Functional and Anatomical Testing in Intermediate Risk Chest Pain Patients With Severe Coronary Calcium Score
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- Per-patient diagnostic accuracy of functional flow reserve (FFR-CT) derived from standard coronary computed tomography angiography (CCTA) compared to invasive coronary angiography (ICA) including functional flow ratio (FFR)
研究概览
简要总结
A prospective, blinded multicenter study for evaluation of chest pain patients with severe coronary calcium (Agatston score > 399). The objective is to evaluate if an initial non-invasive strategy with coronary computed tomography angiography (CCTA) including functional flow reserve derived from CCTA (FFR-CT) is as effective as invasive coronary angiography (ICA) including functional flow reserve (FFR) for the detection and exclusion of obstructive coronary artery disease (CAD). Study hypothesis: initial non-invasive anatomic and functional testing is non-inferior to an invasive anatomic and functional testing strategy.
详细描述
Prospective, blinded multicenter study evaluating the diagnostic performance of coronary computed tomography angiography (CCTA) including functional flow reserve derived from CCTA (FFR-CT) for the detection and exclusion of significant obstructive coronary artery disease (CAD). The reference standard vil be invasive coronary angiography (ICA) including functional flow reserve (FFR). Patients referred for elective CCTA because of suspected stable CAD are considered. If the initial routine non-enhanced CT scan shows an Agatston score > 399, the patient is eligible for study inclusion. Four sites in the region of Southern Denmark will participate (Odense University Hospital, Svendborg Hospital, Vejle Hospital and Esbjerg Hospital). A total of 278 patients will be included.
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
- •An estimated likelihood for the presence of significant CAD between 15% and 85%
- •Clinical stable patients with symptoms of suspected CAD referred for CTTA
- •Initial routine non-enhanced CT scan shows an Agatston score >399
- •Written informed consent
- •Accept to undergo elective invasive coronary angiography (ICA) within 90 days
排除标准
- •Known prior myocardial infarction
- •Prior percutaneous coronary intervention (PCI)
- •Prior coronary artery bypass surgery (CABG)
- •Pacemaker or internal defibrillator lead implantation
- •Prosthetic heart valve
- •Atrial fibrillation
- •Renal Insufficiency (<40 mL/min)
- •Known anaphylactic reaction to iodinated contrast
- •Pregnancy
结局指标
主要结局
Per-patient diagnostic accuracy of functional flow reserve (FFR-CT) derived from standard coronary computed tomography angiography (CCTA) compared to invasive coronary angiography (ICA) including functional flow ratio (FFR)
时间窗: Comparison of the noninvasive and invasive diagnostic modalities is performed at least 90 days after enrollment of each of the included patients
The primary outcome measure is the per-patient diagnostic accuracy of functional flow reserve (FFR-CT) derived from standard coronary computed tomography angiography (CCTA) compared to invasive coronary angiography (ICA) including functional flow ratio (FFR), which is considered the gold standard in the detection or exclusion of obstructive coronary artery disease (CAD)
次要结局
- Invasive coronary angiography (ICA) including functional flow ratio (FFR) without obstructive coronary artery disease(90 days after inclusion)
- Coronary revascularization procedures(90 day after inclusion)
- Per-vessel correlation of FFR-CT numerical value with the FFR numerical value in patients undergoing FFR(At least 90 days after patient inclusion)
- Other clinical endpoints(90 days after inclusion)
- Major complications from diagnostic invasive diagnostic procedures(Within 72 hours after invasive procedure)
- Per-patient and per-vessel diagnostic performance of FFR-CT by means of accuracy, sensitivity, specificity, positive predictive value, and negative predictive value(At least 90 days after patient inclusion)
- The diagnostic accuracy of FFR-CT in subgroups of patients with high calcium score vs. patients with very high calcium score(At least 90 days after patient inclusion)
- Costs and resource use.(90 days after inclusion)
研究者
Hans Mickley
Professor (chair), MD
Odense University Hospital