CT Perfusion Added to CT Angiography for Unstable Angina or Nonanginal Chest Pain in the Emergency Department (PERFeCT) : a Feasibility and Safety Pilot Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Event free survival
研究概览
简要总结
Background In the differential diagnosis of unstable angina versus non-anginal chest pain, an exercise test is often the modality of choice for further investigation. However, in a substantial number of patients exercise testing is less informative, because of insufficient exercise capacity or pre-existing ECG-abnormalities. In patients with low pretest probability of coronary artery disease (CAD), Coronary CT angiography (CTA) has an excellent negative predictive value, but in patients with an intermediate or high pretest probability of CAD estimation of the hemodynamic significance of a stenosis has only limited specificity. CT perfusion (CTP) is a new method looking at myocardial perfusion during vasodilative stress with a sensitivity, specificity, positive predictive value and negative predictive value of respectively 81%, 93%, 87% and 88%, whereas radiation is limited to a maximum of 5 millisievert (mSv).
Aim It is the aim of this pilot study to investigate whether the addition of CTP to CTA is a feasible and safe investigational workflow in patients with unstable angina or nonanginal chest pain in the emergency department.
详细描述
It is the aim of this pilot study to investigate whether the addition of CTP to CTA is a feasible and safe investigational workflow in patients with unstable angina or nonanginal chest pain in the emergency department.
Methods Patients presenting in the emergency department with thoracic pain or other symptoms suggestive of angina, will be eligible for the study if there are no ECG-signs of acute ischemia (no STEMI or NSTEMI) and if 2 serial high sensitivity Troponin T measurements with an interval of 1 hour are not conclusive for the diagnosis of ischemia.
Exclusion criteria are a history of a STEMI or a NSTEMI with residual functional abnormalities, atrial fibrillation, renal insufficiency with glomerular filtration rate (GFR) < 60 ml/min or known contrast allergy. A number of 100 patients in one year is targeted.
A pretest-probability score is calculated based on age, gender and type of angina of the patient. Typical angina is defined as substernal chest pain or discomfort provoked by exertion or emotional stress and relieved by rest or nitrates within minutes, atypical angina meets 2 of the 3 characteristics and nonanginal pain meets one or none of the characteristics. The time point of admission in the emergency department is recorded.(cf. Figure 1) Patients will undergo a CT (Siemens Somatom Force) with calcium-scoring and CT angiography (CTA). The amount of contrast used is about 60 ml, and the radiation varies between 0.5 and 1.5 mSv. If the CTA is completely normal and Ca-scoring is low (< 100), no further investigations are performed and the diagnosis of nonanginal pain is probable. Patients are dismissed from the emergency ward with follow-up organized for one year. Cf. Figure 2.
If there are abnormalities on CTA, or if there is a elevated Ca-scoring (> 300), even in the absence of stenosis on CTA, a CT perfusion sequence is added during dipyridamole stress. The amount of contrast used for CTP is about 50 ml and the radiation used for CTP varies between 3 to 4 mSv, resulting in a total radiation dose of less than 5 mSv. Dipyridamole is administered in a dose of 140 µg/kg body weight/minute during 6 minutes through a peripheral vein. CTP is performed 2 minutes after completion of the dipyridamole infusion.
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
- •Patient presents with chest pain in the ED
- •≥ 18 years of age
- •Patient is stable and in adequate clinical condition to undergo CTA + CTP
排除标准
- •no ECG-signs of acute ischemia (no STEMI or NSTEMI)
- •Hs Troponine T level/evolution indicative of ischemia
- •history of a STEMI or a NSTEMI with residual functional abnormalities
- •atrial fibrillation
- •renal insufficiency with glomerular filtration rate (GFR) =< 30 ml/min
- •Hb < 8.5 g/dL
- •Infection with systemic involvement
- •Baseline respiratory failure requiring oxygen at home
- •Severe COPD
- •Intrinsic astma
结局指标
主要结局
Event free survival
时间窗: two years
Registration of adverse cardiac events during clinical follow up
次要结局
- Impact of CTP on the diagnostic accuracy for the detection of obstructive CAD(two years)
- Quality of life(two years)
- Quality of life second(two years)
研究者
dr. Kaatje Goetschalckx
Dr in Cardiovascular Medicine
Universitaire Ziekenhuizen KU Leuven