Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,170
- 试验地点
- 9
- 主要终点
- Composite of myocardial infarction or cardiac death
研究概览
简要总结
Most patients presenting to hospital with symptoms of a heart attack are sent home without further tests once a heart attack has been ruled out. Current strategies to assess patients with a suspected heart attack involve blood tests to measure troponin, a protein released into the bloodstream when the heart muscle is damaged.
Despite having had a heart attack ruled-out, some patients have unrecognised heart disease and are at risk of having a heart attack in the future. However, clinicians do not know what is the best approach to identify and treat these patients.
This study will use a heart scan known as computed tomography coronary angiogram (CTCA) to look for unrecognised heart disease in patients who have had a heart attack ruled out. In an earlier study, the Investigators performed this scan in patients referred to the outpatient cardiology clinic with stable chest pain and found that this improved the diagnosis of heart disease, leading to improvement in patient care that prevented future heart attacks.
Previous research from the Investigators has also found that troponin levels below those used to diagnose a heart attack may help to identify those who are at greater risk of having a heart attack in the future.
The aim of this study is to find out if patients with these low levels of troponin, where a heart attack has been ruled out, will benefit from CTCA to look for unrecognised coronary heart disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
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
- •Presenting to hospital with symptoms of suspected acute coronary syndrome
- •Age 18 years and over
- •Maximum high-sensitivity cardiac troponin concentration between 5ng/L and the 99th percentile
排除标准
- •Diagnosis of myocardial infarction during index presentation
- •Clear alternative diagnosis or participant requires further inpatient clinical assessment
- •Recent CTCA or invasive coronary angiogram (within 1 year)
- •Patient inability to undergo CT scanning, e.g. due to severe renal failure (estimated glomerular filtration rate <30 mL/min) or major allergy to iodinated contrast media
- •Current pregnancy or breast feeding
- •Inability to give informed consent
- •Further investigation for coronary artery disease would not be in the patient's interest, e.g. due to limited life expectancy, quality of life or functional status
- •Previous randomisation into the trial
研究组 & 干预措施
CTCA with standard care
Patients will be referred for CT Coronary Angiography, ideally within 2 weeks of randomisation
干预措施: CT Coronary Angiography (CTCA) (Radiation)
Standard care
结局指标
主要结局
Composite of myocardial infarction or cardiac death
时间窗: Randomisation through to study completion, median duration of 36 months
The first event of myocardial infarction or cardiac death
次要结局
- Myocardial Infarction(Randomisation through to study completion, median duration of 36 months)
- Quality of life as assessed by the EQ-5D-5L(3, 12 and 24 months)
- Symptomatic status as assessed by the short form Seattle Angina Questionnaire (SAQ-7)(3, 12 and 24 months)
- Cardiac death(Randomisation through to study completion, median duration of 36 months)
- All-cause death(Randomisation through to study completion, median duration of 36 months)
- Unscheduled urgent coronary revascularisation(Randomisation through to study completion, median duration of 36 months)
- Cardiovascular death(Randomisation through to study completion, median duration of 36 months)
- Non-cardiovascular death(Randomisation through to study completion, median duration of 36 months)
- Hospital reattendance with suspected ACS(Randomisation through to study completion, median duration of 36 months)
- Proportion of patients with major bleeding (BARC 3-5)(Randomisation through to study completion, median duration of 36 months)