Computed Tomography Coronary Angiography Prognostic Registry for Coronary Artery Disease - CTCA-PRORECAD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 11
- 主要终点
- MACE/Major Adverse Cardiovascular Events
研究概览
简要总结
The study aims at pooling a large population of patients with suspected coronary artery disease (CAD) who underwent Computed Tomography Coronary Angiography (CTCA) and who were adequately stratified in the first place. Then the investigators will be able to assess the incremental value of CTCA in the stratification of prevalence of disease (non obstructive/obstructive) and prognosis of patients with suspected CAD). The added information to current evidence is how reliable and to what extent CTCA can define the actual burden of disease and cardiovascular risk.
详细描述
The Project aims at pooling (retrospectively) a large population of patients with suspected coronary artery disease (CAD) who underwent Computed Tomography Coronary Angiography (CTCA) and who were adequately stratified in the first place. Then the investigators will be able to assess the incremental value of CTCA in the stratification of prevalence of disease (non obstructive/obstructive) and prognosis of patients with suspected CAD. The added information to current evidence is how reliable and to what extent CTCA can define the actual burden of disease and cardiovascular risk.
Primary objectives
- MACE/Major Adverse Cardiovascular Events (i.e. Cardiac Death, Unstable Angina requiring Hospitalization, Acute Myocardial Infarction)
- Prevalence of cardiovascular risk category shifting based on coronary plaque burden
Secondary objectives
- Coronary Revascularizations occurred after CTCA (i.e. PCI/Percutaneous Coronary Revascularization and CABG/Coronary Artery Bypass Graft)
- Prevalence of outliers (i.e. patients lying completely outside the conventional risk stratification; pts with >3 risk factors and no CAD at CTCA and pts with no risk factors and >5 coronary segments with CAD)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Only patients with also Calcium Score
- •≥64-slice CT technology (or 16-slice CT technology with >4 year follow-up)
- •Number of patients of at least 100 with complete clinical file and follow-up
- •Minimum follow-up of 12 months
- •Only patients with suspected Coronary Artery Disease
排除标准
- •renal failure (creatinine clearance <60ml/min)
- •known previous reaction to iodinated contrast medium and pregnancy
- •history of Myocardial Infarction
- •previous revascularization (PCI and/or CABG)
结局指标
主要结局
MACE/Major Adverse Cardiovascular Events
时间窗: at least 12 months
Cardiac Death, Unstable Angina requiring Hospitalization, Acute Myocardial Infarction
Cardiovascular risk shifting
时间窗: at time 0
Prevalence of cardiovascular risk category shifting based on coronary plaque burden
次要结局
- Coronary Revascularizations(after more than 90 days)
- Prevalence of outliers(at time 0)
研究者
Filippo Cademartiri
Associate Professor
Azienda Ospedaliero-Universitaria di Parma