Randomized Evaluation of Coronary Computed Tomographic Angiography in Intermediate-risk Patients Presenting to the Emergency Department With Chest Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,600
- 试验地点
- 2
- 主要终点
- The composite of death, readmission because of MI or unstable angina requiring revascularization
研究概览
简要总结
The aim is to determine whether a diagnostic strategy including early coronary computed tomographic angiography in intermediate-risk patients presenting to the Emergency Department with chest pain reduces the composite endpoint of death, readmission because of myocardial infarction or unstable angina requiring revascularization.
详细描述
Patients presenting to the ED with chest pain or other symptoms suggestive of ACS, without acute MI but with an intermediate risk (HEART-score >3) will after written informed consent be randomized to either a strategy with an initial CCTA or not.
Patients randomized to strategy including early CCTA will receive standard care according to responsible physician and perform a CCTA as soon as possible (in most cases within 24 hours, but at least within 21 days).The result will be presented to the responsible physician who will plan further care of the patients.
Patients randomized to a strategy not including early CCTA will receive further care (including examinations) according to responsible physician but not include early CCTA. These patients will often undergo a non-invasive functional test, such as Exercise-ECG, stress echocardiography or nuclear imaging according to local routines, but not always.
All patients should receive optimal prevention according to current guidelines. The responsible physician will be encouraged to initiate secondary prevention measures if examinations show signs of CAD.
The primary endpoint is composite of death, readmission because of MI or unstable angina requiring revascularization.
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)
盲法说明
Before adjudication, all documents will be masked regarding previous coronary computed tomographic angiography.
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
- •Age≥18 years.
- •Within 24 hours from presenting to the ED with chest pain or other symptoms suggestive of coronary artery disease (CAD)
- •HEART-score >3 (according to http://www.heartscore.nl/)
- •Written informed consent obtained
排除标准
- •Any condition that may influence the patient's ability to comply with study protocol.
- •Known obstructive CAD (>50%) or previous PCI or CABG.
- •Clear alternative diagnosis
- •Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
- •Major allergy to iodinated contrast media
- •Circumstances making high quality images unlikely.
- •Not a Swedish resident with a personal ID-number.
- •Pregnancy or breast feeding
- •Further investigation for CAD not indicated, due to limited life expectancy, quality of life or functional status
- •Previous inclusion in the trial
结局指标
主要结局
The composite of death, readmission because of MI or unstable angina requiring revascularization
时间窗: through study completion, an average of 5 year
death of any cause, readmission because of MI (I21) or revascularization because of unstable angina not related to the index event
次要结局
- Death or readmission because MI(through study completion, an average of 5 year)
- Death(through study completion, an average of 5 year)
- Resource use / Health care costs(through study completion, an average of 5 year)
- Non-obstructive CAD at first invasive coronary angiography(through study completion, an average of 5 year)
- Angina(1 year)
- Cardiovascular death(through study completion, an average of 5 year)
- Death, readmission because MI or stroke(through study completion, an average of 5 year)
- Invasive coronary angiography(through study completion, an average of 5 year)
- Use of prevention medications(1, 2 and 3 years)
- Stroke (fatal or non-fatal)(through study completion, an average of 5 year)
- Health-related quality of life(1 year)
- MI (fatal or non-fatal)(through study completion, an average of 5 year)
- Readmission because of unstable angina requiring revascularization(through study completion, an average of 5 year)
- Re-presentation to the ED because of chest pain(through study completion, an average of 5 year)
研究者
Dr. Tomas Jernberg
Principal Investigator, Clinical Professor
Karolinska Institutet