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临床试验/NCT02178904
NCT02178904已完成不适用

Dual Energy Computed Tomography for Ischemia Determination Compared to "Gold Standard" Non-Invasive and Invasive Techniques

Weill Medical College of Cornell University5 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
156
试验地点
5
主要终点
Diagnostic accuracy of dual energy CCTA plus perfusion (DECTP) to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis* at the subject-level when compared to FFR.

研究概览

简要总结

The purpose of this study is determine the diagnostic performance of dual energy computed tomography perfusion for non-invasive assessment of the hemodynamic significance of coronary stenosis, as compared to a direct measurement of fraction flow reserve during cardiac catheterization as a reference standard.

The overall objective of the present study is to determine the diagnostic performance of dual energy computed tomography perfusion for non-invasive assessment of the hemodynamic significance of coronary stenosis, as compared to direct measurement of fraction flow reserve during cardiac catheterization as a reference standard.

详细描述

Coronary artery disease is the leading cause of morbidity and mortality in the United States. At present, professional guidelines endorse the use of an array of non-invasive tests for patients with suspected coronary artery disease, which are limited to one of two approaches: 1) physiologic demonstration of ischemia by functional stress testing or 2) anatomic visualization of stenosis by coronary computed tomographic angiography.

Stress test for physiologic assessment of coronary disease is performed most commonly with the prognostic value unsurpassed by other non-invasive tests, with risk of cardiac events escalating exponentially with increasing inducible hypoperfusion. However, despite its high reported performance, the "real world" accuracy of stress test is less sanguine and demonstrates generally poor discrimination of specific vessels that accommodate coronary lesions that cause ischemia. These findings have encouraged the adoption of other stress tests, such as positron emission tomography, which offers reliable attenuation correction, increased count sensitivity, lower radiation dose and enhanced diagnostic performance. Positron emission tomography also enables measures of absolute myocardial blood flow.

Coronary computed tomographic angiography is an alternative test that evaluates coronary disease by direct anatomic visualization of stenoses in a manner similar to cardiac catheterization. Similarly, when employing invasive fractional flow reserve to identify ischemia, high-grade stenoses observed by computed tomography are causal of ischemia less than half of the time.

Multicenter randomized trial data examining invasive methods have demonstrated that a combined anatomic-physiologic approach by catheterization with fractional flow reserve improves identification of patients who may benefit from revascularization, by restricting revascularization to those with high-grade stenoses that specifically cause ischemia. Nevertheless, the combination of catheterization with fractional flow reserve is invasive, is not widely adopted in clinical practice, and is costly.

Computed tomography perfusion is a novel non-invasive technique that can evaluate the physiologic significance of coronary disease, and is performed by adding a single image acquisition to computed tomography in the same setting. The combination of computed tomography perfusion to computed tomography may represent an ideal "one-stop shop" that may allow for both anatomic and physiologic evaluation of coronary disease, serve as a more effective gatekeeper to cardiac catheterization, and better identify patients that would benefit from revascularization.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Patients provide written informed consent
  • Patients scheduled to undergo clinically-indicated non-emergent invasive coronary angiography
  • suspected coronary artery disease

排除标准

  • Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)
  • Recent prior myocardial infarction within 40 days of ICA
  • Known complex congenital heart disease
  • Significant arrhythmia or tachycardia
  • Impaired chronic renal function (serum creatinine > 1.5 mg/dl or GFR < 30 ml/min)
  • Patients with known anaphylactic allergy to iodinated contrast
  • Pregnancy or unknown pregnancy status
  • Contraindication to adenosine, including 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome; severe hypotension, severe asthma, severe COPD or bronchodilator-dependent COPD
  • Patient requires an emergent procedure
  • Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema

结局指标

主要结局

Diagnostic accuracy of dual energy CCTA plus perfusion (DECTP) to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis* at the subject-level when compared to FFR.

时间窗: Within 60 days between CT and cath

Diagnostic accuracy of coronary computed tomography angiography plus dual energy computed tomographic perfusion to determine presence or absence of at least one hemodynamically-significant coronary artery stenosis at the subject level when compared to fractional flow reserve as the reference standard.

次要结局

  • Sensitivity, specificity, positive predictive value, and negative predictive value of coronary computed tomography angiography plus DECTP at the subject level using binary outcomes when compared to fractional flow reserve as the reference standard.(Within 60 days between tests)
  • Diagnostic performance (accuracy, sensitivity, specificity, PPV, and NPV) of CCTA plus DECTP for HD-significant stenosis* at the vessel-level when compared to FFR.(Within 60 days between tests)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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