Screening for Coronary Artery Disease USing Primary Evaluation With Coronary Computed Tomography Angiography (CCTA) in Aviation Medicine (SUSPECT)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- UMC Utrecht
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Determine the prevalence and severity of CAD in asymptomatic air crew using CCTA as a primary screening tool
研究概览
简要总结
SUSPECT is a prospective, single-center, cohort study of 250 military aircrew at the Center for Man in Aviation, Royal Netherlands Air Force. All asymptomatic aircrew (≥40 years) are asked to undergo a coronary CT scan on a voluntary basis, following the exercise electrocardiograms performed at their routine aeromedical examination. Coronary Artery Calcium score (CACS) and CCTA findings are reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Military aircrew of the Royal Netherlands Air Force
- •≥ 40 years old
- •Required to undergo cardiac screening (per military aviation regulations)
排除标准
- •Typical angina
- •Prior myocardial infarction
- •Prior revascularization therapy (i.e. percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG))
- •Left ventricular ejection fraction <35%
- •Does not comprehend study requirements, and/or is unwilling or unable to comply to study procedures
- •CT-related contra-indications
- •Allergic to iodine contrast.
- •Renal insufficiency (GFR <60 ml/min/1.73m2, calculated with the Modification of Diet in Renal Disease (MDRD) calculator: http://nephron.org/mdrd_gfr_si.
- •Severe claustrophobia.
- •Uncontrolled irregular heart rhythm or tachycardia unresponsive to beta blockade
- •Pregnancy
研究组 & 干预措施
CT Angiography
Coronary CT Angiography will be performed on all individuals
干预措施: CT Angiography (Radiation)
Exercise stress test
An bicycle exercise stress test will be performed on all individuals
干预措施: Exercise stress test (Diagnostic Test)
结局指标
主要结局
Determine the prevalence and severity of CAD in asymptomatic air crew using CCTA as a primary screening tool
时间窗: 8 Years
次要结局
- Determine the diagnostic accuracy of clinically relevant CAD of the exercise stress test versus CCTA(8 Years)
- Compare the incidence of Major Adverse Cardiac Events (MACE) and all-cause mortality in populations screened between primary and secondary screening after 12 months(8 Years)
- Establish the additive value of coronary artery calcium score (CACS) in addition to clinical risk scores as a predictor of CAD on CCTA(8 Years)
- Compare the incidence of coronary angiograms and revascularization procedures in the population screened with CTA compared to a historical population using CTA as a secondary screening tool(8 Years)
研究者
Erik Frijters
Principal Investigator
UMC Utrecht