A Prospective Multi-center Study Comparing Cardiac Computed Tomography (CT) Using a 64-detector Row Volumetric Computed Tomography (VCT) Scanner for the Detection of Coronary Artery Disease With Cardiac Radionuclide Imaging.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 249
- 试验地点
- 2
- 主要终点
- Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth.
研究概览
简要总结
To determine the relative efficacy of Cardiac Computed Tomography Angiography (CCTA) and Single Positron Emission Computed Tomography (SPECT) in patients with an intermediate risk of CAD.
详细描述
This study is a prospective, multi-center, within-subject comparative study. One hundred fifty (150) subjects with CATH procedures are needed in the study. Approximately 300 subjects who meet all of the inclusion/exclusion criteria will be enrolled. The study population will consist of subjects with symptoms suspected of and at intermediate-risk for ischemic heart disease, which are referred for MPS for a definitive diagnosis of CAD.
Each subject will undergo the following procedures:
- A Myocardial Perfusion Study (MPS) procedure, as standard of care;
- An IV contrast-enhanced cardiac CT (CCTA) procedure;
- A CATH procedure when the MPS and/or cardiac CT examination is deemed positive or equivocal and at the discretion of the referring physicians, as a standard-of-care procedure.
When both the MPS and CCTA are normal, the subject is not required to undergo a CATH procedure, but will enter into follow-up. The research staff at each site will perform follow-up for each subject at 12 months (± 15 days) and 24 months (± 15 days) and 36 months (± 15 days) after the completion of the cardiac CT procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients with an intermediate probability risk for coronary artery disease.
- •Subject has symptoms of suspected ischemic heart disease.
- •Subject is at intermediate risk for coronary artery disease
排除标准
- •The subject has undergone a prior CCTA within 6 months prior to entering the study.
- •The subject has a documented history of CAD by CATH, myocardial infarction (MI), metal stent placement in any of the coronary vessels, or a previous coronary artery bypass graft (CABG) procedure
- •The subject has hemodynamic or active clinical instability:
- •Acute chest pain (sudden onset);
- •Cardiac shock;
- •Unstable blood pressure (BP);
- •Severe congestive heart failure or acute pulmonary edema.
结局指标
主要结局
Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth.
时间窗: through study completion, an expected average of 1 year
Number of subjects with CT for detection purposes
次要结局
- Clinical Outcomes - EKG, Laboratory Workup, Changes in Medical Management, Downstream Cardiac Testing, Significant Coronary Interventions, and Major Cardiac Events & Long-term Outcomes (Non-fatal MI and Cardiac-related Death).(1 year outcomes after initial MPS exam)