NCT05967663招募中不适用
Fractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- MACCE
研究概览
简要总结
It is a prospective, multicenter, randomised controlled, open-label, blinded endpoint assessment trial, to compare the strategy of immediate complete revascularisation and staged complete revascularisation in ST-segment-elevation myocardial infarction patients with multivessel coronary disease.
详细描述
Objectives: The purpose of this study is to investigate whether FFR guided PCI strategy for non-culprit lesions should be attempted during the index procedure or staged in ST-segment-elevation myocardial infarction patients with multivessel coronary disease.
Inclusion Criteria:
- Age ≥ 18 years
- Patients presenting STEMI and multivessel coronary disease successful primary PCI of the culprit lesion (including those who still have ischemic symptoms within 48 hours)
- Multivessel disease was defined at least one non-culprit coronary arteries with a diameter of 2.5 mm or more and a maximum diameter at least 50% stenosis by visual estimation, PCI can be successfully implemented
- Sign an informed consent form before participating in the study
Exclusion Criteria:
- Received thrombolytic therapy
- Cardiac shock or SBP<90mmHg;
- History of old myocardial infarction;
- Left main artery lesion, non infarct related vessels are CTO lesions;
- PCI in the previous 30 days or Previous CABG
- Patients who cannot give informed consent or have a life expectancy of less than 1 year
- Patients combined with other serious diseases such as severe renal dysfunction (creatinine clearance value<30ml/min;), liver dysfunction and thrombocytopenia
- Patients with severe valve disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension;
- Not suitable for clinical research:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients presenting STEMI and multivessel coronary disease successful primary PCI of the culprit lesion (including those who still have ischemic symptoms within 48 hours)
- •Multivessel disease was defined at least one non-culprit coronary arteries with a diameter of 2.5 mm or more and a maximum diameter at least 50% stenosis by visual estimation, PCI can be successfully implemented
- •Sign an informed consent form before participating in the study
排除标准
- •Received thrombolytic therapy
- •Cardiac shock or SBP<90mmHg;
- •History of old myocardial infarction;
- •Left main artery lesion, non infarct related vessels are CTO lesions;
- •PCI in the previous 30 days or Previous CABG
- •Patients who cannot give informed consent or have a life expectancy of less than 1 year
- •Patients combined with other serious diseases such as severe renal dysfunction (creatinine clearance value<30ml/min;), liver dysfunction and thrombocytopenia
- •Patients with severe valve disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension;
- •Not suitable for clinical research:
- •Currently participating in another study that may affect the primary endpoint
- •Pregnant and lactating women;
- •Known allergy to drugs that may be used in the study;
- •Unable to comply with the trial protocol or follow-up requirements; Or the researcher believes that participating in the trial may result in patients facing greater risks.
结局指标
主要结局
MACCE
时间窗: At 1 year after the index procedure
The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischemia-driven revascularization, stroke or hospitalization for heart failure at 1 year after the index procedure.
次要结局
- All-cause mortality(At 1 months, 6 months, 1, 2 and 3 years after the index procedure)
- Cardiovascular death(At 1 months, 6 months, 1, 2 and 3 years after the index procedure)
- Myocardial Infarction(At 1 months, 6 months, 1, 2 and 3 years after the index procedure)
- TVR: Target vessel revascularization(At 1 months, 6 months, 1, 2 and 3 years after the index procedure)
- Stroke (Ischemic\hemorrhagic)(At 1 months, 6 months, 1, 2 and 3 years after the index procedure)
- Any coronary revascularization(At 1 months, 6 months, 1, 2 and 3 years after the index procedure)
- Contrast-induced acute kidney injury(At 1 months after the index procedure)
- MACCE(At 1 months, 6 months, 2 and 3 years after the index procedure)
- Stent Thrombosis(At 1 months, 6 months, 1, 2 and 3 years after the index procedure)
- Hospitalization for heart failure(At 1 months, 6 months, 1, 2 and 3 years after the index procedure)
- Major bleeding(At 1 months, 6 months, 1, 2 and 3 years after the index procedure)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
A Comparison Between FFR Guided and CAG Guided Treatment Using DEB in ISR of DESIn Stent RestenosisDrug Eluting StentCoronary Artery DiseaseNCT04518826Shanghai Zhongshan Hospital420
已完成
不适用
Diagnostic Accuracy of CFD-Based Fractional Flow Reserve Derived From Coronary AngiographyCoronary Artery DiseaseNCT04814550Second Affiliated Hospital, School of Medicine, Zhejiang University318
已完成
不适用
Prospective, Multicenter, Self-controlled Clinical Trial to Validate Optical Ultrasonic Flow Ratio (OUFR)Coronary Artery DiseaseNCT06726252Harbin Medical University114
终止
4 期
Fractional Flow Reserve (FFR) Versus Intravascular Ultrasound (IVUS) in Intermediate Coronary Artery DiseaseCoronary Artery StenosisNCT01175863Ajou University School of Medicine1,400
已完成
不适用
Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel DiseaseMulti Vessel Coronary Artery DiseaseNCT03455244CathWorks Ltd.50