QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Patient-oriented combined endpoint (clinical endpoint)
研究概览
简要总结
The aim of this study is to study whether the use of complex 3-dimensional assessment of the severity of a stenosis improves angina and in general cardiovascular outcomes in patients who have residual intermediate coronary artery stenosis following an acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI).
Goals of the study are:
- To investigate whether decision-making based on quantitative flow reserve (QFR) is associated with a decrease in angina 3 months after an ACS
- To investigate whether use of QFR is associated with an improved prognosis.
详细描述
The study is a single-center, randomized superiority trial to compare two strategies for the assessment of the hemodynamic relevance of coronary lesions.
The primary analysis will be on the per-protocol principle (i.e. including all patients who are not protocol violators). A separate analysis will be performed on an intention-to-treat basis (i.e. all randomized patients randomized to a treatment arm).
Primary endpoint 1. Angina questionnaire
Secondary endpoints:
Number and % of patients undergoing PCI
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)
盲法说明
Patients and outcome assessors will be blinded to the randomization group.
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
- •Successfully treated acute coronary syndrome
- •At least one additional intermediate stenosis (>30% and <90%).
- •Patient ≥18 years old
排除标准
- •Stenoses or patients a priori not amenable to treatment with PCI (at the discretion of two interventional cardiologists - e.g. patients with limited life expectancy, stenosis in very small vessels, very diffuse disease with complex/very calcified stenosis requiring surgery etc).
- •Persistent symptoms or evidence of ischemia requiring intervention of the non-culprit lesion.
- •Any contraindication to PCI according to guidelines
- •An ACS in the period following the index ACS and randomization
- •TIMI (Thrombolysis in Myocardial Infarction) flow grade < 3 in the culprit vessel
- •Presence of thrombus in the non-culprit lesion
- •Participation in another randomized interventional study interfering with the present protocol
- •Patient unable to give informed consent
- •Women of child-bearing potential or lactating
- •Previous coronary artery bypass surgery CABG
- •Recent (within 30 days) unsuccessful PCI
- •Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months
- •Left ventricular ejection fraction <30%
- •Severe chronic obstructive pulmonary disease (COPD)
- •Severe valvular heart disease
- •FFR (or RFR, iFR etc) assessment of non-culprit lesions at the time of the index procedure
结局指标
主要结局
Patient-oriented combined endpoint (clinical endpoint)
时间窗: 12 months
composite of patient-oriented events and significant angina (all-cause death, non fatal myocardial infarction including type 1, 2, 4, unplanned hospitalization for angina or heart failure, unplanned revascularization, SAQ\<90)
Functional endpoint
时间窗: Upon randomization and following QFR assessment
Proportion of patients assigned to medical treatment in the two groups (QFR vs. Reference)
次要结局
- Seattle angina questionaire summary score(3 months)
- Unplanned admission(12 months)
- Patient-oriented composite endpoint(12 months)
研究者
Tommaso Gori
Clinical Professor
Johannes Gutenberg University Mainz