A Randomised Trial on Early Stress Nuclear Scan for Patients Presented to the Emergency Department (ED) With Chest Pain But Non-diagnostic Electrocardiography-Acute Chest Pain Treatment and Evaluation (ACTION) Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,690
- 试验地点
- 1
- 主要终点
- Cardiac related death
研究概览
简要总结
Objective
- To compare the incidence of adverse cardiac events among the patients discharged after evaluation through ACTION protocol with those through conventional protocol. The adverse cardiac events for the follow-up are defined as any of the followings:
- Cardiac related death
- Ventricular fibrillation
- Myocardial infarction
- Cardiogenic shock requiring the inta-aortic balloon pump circulatory assistance
- Acute pulmonary oedema requiring endo-tracheal intubation
- To study the sensitivity / predictive values of the various components of ACTION :12 lead ECG ST monitoring , serial serum markers for myocardial necrosis (myoglobin, CKMB, TnT, graded exercise testing, stress tetrofosmin scan/ stress echocardiography) in predicting adverse cardiac events.
Design -prospective randomised clinical trial
Participants
-patients above 25 years of age presenting to the ED with chest pain consistent with myocardial ischaemia but with a 12 lead ECG non-diagnostic of myocardial ischaemia .
Intervention
Patients were monitored continuously with a 12 lead ECG and ST segment trend monitoring and blood will be drawn at 0,3,6 hours after arrival at ED for serial myoglobin, creatine kinase MB isoenzyme (CKMB) and Troponin T (TnT) . Patients who have ECG and blood test consistent with myocardial necrosis were admitted to the CCU. A senior doctor in the ED reviewed patients who were not admitted after 6 hours of observation.
Study Group
A stress tetrofosmin nuclear scan was done . Patients were then admitted and discharged depending on the results of the stress tetrofosmin scan.
Control group (conventional protocol)
Patients were then be admitted or discharged at the discretion of the senior ED doctor.
Measurement Patients were followed up at 1 week , 2 weeks , one month and six months for any adverse cardiac events such as cardiac related death , ventricular fibrillation , and myocardial infarction.
Statistical analysis Logistic regression analysis were used to compare the proportion of adverse events in the two treatment groups.
详细描述
Identifying the cause of chest pain is a challenge to the Emergency Physician.Coronary artery disease is the most common group of Emergencies that has a high potential for rapidly developing a lethal outcome.
Significant proportion of patients who presented to and released from the Emergency Department (ED)with AMI or unstable angina develop poor outcomes. This is because a large proportion of AMI present atypically.The initial single 12 lead ECG done at an ED is only 50% sensitive for AMI.Serial ECGs have been shown to improve sensitivity by 25%.Because of these limitations, physicians may admit patients with chest pain, liberally. On the other hand only 25-50 % of patients admitted to CCU without AMI are eventually determined to have Acute Coronary Syndrome.
Several serum cardiac markers such as myoglobulin, CKMB and Troponin T (TnT) are found to increase sensitivity in detecting AMI than just history and ECG. Among them TnT is a better predictor of adverse cardiac event than CKMB. Absence of TnT elevation identifies a lower risk group of patients , but not necessarily a low risk group since TnT cannot detect myocardial ischaemia in the absence of myocardial injury or myocyte cell death.
There has been some chest pain evaluation practice in the ED using the graded exercise testing to screen for severe ischaemia.
Several studies have suggested the safety of exercise testing in low risk patients presenting to ED with chest pain.The use of exercise testing has been found to be a powerful tool for prognostication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •25 years and above
- •Chest pain suggestive of the angina
- •12 leads ECG non-diagnostic for myocardial ischaemia or AMI
- •diabetes mellitus
- •family history of young AMI (less than 50 years old) There is no lower limit of age for those patients in the last two categories
排除标准
- •ECG diagnostic of AMI or acute myocardial ischaemia (as defined by the new Q wave , ST elevation or depression greater than 1mm or 0.1 millivolts in two or more contiguous leads)
- •Congestive heart failure or hypotensive patients
- •Persistent chest pain consistent with unstable angina
结局指标
主要结局
Cardiac related death
Ventricular Fibrillation
Cardiogenic shock requiring intra-aortic balloon pump circulatory assistance
Acute pulmonary oedema requiring endotracheal intubation
Myocardial Infarction
次要结局
- Requirement of emergency coronary revascularisation procedures like Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Graft (CABG)