SPARC, Including Its Pilot CT Angiographic Study, is a Prospective, Open-label, Multicenter, Sequentially Sampled, Observational Registry to Define the Clinical Value of Stress Perfusion (Stress SPECT, Stress PET), Noninvasive Angiography (CTA) and Combined Perfusion-anatomy (PET/CT) Studies in Patients With Known or Suspected CAD With Respect to Post-test Resource Utilization and Prediction of Cardiac Death and Non-fatal Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,019
- 试验地点
- 41
研究概览
简要总结
Three main clinical outcomes will be assessed:
- Post-test resource utilization as assessed by referral rate to catheterization within 90-days of the index study;
- Incremental prognostic value and risk stratification for predicting cardiac death and myocardial infarction;
- Cost-effectiveness
To this end, SPARC is organized with two distinct specific objectives with important differences in patient population and endpoints.
Specific Aim 1: To evaluate the impact of stress perfusion imaging with SPECT or PET, CT Angiography, and hybrid PET-CT on post-test resource utilization.
The primary endpoint of specific aim 1 is to compare the impact of combined myocardial perfusion-coronary anatomy data to that of perfusion only [stress SPECT, stress cardiac PET (without CTA)] and anatomy only (CTA alone) on post-test resource utilization, as measured by referral to cardiac catheterization within 90 days of index noninvasive testing, in patients without CAD.
Secondary endpoints:
- to compare the diagnostic accuracy for detection of epicardial CAD of stress PET and hybrid PET-CT, stress SPECT, and CTA, as defined by coronary angiography;
- to compare the referral rate to revascularization within 90 days of cardiac catheterization.
Specific Aim 2: To compare the incremental prognostic value and risk stratification of stress perfusion imaging with SPECT or PET, CT coronary angiography, and combined perfusion-anatomy imaging approaches.
The primary endpoint of specific aim 2 is to compare the incremental value of stress perfusion only (stress PET and stress SPECT), coronary anatomy only (CTA data), and combined perfusion-anatomy studies (PET+CTA and SPECT+CTA) over clinical, historical and stress test data for the prediction of cardiac death and nonfatal myocardial infarction.
Secondary endpoints:
- to compare the incremental value of these noninvasive imaging approaches over clinical, historical and stress test data for the prediction of a composite endpoint including cardiac death, nonfatal myocardial infarction, late (>6 month from index study) referral to revascularization, or late (>6 month from index study) hospitalization for chest pain or heart failure;
- to compare the incremental value of these noninvasive imaging approaches over clinical, historical and stress test data for the prediction of all cause mortality. In addition, the ability of these modalities -together and separately- to risk stratify patients is a primary goal of specific aim 2.
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
- •Referred for a clinical stress SPECT, stress PET, CTA or PET-CT study
- •Intermediate to high pretest likelihood for CAD (>.25;as defined by ACC/AHA Stable Angina Guidelines) without prior MI/PCI/CABG. These are considered diagnostic patients.
- •Documented known CAD as defined by prior MI/PCI/CABG
- •Provide signed informed consent to participate in the study
排除标准
- •Low pretest likelihood for CAD (<=.25; as defined by ACC/AHA Stable Angina Guidelines).
- •Major concomitant noncardiac disease or social condition/situation that in the opinion of the investigator will preclude the patient from participation in the study follow-up.
- •Concurrent or prior(within last 30 days) participation in other research studies using investigational drugs or devices.
- •Presence of a permanent automated internal cardiac defibrillator (AICD)
- •Known non-ischemic cardiomyopathy
- •Chest pain at rest within 48 hours prior to the index noninvasive imaging test
研究者
Marcelo F. Di Carli, MD, FACC
Chief, Division of Nuclear Medicine
Brigham and Women's Hospital
