Myocardial Perfusion 320 MDCT Guided Treatment Strategy for the Clinical Management of Patient With Recent Acute-onset Chest Pain. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 8
- 主要终点
- Frequency of coronary revascularization among included patients referred for invasive investigation
研究概览
简要总结
The aim of this study is to assess whether the clinical management of patients with recent acute-onset chest pain without acute coronary syndrome may be optimized by a combined coronary CT angiography (CTA) + CT myocardial perfusion (CTP) guided, rapid diagnostic strategy as compared to CTA alone. CT diagnostic evaluation and potential referral for invasive testing will be performed within 2 weeks after hospital discharge.
The following main hypothesis will be tested:
- Combined assessment of coronary anatomy and myocardial perfusion using 320 MDCT results in a safe and optimized, cost-effective invasive treatment strategy
详细描述
MATERIAL
- Consecutive patients referred with chest pain in whom acute coronary syndrome has been excluded, yet with a maintained clinical suspicion of coronary artery disease will be included in the study. Only patients deemed clinically suited for subsequent invasive evaluation and treatment will be included.
METHODS
-If the patients accept participation in the trial a computerized 1:1 randomization for CTA alone (control group) or CTA and CTP combined (intervention group) within 2 weeks from discharge will be conducted. CT angiography and CT myocardial perfusion imaging will be performed using a 320-slice MSCT Toshiba VISION Edition Aquilion One scanner according to recommendations from the vendor and clinical routine developed at Rigshospitalet. Based on CTA and/or CTP findings patients will be referred for invasive evaluation including fractional flow reserve assessment (FFR) and treatment within 30 days. Invasive procedures will be performed according to international guidelines and the frequency of revascularization procedures recorded. Clinical outcome data according to specified secondary endpoints will be recorded from hospital charts and medical registries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent acute-onset chest pain where coronary artery disease is suspected
- •During initial acute hospitalization:
- •Normal coronary biomarkers (Troponins)
- •No or non-diagnostic ECG changes (LV hypertrophy, bundle branch blok, pacemaker rhythm)
- •Age ≥50 years
- •≥ 1 cardiovascular risk factor (family history of CAD, hypertension, hypercholesterolemia, diabetes, smoking) corresponding to a Duke clinical score ≥20%
排除标准
- •Known Iodine contrast allergy
- •Estimated GFR below 50 ml/min
- •Adenosine intolerance - known allergic asthma
- •Previous CABG
- •Patient related circumstances which preclude informed consent from the patient
- •Patients in whom psychiatric, physical or geographic conditions do not allow long-term clinical followup
- •Expected survival of less that 2 years
结局指标
主要结局
Frequency of coronary revascularization among included patients referred for invasive investigation
时间窗: Within 60 days of study inclusion
Among patients referred for invasive coronary evaluation the frequency of subsequent PCI and/or CABG is recorded
次要结局
- Hospital admittance due to recurrence of chest pain, acute myocardial infarction or cardiac death(Within 3, 12 and 24 months after CT examination)
- New referral for invasive investigation following inititial evaluation(3, 12 and 24 months after CT examination)
- Coronary revascularization - not including revascularization related to index evaluation(3, 12 and 24 months after CT examination)
- Invasive procedure related events(Within 30 days of invasive procedure)
研究者
Klaus Fuglsang Kofoed
Associate Professor
Rigshospitalet, Denmark