Comprehensive Anatomical and Physiological Evaluation of Patients With Stable Coronary Artery Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- assess the accuracy of CCTA to quantify total atheroma volume (TAV) with IVUS as reference.
研究概览
简要总结
The COMPLETE study is a single-centre, investigator-initiated study of patients with an indication for invasive coronary angiography with CCTA performed during the diagnostic evaluation. After identifying the presence of a coronary stenosis, defined as an epicardial lesion >50% stenosis on CCTA, patients eligible for the study will be invited to participate.
The main aim of this trial is to assess the accuracy of coronary CT angiography to quantify total atheroma volume with intravascular ultrasound as reference.
Patients will be divided into 2 sub-groups:
Cohort 1: Patients with stable coronary artery disease or stabilized acute coronary syndromes with a clinical indication for invasive coronary angiography.
Cohort 2: Patients previously revascularized with a metallic stent with a clinical indication for invasive coronary angiography.
In both cohorts, patients should have undergone coronary CT angiography as part of the standard of care.
Patients included in the study will be managed according to the standard of care for the assessment of coronary artery disease. Clinical follow-up will be collected until 3 years follow-up.
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
- •1. Epicardial stenosis more than 50% by visual assessment.
排除标准
- •Hemodynamic instability.
- •Rapid atrial fibrillation, flutter or arrhythmia (HR > 80 bpm).
- •Insufficient CCTA image quality.
- •Age <18 years.
- •Chronic obstructive pulmonary disease.
- •Contraindication to adenosine.
- •NYHA class III or IV, or last known left ventricular ejection fraction <30%.
- •Uncontrolled or recurrent ventricular tachycardia.
- •History of recent stroke (≤90 days).
- •Prior myocardial infarction.
- •History of ischemic stroke (>90 days) with modified RANKIN score ≥
- •History of any hemorrhagic stroke.
- •Previous coronary artery bypass surgery.
- •Active liver disease or hepatic dysfunction, defined as AST or ALT > 3 times the ULN.
- •Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m
- •BMI >35 kg/m
- •Nitrate intolerance
- •Contra-indication to heart rate lowering drugs.
- •Unable to provide written informed consent.
结局指标
主要结局
assess the accuracy of CCTA to quantify total atheroma volume (TAV) with IVUS as reference.
时间窗: day 0 (day of the procedure)
To assess the accuracy of CCTA (Coronary Computed Tomography Angiography) to quantify total atheroma volume (TAV) with IVUS (Intravascular Ultrasound) as reference.
次要结局
- Assess the accuracy of CCTA to determine minimal stent area with IVUS as reference.(day 0 (day of the procedure))
- Determine the diagnostic performance (mean difference) of FFRCT in stented segments with invasive FFR as reference.(day 0 (day of the procedure))
- Describe the impact of coronary microvascular dysfunction assessed by IMR and absolute coronary resistance on the accuracy of FFRCT.(day 0 (day of the procedure)