Intravascular Ultrasound-derived Morphometric Assessment of Fractional Flow Reserve Negative Lesions to Predict Cardiovascular Outcomes in Non-ST-segment Acute Coronary Syndrome Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- The incidence and predictors of MACEs related to FNLs
研究概览
简要总结
This is an observational and prospective cohort study to examine whether the addition of IVUS plaque morphological evaluation to FFR haemodynamic assessment of non-culprit lesions in NSTEACS patients will better predict MACEs.
详细描述
IMPACT-NSTEACS is a prospective, single-centre and dynamic observational study. The study population consists of NSTEACS patients who undergo FFR in lesions with intermediate to severe angiographic stenosis. Then, FFR-guided PCI is performed, followed by morphological assessment based on IVUS in all FFR-negative lesions (FNLs). After discharge all patients receive optimal medication treatment and are followed up clinically. On the basis of follow-up angiography, MACEs are further adjudicated as occurring at FNLs or not.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to high risk NSTEACS requiring invasive strategy based on current guidelines and local clinical practice.
- •Patient agrees and is able to follow all protocol procedures.
排除标准
- •STEMI or SCAD.
- •Hemodynamic instability (e.g. cardiogenic shock, refractory ventricular arrhythmias, acute and severe conduction system disease and left ventricular ejection fraction ≤30%).
- •Contraindication for FFR, PCI, IVUS and OMT (e.g. severe allergy to antiplatelet drug or contrast, significant bleed within the past 6 months, bleeding diathesis and serum creatinine ≥2.5 mg/dl).
- •PCI within 6 months or any prior CABG.
- •Anticipated life expectancy <3 year.
- •Unwilling or unable to provide informed consent
- •Imaging Inclusion Criteria
- •Patients must have at least > 1 de novo lesion in a native coronary segment with a visually estimated diameter stenosis of between 40 and 90 %.
- •Successful FFR-guided PCI performed in all major epicardial coronary arteries (including their branches): PCI for all lesions a) with 40%-90% diameter stenosis and FFR<0.8 and b) with ≥90% diameter stenosis.
- •The FFR-negative lesions must be available for assessment of IVUS.
- •Imaging Exclusion Criteria:
- •Target lesion reference diameter <2.0 mm.
- •Anatomic conditions precluding FFR and IVUS (e.g. marked calcification or tortuosity, chronic total occlusion or thrombus).
- •After successful FFR-guided PCI, no FNL is left.
- •Any remaining lesion with diameter stenosis ≥90% or FFR<0.8 after PCI.
- •Left main coronary artery lesion.
- •CABG planned by the investigators according to extent and severity of coronary artery disease.
结局指标
主要结局
The incidence and predictors of MACEs related to FNLs
时间窗: 3 years
Composite of death from cardiac causes, myocardial infarction, rehospitalization due to unstable or progressive angina and clinically-driven target lesion revascularization
次要结局
- The incidence of MACEs related to PCI-treated lesions(3 years)
研究者
Ying Zhang
Senior Physician
Tianjin Chest Hospital