Acute Chest Pain Treatment and Evaluation (ACTION) Study

This study has been completed.
Sponsor:
Collaborators:
National Medical Research Council (NMRC), Singapore
National Heart Centre of Singapore Pte Ltd
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT00434564
First received: February 12, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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 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.


Condition Intervention Phase
Chest Pain
Procedure: Stress nuclear scan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Chest Pain Treatment and Evaluation (ACTION) Study

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

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

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

Estimated Enrollment: 1690
Study Start Date: August 2000
Estimated Study Completion Date: May 2002
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00434564

Locations
Singapore
Singapore General Hospital
Singapore, Singapore
Sponsors and Collaborators
Singapore General Hospital
National Medical Research Council (NMRC), Singapore
National Heart Centre of Singapore Pte Ltd
Investigators
Principal Investigator: Lim S Han, MBBS, FRCS Department of Emergency Medicine, Singapore General Hospital
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00434564     History of Changes
Other Study ID Numbers: NMRC/0517/2001
Study First Received: February 12, 2007
Last Updated: February 12, 2007
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Singapore General Hospital:
Stress nuclear scan
Acute chest pain

Additional relevant MeSH terms:
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014