The Role of Early CT Coronary Angiography in the Evaluation, Intervention and Outcome of Patients Presenting to the Emergency Department With Suspected or Confirmed Acute Coronary Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,749
- 试验地点
- 39
- 主要终点
- All-cause Death or Subsequent Non-fatal Type 1 or Type 4b MI at One Year Measured as Time to First Such Event.
研究概览
简要总结
This study aims to investigate the effect of early CTCA in patients with suspected or confirmed Acute Coronary Syndrome (ACS) presenting to the Emergency Department (ED) or Medical Assessment Unit (MAU), upon interventions, event rates and health care costs in a pragmatic clinical trial and economic evaluation up to 1 year after the trial intervention. The primary objective will be to investigate the effect of the intervention on all-cause death or subsequent type 1 or type 4b MI at one year, measured as time to first such event.
详细描述
DESIGN: Open parallel group randomised controlled trial of early computed tomography coronary angiography (CTCA) in patients presenting with suspected/confirmed acute coronary syndrome (ACS) to Emergency Departments (ED) and Medical Assessment Units.
SETTING: 37 EDs, radiology, cardiology and acute medical services in tertiary/district general National Health Service (NHS) hospitals.
TARGET POPULATION: Inclusion Criteria: Patient ≥18 years with symptoms mandating investigation for suspected or confirmed ACS with at least one of: ECG abnormalities e.g. ST segment depression >0.5 mm; History of ischaemic heart disease (where the clinician assessing patient confirms history based on patient history or available records); Troponin elevation above the 99th centile of the normal reference range or increase in high sensitivity troponin meeting European Society of Cardiology criteria for 'rule-in' or myocardial infarction (NB troponin assays will vary from site to site; local laboratory reference standards will be used). Exclusion Criteria: 1.Signs, symptoms, or investigations supporting high-risk ACS: ST elevation MI; ACS with signs or symptoms of acute heart failure or circulatory shock; Crescendo episodes of typical anginal pain; Marked or dynamic ECG changes e.g. ST depression of >3 mm; Clinical team have scheduled early invasive coronary angiography on day of trial eligibility assessment. 2. Patient inability to undergo CT: Severe renal failure (serum creatinine >250 µmol/L or estimated glomerular filtration rate <30 mL/min); Contrast allergy; Beta blocker intolerance (if no alternative heart rate limiting agent available/suitable) or allergy; Inability to breath hold; Atrial fibrillation (where mean heart rate is anticipated to be greater than 75 beats per minute after beta blockade). 3. Patient has had invasive coronary angiography or CTCA within last 2 years and the previous investigation revealed obstructive coronary artery disease, or patient had either investigation within the last 5 years and the result was normal. 4.Previous recruitment to the trial; 5.Known pregnancy or currently breast feeding; 6. Inability to consent; 7.Further investigation for ACS would not in the patient's interest, due to limited life expectancy, quality of life or functional status; 8.Prisoners
HEALTH TECHNOLOGIES BEING ASSESSED: Early use of ≥64-slice CTCA as part of routine assessment compared to standard care.
MEASUREMENT OF COSTS/OUTCOMES: Primary end-point will be one-year all-cause death or subsequent type 1 or type 4b MI at one year, measured as time to first such event. Secondary endpoints: Key Secondary Endpoints : 1. Coronary Heart Disease (CHD) death or subsequent non-fatal MI; 2. Cardiovascular Disease (CVD) death or subsequent non-fatal MI; 3. Subsequent non-fatal MI; 4.Coronary Heart Disease death; 5. Cardiovascular death; 6. All-cause death. Other Endpoints; Coronary
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
All-cause Death or Subsequent Non-fatal Type 1 or Type 4b MI at One Year Measured as Time to First Such Event.
时间窗: 1 year (post randomisation)
Number of participants categorised as having primary outcome event - all-cause death or subsequent non-fatal myocardial infarction (type 1 or 4b) at one year (post randomisation), measured as time to first such event. Myocardial infarction 'type' was defined according to the most recent Universal Definition (1). and was adjudicated independently by two cardiologists blinded to the intervention and the categorisation added to the study database.
次要结局
- Radiation Exposure From CTCA as Trial Intervention(1 year (post randomisation))
- Coronary Revascularisation(1 year (post randomisation))
- Subsequent Non-fatal MI(1 year (post randomisation))
- Number of Patients Prescribed ACS Therapies During Index Hospitalisation(1 year (post randomisation))
- Representation or Rehospitalisation With Suspected ACS/ Recurrent Chest Pain After Index Hospitalisation(1 year (post randomisation))
- Coronary Heart Disease (CHD) Death or Subsequent Non-fatal MI (Type 1 or 4b)(1 year (post randomisation))
- Coronary Artery Bypass Graft(1 year (post randomisation))
- Length of Stay for Index Hospitalisation(A maximum follow up of one-year post-randomisation.)
- All-cause Death(1 year (post-randomisation))
- Subsequent Non-fatal MI (Type 1 or 4b)(1 year (post-randomisation))
- Invasive Coronary Angiography(1 year (post randomisation))
- Percutaneous Coronary Intervention(1 year (post randomisation))
- Discharged on Preventative Treatment or Alteration in Dosage of Preventative Treatment During Index Hospitalisation(1 year (post randomisation))
- Coronary Heart Disease Death or Subsequent Non-fatal MI(1 year (post randomisation))
- Cardiovascular Disease Death or Subsequent Non-fatal MI(1 year (post randomisation))
- Coronary Heart Disease Death(1 year (post randomisation))
- Cardiovascular Death(1 year (post-randomisation))
- Non-cardiovascular Death(1 year (post-randomisation))