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临床试验/NCT01521468
NCT01521468已完成不适用

Prospective Comparison of Cardiac PET/CT, SPECT/CT Perfusion Imaging and CT Coronary Angiography With Invasive Coronary Angiography

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
210
试验地点
1
主要终点
Improving prognostication

研究概览

简要总结

A large number of cardiac catheterizations are performed each year, primarily to diagnose heart disease. However, a cardiac catheterization is an invasive procedure which is associated with serious complications such as heart infarction, stroke, and death. Therefore, there is a need for non-invasive procedures to diagnose coronary heart disease. The purpose of this study is, therefore, to assess the diagnostic accuracy of non-invasive cardiac imaging modalities for the detection of heart disease in patients presenting for the first time to the cardiologist with chest pain.

详细描述

Coronary artery disease (CAD) remains the leading cause of morbidity and mortality in Western civilized countries. Early detection of CAD allows optimal therapeutic management in order to decrease morbidity and mortality. In the Netherlands 80,000 invasive coronary angiographies are performed each year. Invasive coronary angiography (ICA), particularly in conjunction with fractional flow reserve (FFR) measurements, is considered the gold standard in diagnosing and evaluating the severity of CAD in the current era. FFR measurements during ICA are useful in determining whether a coronary stenosis is functionally important. An FFR < 0.80 is considered abnormal, reflecting a hemodynamic significant coronary stenosis. ICA has superior spatial and temporal resolution compared with non-invasive imaging techniques. However, ICA is an invasive procedure which is associated with a low, though significant, complication rate including bleeding, coronary artery dissections, cerebral embolism, cardiac arrhythmias, myocardial infarction and death. Moreover, ICA provides only limited information on the presence of atherosclerotic plaques not associated with luminal stenosis. Furthermore, conventional catheter angiography without the advent of FFR measurements, is not able to provide information about the hemodynamic significance of a significant luminal stenosis (≥ 70%), i.e. whether a coronary artery stenosis is leading to myocardial perfusion abnormalities. Therefore, there is a need for non-invasive imaging techniques for diagnosing and evaluating the hemodynamic significance of CAD. Non-invasive techniques can serve as a gatekeeper for invasive coronary angiographies in order to decrease the number of purely diagnostic invasive angiographies and associated morbidity and mortality. The detection and management of cardiovascular disease increasingly utilize non-invasive cardiac imaging in patients with suspected or known CAD. By more accurately identifying patients who are eligible for coronary revascularization with the use of non-invasive cardiac imaging, the number of unnecessary invasive diagnostic coronary angiographies can be decreased.

Study design

Positron emission tomography:

PET images will be acquired using a Gemini Time-of-Flight (TF) 64 scanner (Philips Healthcare, Best, The Netherlands). Quantitative myocardial perfusion at rest and during hyperemia in ml -1. min -1. g -1 of myocardial tissue will be measured using oxygen-15-labelled water (H215O). Pharmacological stress is induced by infusion of adenosine intravenously at a rate of 140 µg/kg/min. Two minutes after the start of adenosine vasodilation reaches a steady state and H215O will be given intravenously as a bolus followed with the start of a 6-minutes emission scan. Directly after the PET sequence, a low dose CT attenuation scan (CTAC) is acquired after which the infusion of adenosine is terminated. Technetium-99m sestamibi is injected intravenously after the second CTAC scan. A stress SPECT-scan is performed 45 minutes after the stress PET scan.

Single photon emission computed tomography:

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First presentation to cardiologist with suspected coronary artery disease
  • No documented prior history of coronary artery disease
  • Intermediate pre-test likelihood for coronary artery disease as defined by Diamond and Forrester criteria
  • Clinically referred for invasive coronary angiography
  • Age above 40 years

排除标准

  • History of severe chronic obstructive pulmonary disease (COPD) or chronic asthma
  • Pregnancy
  • Renal failure ( i.e. estimated glomerular filtration rate < 45 mL/min)
  • Use of sildenafil (Viagra) or dipyridamole (Persantin) that can not be terminated.
  • Contra-indications for β-blockers
  • Allergic reaction to iodized contrast
  • Concurrent or prior (within last 30 days) participation in other research studies using investigational drugs
  • Claustrophobia
  • Significant co-morbidities
  • Atrial fibrillation, second or third degree atrioventricular block
  • Tachycardia
  • Acute myocardial infarction
  • Heart failure
  • Left ventricle ejection fraction estimated < 50%
  • Cardiomyopathies
  • Previous radiation exposure in the diagnostic work-up
  • Subjects intended for short-term medical treatment or an invasive coronary intervention
  • No informed consent

结局指标

主要结局

Improving prognostication

时间窗: Ten years

To compare the ability and incremental value of non-invasive stand-alone and cardiac hybrid imaging over clinical, historical and exercise test data for the prediction of all cause mortality.

Diagnostic accuracy of CTCA, SPECT and PET

时间窗: Invasive coronary angiography + fractional flow reserve measurements within 1 week of the initial scans

Determining the diagnostic accuracy of stand-alone cardiac imaging modalities

Non-invasive imaging for risk stratification

时间窗: Ten years

To determine the prognostic value of CTCA, SPECT, quantitative PET, hybrid SPECT/CTCA and PET/CTCA for predicting cardiac death and nonfatal myocardial infarction.

Head to head comparison between hybrid SPECT/CTCA and PET/CTCA

时间窗: Invasive coronary angiography + fractional flow reserve measurements within 1 week of the initial scans

A head-to-head comparison will be performed to assess the diagnostic accuracy of stress hybrid PET/CTCA and hybrid SPECT/CTCA for the detection of obstructive coronary artery disease as defined by invasive coronary angiography in combination with fractional flow reserve measurements.

次要结局

  • Risk stratification(> 6 months)

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Knaapen

MD, PhD

Amsterdam UMC, location VUmc

研究点 (1)

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