Prospective RandOmised Trial of Emergency Cardiac CT
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- The primary objective will be to compare median hospital length of stay in each arm.
研究概览
简要总结
Patients who present to the emergency department (ED) with acute chest pain (ACP) possibly due to Coronary artery disease (CAD), with a normal heart tracing (ECG), need to have further troponin blood tests to confirm or exclude a heart attack. After initial troponin testing, a significant 50-85% of patients are said to be in an "observational zone" as one cannot confirm or exclude a diagnosis of a heart attack. Even after repeat blood testing, 22-33% remain in this "observational zone". These patients can be challenging to manage as they are not safe to be discharged home, but they also cannot be treated as a heart attack. This contributes to ED overcrowding and uncertainty in treatment plans.
详细描述
- Background Coronary artery disease (CAD) remains the most common cause of mortality in the world according to the World Health Organisation (WHO). Chest pain accounts for a significant healthcare burden representing approximately 700,000 annual visits to the emergency department in England and Wales [1]. Patients with acute chest pain (ACP) of possible cardiac origin account for approximately 17% of all emergency department (ED) consultations, but less than 10% of these are eventually diagnosed with acute myocardial infarction (AMI).
Hence a means of evaluating these patients in the ED in an efficient manner, whilst ensuring high sensitivity and specificity, is of paramount importance. Cardiac biomarkers e.g. cardiac Troponin (cTn) I or T along with electrocardiogram (ECG) remain the cornerstone in the evaluation of patients with suspected acute coronary syndrome (ACS).
1.1 Performance of high-sensitivity cardiac troponins High-sensitivity cardiac troponin (hs-cTn) assays enable the measurement of cTn at concentrations not detected with the former generation conventional cTn assays. In September 2015 hs-cTn assays were adopted in the European Society of Cardiology (ESC) guidelines for the management of patients with acute coronary syndrome (ACS) without persistent ST elevation. The proposed algorithms advocate either a single hs-cTn at ED presentation or repeat measurements after 1 or 2 hours thus enabling a more rapid "rule-in" and "rule out" of AMI compared with conventional cTn assays. The cut off values for the different hs-cTn assays are assay specific [2].
The performance of these algorithms (involving hs-cTn) has been evaluated in multiple studies. A prospective multicentre study by Gimenez et al looked at ruling out AMI using undetectable levels of hs-cTn (I and T) at presentation. With hs-cTnT, AMI was ruled out in 26.5% of cases with a negative predictive value (NPV) of 98.6%. Among three different hs-cTnI assays which were studied, the NPV ranged from 98.8% to 100%. No patient with undetectable levels of hs-cTnT died during the first 30 days and only 0.4% had died (2 patients not due to AMI) at 24 months' follow-up. Among the three hsc-TnI assays, mortality at 24 months ranged from 0 to 2.4% with only one death due to AMI (which occurred in the first 30 days) [3].
Although the more rapid risk-stratification with these algorithms (on the first sample of hs-cTn) helps in reduced time to rule-in or rule-out AMI there remains, however, (between the initial "rule-in" and "rule-out" categories) an intermediate "observational zone" category of patients, who do require a serial troponin test at 1 hour for further risk-stratification. Recent pilot data by Marjot et al have shown that, after initial hs-cTnT testing on presentation, there are a significant proportion of patients (54%) who would require further troponin testing after 1 hour as they were stratified in the observational zone on the initial troponin test. Despite the mandated repeated troponin at 1 hour, Marjot et al also showed that in real world practice, the mean time to repeat troponin was still 2.9 hours and that after training and implementation of the algorithm for 3 months, over 65% of patients still had their troponin taken at least 90 minutes after the first [4]. Similarly, in a sub-study of the ROMICAT II trial, Ferencik et al also found that a substantial 86.9% of patients had intermediate hs-cTn levels on initial testing and the addition of a second or third hs-cTn level did not improve risk stratification [5]. A study involving hs-cTnI (in a 2 hour algorithm) by Lindahl et al showed that, 47.1% remained in the observational zone on initial troponin. After a repeat troponin 2 hours later, 25.5% of patients, remained in the observational zone [6]. This presents an opportunity for a possible alternative means of further evaluating the initial observational zone cohort of patients in a more efficient manner.
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
- Double (Participant, Care Provider)
盲法说明
As stated earlier for patients assigned to Arm B i.e. the control arm (standard of care arm) who undergo CTCA, the results will not be released to the patient and their medical care givers in hospital.
CTCA interpretation followed by reporting will not take place in the acute hospital setting and therefore will be carried out within the following three weeks. Should the CTCA be found to have significant high risk CAD e.g. >50% stenosis in the left main (LM) coronary artery, and/or >50% stenosis in the proximal left anterior descending (LAD) coronary artery, they will be un-blinded and kept in a separate registry. Their results will be discussed with the hospital care team and if they have not had any invasive coronary imaging during the preceding hospital admission, an urgent cardiology out-patient referral will be made to enable further clinical management.
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
- •Patients above 18 years of age with ischaemic sounding chest pain prompting visit to the emergency department (suspected ACS).
- •No-ischaemic ECG changes (i.e. no ST-segment elevation or depression 1mm in 2 or more contiguous leads, and/or T-wave inversions).
- •Episode of chest pain within last 12 hours.
- •Initial troponin in the intermediate range (5-50ng/L).
排除标准
- •Signs and symptoms of acute heart failure and/or haemodynamic instability.
- •Dynamic ischaemic ECG changes.
- •Patient not suitable to undergo CTCA
- •Inability to breath hold for 10 seconds
- •Severe renal impairment (eGFR <30 mL/min)
- •Contraindication to beta-blockers (not relevant for patients with baseline sinus rhythm at rate of <63bpm)
- •Atrial Fibrillation on ECG.
- •Patients with known significant obstructive coronary artery disease (>50% stenosis) on previous invasive or CT coronary angiogram.
- •Patients with previous PCI/CABG revascularisation.
- •Patients with a history of congenital heart disease.
- •Patients with known coronary artery anomalies.
- •Patients who lack capacity to give consent or participate in the study.
- •Previous recruitment to the present study.
- •Known pregnancy or patients who are currently breast feeding.
- •Patients involved in current or a recent (within the last 4 months) CTIMP trial.
研究组 & 干预措施
Arm A (Cardiac CT)
Patients randomised to Arm A i.e. the intervention arm will under go standard of care patient hospital management but will also have cardiac CT angiogram (CTCA) carried out. Their subsequent clinical management will be left to clinician discretion in light of the additional CTCA results.
干预措施: Cardiac CT angiogram (Diagnostic Test)
Arm B (Standard of care arm)
Patients randomised to Arm B will receive usual standard of care management guided by serial troponin blood tests. These patients will also under go cardiac CT angiogram (CTCA) but these scans will not be used for the patients' in-hospital care.
Furthermore, unlike Arm A, CTCA interpretation followed by reporting will not take place in the acute hospital setting and therefore will be carried out within the following three weeks. Should the CTCA be found to have significant high risk CAD e.g. >50% stenosis in the left main (LM) coronary artery, and/or >50% stenosis in the proximal left anterior descending (LAD) coronary artery, they will be un-blinded and kept in a separate registry. Their results will be discussed with the hospital care team and if they have not had any invasive coronary imaging during the preceding hospital admission, an urgent cardiology out-patient referral will be made to enable further clinical management.
结局指标
主要结局
The primary objective will be to compare median hospital length of stay in each arm.
时间窗: Through 1 year
as above
次要结局
- Time taken to arrive at decision for admission or discharge(Through 1 year)
- Number of additional investigations during hospital stay (if admitted)(Through 1 year)
- Rates of out-patient clinic referrals at discharge(Through 1 year)
- Number of admissions in each arm; • Number of admissions in each arm; Number of hospital admissions in each arm(Through 1 year)
- Number of hospital discharges in each arm(Through 1 year)
- Proportion of patients with completeness of diagnosis on discharge(Through 1 year)
- Time taken for completeness of diagnosis in each arm(Through 1 year)
- Number of cardiac related hospital re-admissions in each arm over 1 year(Through 1 year)
- Rates of out-patient cardiac testing referrals at discharge(Through 1 year)
- Number of cardiac out-patient clinic visits during 1 year(Through 1 year)
- Number of cardiac related emergency department revisits in each arm over 1 year(Through 1 year)
- Patient Satisfaction/Quality of life at baseline, 1, 2, 3, 6, 9, and 12 months.(Through 1 year)