NCT03250455Unknown不适用
Prognostic Value of CT dynamIc Myocardial Perfusion in Patients With Obstructive Coronary Artery Stenosis
Chinese Academy of Medical Sciences, Fuwai Hospital5 个研究点 分布在 1 个国家目标入组 1,748 人开始时间: 2017年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,748
- 试验地点
- 5
- 主要终点
- MACE
研究概览
简要总结
VALIDITY is a prospective, open-label, multicenter, randomized controlled trial （ClinicalTrials.gov number）. The study was designed to evaluate the value of noninvasive anatomic CTA combined with functional CTP for the next clinical decision making and the added prognostic value of CTP beyond CTA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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.
- •stable chest pain with obstructive coronary stenosis (50-90%) assessed by CTA.
排除标准
- •(1) Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing; Elevated troponin or creatine kinase-myocardial band (CK-MB).
- •(2) Hemodynamically or clinically unstable condition systolic blood pressure (BP) < 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy.
- •(3) Known CAD with prior Myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG).
- •(4) Known significant congenital, valvular (> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (LVEF) ≤ 40%)) which could explain cardiac symptoms.
- •(5) Contraindication to undergoing CTA, including but not limited to: a. Allergy to iodinated contrast agent, b. Unable to receive beta blockers, c. creatinine ≥1.7 mg/dl or GFR≤30 ml/min , d. Pregnancy.
- •(6) Contraindication to ATP, including but not limited to: a. II or III atrioventricular block, b. bronchial asthma, c. hypotension (SBP<90mmHg), d. bronchial stenosis or bronchospasm, e. acute myocardial infarction, f. left main stenosis, g. unstable angina, h. allergy to aminophylline.
- •(7) Life expectancy < 2 years. (8) Unable to provide written informed consent or participate in long-term follow-up.
结局指标
主要结局
MACE
时间窗: 90 days, 6 months, 12 months, 24 months and 36 months
death, myocardial infarction and unstable angina requiring hospitalization
次要结局
- he incidence of a composite of major complications from cardiovascular procedures and testing(90 days, 6 months, 12 months, 24 months and 36 months)
- invasive coronary angiography and revascularization(90 days, 6 months, 12 months, 24 months and 36 months)
- Quality of Life(90 days, 6 months, 12 months, 24 months and 36)
- total medical cost(90 days and 3 years)
研究者
Bin Lu
chief of Radilogy
Chinese Academy of Medical Sciences, Fuwai Hospital
研究点 (5)
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