs
Principal Investigator
Daugavpils Regional Hospital