Clinical Trial: Acute Chest Pain Treatment and Evaluation (ACTION) Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomised Trial on Early Stress Nuclear Scan for Patients Presented to the Emergency Department (ED) With Chest Pain But Non-diagnostic Electrocardiography-Acute

Brief Summary:

Objective

  1. 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
  2. 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 w

Detailed Summary:

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.

Stress nuclear imaging was also performed at the end of 6 hours of observation instead of graded exercise stress testing alone. There will be a significant proportion
Sponsor: Singapore General Hospital

Current Primary Outcome:

  • Cardiac related death
  • Ventricular Fibrillation
  • Myocardial Infarction
  • Cardiogenic shock requiring intra-aortic balloon pump circulatory assistance
  • Acute pulmonary oedema requiring endotracheal intubation


Original Primary Outcome: Same as current

Current Secondary Outcome: Requirement of emergency coronary revascularisation procedures like Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Graft (CABG)

Original Secondary Outcome: Same as current

Information By: Singapore General Hospital

Dates:
Date Received: February 12, 2007
Date Started: August 2000
Date Completion: May 2002
Last Updated: February 9, 2017
Last Verified: February 2017