Acute Chest Pain Treatment and Evaluation (ACTION) Study

NCT00434564 | Completed Phase 4

• 1 other identifier: NMRC/0517/2001
• Study Type: interventional
• Target: 1,690
• Locations: 1 country
• Sites: 1

Brief Summary

Objective

• 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.
• 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.

Conditions

Chest Pain

Keywords

Stress nuclear scan; Acute chest pain

Outcome Measures

Primary Outcomes (5)

• Cardiac related death

• Ventricular Fibrillation

• Myocardial Infarction

• Cardiogenic shock requiring intra-aortic balloon pump circulatory assistance

• Acute pulmonary oedema requiring endotracheal intubation

Secondary Outcomes (1)

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

Interventions

Stress nuclear scan PROCEDURE

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and above
• Chest pain suggestive of the angina
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead
• National Medical Research Council (NMRC), Singapore: collaborator
• National Heart Centre Singapore: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

Related Publications (13)

• 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. doi: 10.1016/0002-9149(87)90217-7.

  PMID: 3618483 BACKGROUND

• 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. doi: 10.1016/s0196-0644(05)81945-6.

  PMID: 8442548 BACKGROUND

• 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. doi: 10.1056/NEJM198405173102001.

  PMID: 6371525 BACKGROUND

• 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. doi: 10.1056/NEJM198411013111802.

  PMID: 6482932 BACKGROUND

• 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. doi: 10.1016/s0196-0644(95)70347-0.

  PMID: 7802357 BACKGROUND

• McGuinness JB, Begg TB, Semple T. First electrocardiogram in recent myocardial infarction. Br Med J. 1976 Aug 21;2(6033):449-51. doi: 10.1136/bmj.2.6033.449.

  PMID: 953603 BACKGROUND

• 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. doi: 10.1378/chest.71.4.486.

  PMID: 856546 BACKGROUND

• 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. doi: 10.1016/s0196-0644(87)80521-8.

  PMID: 3619163 BACKGROUND

• 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. doi: 10.1016/s0196-0644(05)82598-3.

  PMID: 2240745 BACKGROUND

• 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. doi: 10.1161/01.cir.83.3.902.

  PMID: 1999039 BACKGROUND

• 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. doi: 10.1161/01.cir.80.1.87.

  PMID: 2661056 BACKGROUND

• 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. doi: 10.1016/0002-8703(90)90159-u.

  PMID: 2360517 BACKGROUND

• 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. doi: 10.1161/01.cir.90.1.613.

  PMID: 8026048 BACKGROUND

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lim S Han, MBBS, FRCS

  Department of Emergency Medicine, Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2007
• First Posted: February 13, 2007
• Study Start: August 1, 2000
• Study Completion: May 1, 2002
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

SG (1)