Acute Chest Pain Treatment and Evaluation (ACTION) Study - Full Text View

Sponsors and Collaborators:	Singapore General Hospital National Medical Research Council (NMRC), Singapore National Heart Centre, Singapore
Information provided by:	Singapore General Hospital
ClinicalTrials.gov Identifier:	NCT00434564

Purpose

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.

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

MedlinePlus related topics: Chest Pain Edema Heart Attack Nuclear Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

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

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, Singapore

Investigators

Principal Investigator:

Lim S Han, MBBS, FRCS

Department of Emergency Medicine, Singapore General Hospital

More Information

Publications:

Lee TH, Rouan GW, Weisberg MC, Brand DA, Acampora D, Stasiulewicz C, Walshon J, Terranova G, Gottlieb L, Goldstein-Wayne B, et al. Clinical characteristics and natural history of patients with acute myocardial infarction sent home from the emergency room. Am J Cardiol. 1987 Aug 1;60(4):219-24.

McCarthy BD, Beshansky JR, D'Agostino RB, Selker HP. Missed diagnoses of acute myocardial infarction in the emergency department: results from a multicenter study. Ann Emerg Med. 1993 Mar;22(3):579-82.

Pozen MW, D'Agostino RB, Selker HP, Sytkowski PA, Hood WB Jr. A predictive instrument to improve coronary-care-unit admission practices in acute ischemic heart disease. A prospective multicenter clinical trial. N Engl J Med. 1984 May 17;310(20):1273-8.

Kannel WB, Abbott RD. Incidence and prognosis of unrecognized myocardial infarction. An update on the Framingham study. N Engl J Med. 1984 Nov 1;311(18):1144-7.

Gibler WB, Runyon JP, Levy RC, Sayre MR, Kacich R, Hattemer CR, Hamilton C, Gerlach JW, Walsh RA. A rapid diagnostic and treatment center for patients with chest pain in the emergency department. Ann Emerg Med. 1995 Jan;25(1):1-8.

McGuinness JB, Begg TB, Semple T. First electrocardiogram in recent myocardial infarction. Br Med J. 1976 Aug 21;2(6033):449-51.

Behar S, Schor S, Kariv I, Barell V, Modan B. Evaluation of electrocardiogram in emergency room as a decision-making tool. Chest. 1977 Apr;71(4):486-91.

Gibler WB, Gibler CD, Weinshenker E, Abbottsmith C, Hedges JR, Barsan WG, Sperling M, Chen IW, Embry S, Kereiakes D. Myoglobin as an early indicator of acute myocardial infarction. Ann Emerg Med. 1987 Aug;16(8):851-6.

Gibler WB, Lewis LM, Erb RE, Makens PK, Kaplan BC, Vaughn RH, Biagini AV, Blanton JD, Campbell WB. Early detection of acute myocardial infarction in patients presenting with chest pain and nondiagnostic ECGs: serial CK-MB sampling in the emergency department. Ann Emerg Med. 1990 Dec;19(12):1359-66. Erratum in: Ann Emerg Med 1991 Apr;20(4):420.

Katus HA, Remppis A, Neumann FJ, Scheffold T, Diederich KW, Vinar G, Noe A, Matern G, Kuebler W. Diagnostic efficiency of troponin T measurements in acute myocardial infarction. Circulation. 1991 Mar;83(3):902-12.

Gianrossi R, Detrano R, Mulvihill D, Lehmann K, Dubach P, Colombo A, McArthur D, Froelicher V. Exercise-induced ST depression in the diagnosis of coronary artery disease. A meta-analysis. Circulation. 1989 Jul;80(1):87-98. Review.

Sawada SG, Ryan T, Conley MJ, Corya BC, Feigenbaum H, Armstrong WF. Prognostic value of a normal exercise echocardiogram. Am Heart J. 1990 Jul;120(1):49-55.

Braunwald E, Jones RH, Mark DB, Brown J, Brown L, Cheitlin MD, Concannon CA, Cowan M, Edwards C, Fuster V, et al. Diagnosing and managing unstable angina. Agency for Health Care Policy and Research. Circulation. 1994 Jul;90(1):613-22.

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

Keywords provided by Singapore General Hospital:

Stress nuclear scan
Acute chest pain

Study placed in the following topic categories:

Signs and Symptoms
Emergencies
Stress
Pain
Chest Pain

Additional relevant MeSH terms:

Signs and Symptoms
Pain
Chest Pain

ClinicalTrials.gov processed this record on May 07, 2009