CTRI/2025/01/078948招募中不适用
A randomized trial of physiology-guided versus angiography-guided non-culprit lesion (NCL) complete revascularization strategies and a large-scale observational study of Optical Coherence Tomography in patients with acute myocardial infarction and multivessel coronary artery disease
Population Health Research Institute (PHRI)12 个研究点 分布在 1 个国家目标入组 5,100 人开始时间: 2025年1月31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
- 5,100
- 试验地点
- 12
- 主要终点
- Efficacy: Time to first occurrence of the composite of CV death, new MI or ischemia-driven revascularization (IDR).
研究概览
简要总结
In patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI):
- To determine whether a strategy of physiology-guided complete
revascularization is nonâ€inferior to a strategy of angiographyâ€guided
complete revascularization on the efficacy composite outcome of
cardiovascular (CV) death, new myocardial infarction (MI) or ischemiaâ€driven revascularization (IDR). If non-inferiority is established, superiority of the physiology-guided strategy will be tested.
- To determine whether a physiology-guided complete revascularization strategy is superior to an angiography-guided complete revascularization strategy in reducing the safety composite outcome of clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
- •Residual coronary artery disease defined as at least 1 additional non-infarct related coronary artery stenosis (ie, non-culprit lesion) that meets all of the following criteria: a) Amenable to successful treatment with PCI b) At least 50% diameter stenosis by visual estimation c) At least 2.5 mm in diameter
- •Planned complete revascularization strategy for qualifying myocardial infarction.
排除标准
- •Planned or prior coronary artery bypass graft (CABG) surgery
- •Inability to clearly identify a culprit lesion for index STEMI or NSTEMI based on angiographic appearance and/or ECG changes and/or regional wall motion abnormalities
- •Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
- •Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
- •Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow less than equal 2) or more than 90% visual diameter stenosis
- •Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion (patients with a CTO plus additional qualifying non-culprit lesions are eligible)
- •The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
- •Baseline STEMI or NSTEMI was due to a suspected non-atherothrombotic mechanism such as type 2 MI (supply-demand mismatch), e.g. spontaneous coronary artery dissection or coronary artery embolism
- •Non-cardiovascular co-morbidity with expected life expectancy less 2 years
- •Any other medical, geographic, or social factor (i.e., lack of access to transportation for clinical follow-up visits, inflexible schedule conflicting with follow-up visits) making study participation impractical or precluding 5 year follow-up.
结局指标
主要结局
Efficacy: Time to first occurrence of the composite of CV death, new MI or ischemia-driven revascularization (IDR).
时间窗: 5 Years
Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.
时间窗: 5 Years
次要结局
- 1. Time to first occurrence of the composite of CV death or new MI.(2. Net clinical outcome: Time to first occurrence of the composite of CV death, new MI, clinically significant bleeding, stroke, stent thrombosis or contrast associated)
研究者
Mr Jamnadas Kushwaha
Raptim Research Pvt. Ltd.
研究点 (12)
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