Intracoronary Cocktail Injection Improves Outcomes of Fractional Flow Reserve Guided Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrom (ACS)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events
研究概览
简要总结
This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS).
详细描述
This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). Patients with ACS will be randomized into the cocktail plus FFR guided group or the QCA guided group. The primary outcome of the cocktail II study is the composite of death, myocardial infarction, class IV heart failure and target vessel revascularization within 1 year. The secondary outcome of the cocktail II study include left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a clinical diagnosis of recent ACS within 5 days
排除标准
- •haemodynamic instability
- •intolerance to anti-platelet drugs
- •ineligible for coronary revascularization
- •a treatment plan for non-coronary heart surgery (e.g. valve surgery)
- •a history of prior PCI or CABG
- •angiographic evidence of severe (e.g. diffuse calcification) or mild (<30% severity) coronary disease
- •a life expectancy less than 1 year
- •adenosine allergy
研究组 & 干预措施
Cocktail plus FFR guided group
Intracoronary cocktail injection before fractional flow reserve (FFR) measurement. Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).
干预措施: cocktail (Drug)
Cocktail plus FFR guided group
Intracoronary cocktail injection before fractional flow reserve (FFR) measurement. Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).
干预措施: FFR (Device)
QCA guided group
Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS).
干预措施: QCA guided group (Device)
结局指标
主要结局
Major adverse cardiac events
时间窗: 1 year
number of participants with death, myocardial infarction or class IV heart failure and target vessel revascularization revascularization
次要结局
- stroke(1 year)
- Seattle Angina Questionnaire scores(1 year)
- left ventricular function(1 year)
- Canadian Cardiovascular Society (CCS) Functional Angina classification(1 year)
- 6-minute walk distance (6MWD)(1 year)
研究者
sunddong
Principal Investigator
Xijing Hospital