Study Results
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View full resultsBasic Information
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COMPLETED
602 participants
OBSERVATIONAL
2013-03-31
2014-10-31
Brief Summary
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Detailed Description
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An ever increasing evidence base is emerging from emergency departments in different geographical settings, using different combinations of clinical assessment tools, more rapid biochemical tests and variable outcomes. While making an accurate diagnosis is clearly important, from the patients' perspective it is more important to minimize the risk of adverse events. Therefore, the identification of tools which allow risk stratification to permit very low risks of MACE is more clinically relevant to ED specialists than the precise diagnostic label applied to the patient.
In the Asia-Pacific region a 2-hour diagnostic protocol involving serial point-of-care biomarkers, such as troponin I, creatine kinase MB, and myoglobin, combined with electrocardiograph (ECG) changes and a Thrombolysis in Myocardial Infarction (TIMI) score has been shown to safely exclude 30-day MACE in low risk patients with chest pain. Highly sensitive troponin T (hs-cTnT) and troponin I (hs-cTnI) perform well in the early diagnosis of acute myocardial infarction (AMI), non-ST elevation myocardial infarction (NSTEMI) and in the prediction of two year mortality. Undetectable levels of hs-cTnT alone at initial blood testing appears to rule-out 60-day NSTEMI with a negative predictive value of 94% and a sensitivity of 90%. A TIMI score incorporating hs-cTnT was no better at predicting 30-day MACE than front-door TIMI alone without measurement of biomarkers, but the value of a TIMI score of zero in ruling-out low risk patients was not demonstrated.
Despite evidence favouring early rule out pathways, there is still a need for further validation and refinement of such tools using different diagnostic pathways, in other clinical settings, and with other clinical tools such as HEART.
In this study we aimed firstly to evaluate the effectiveness of a combined use of an early modified TIMI score with hs-cTnT and a modified HEART score to rule out MACE in 30 days. Applying this protocol in clinical practice has the potential to reduce ED waiting times, ED crowding and hospital admission rates for chest pain patients.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Not low risk for MACE in 30 days
Patients with not low risk of major adverse cardiac events within 30 days Patients with TIMI\>0 or mHEART\>2
Routine blood test for hs-cTnT and Thrombolysis in myocardial infarction (TIMI) score were performed on study patients
Protocol amendment:
In October 2014, mHEART score of the study patients was determined retrospectively
Thrombolysis in myocardial infarction score
An English- and Cantonese-speaking research nurse obtained the TIMI scores which consists of seven variables from each eligible patient.
routine blood test for hs-cTnT
Patient had routine venipuncture blood taking for hs-cTnT measurement in the central laboratory of the hospital. Normal level of hs-cTnT is below 14ng/L.
HEART score
The modified HEART score of each patient was determined retrospectively by a research assistant.
Low risk for MACE in 30 days
Patients with low risk of major adverse cardiac events within 30 days
Patients with TIMI=0 and mHEART\<=2
Routine blood test for hs-cTnT and Thrombolysis in myocardial infarction (TIMI) score were performed on study patients
Protocol amendment:
In October 2014, mHEART score of the study patients was determined retrospectively
Thrombolysis in myocardial infarction score
An English- and Cantonese-speaking research nurse obtained the TIMI scores which consists of seven variables from each eligible patient.
routine blood test for hs-cTnT
Patient had routine venipuncture blood taking for hs-cTnT measurement in the central laboratory of the hospital. Normal level of hs-cTnT is below 14ng/L.
HEART score
The modified HEART score of each patient was determined retrospectively by a research assistant.
Interventions
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Thrombolysis in myocardial infarction score
An English- and Cantonese-speaking research nurse obtained the TIMI scores which consists of seven variables from each eligible patient.
routine blood test for hs-cTnT
Patient had routine venipuncture blood taking for hs-cTnT measurement in the central laboratory of the hospital. Normal level of hs-cTnT is below 14ng/L.
HEART score
The modified HEART score of each patient was determined retrospectively by a research assistant.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chest pain within 24 hours of ED presentation
* Suspected with ACS
Exclusion Criteria
* Hemodynamic or clinical instability (SBP\<90 mmHg, clinically significant atrial/ventricular arrhythmias)
* Initial ECG suggestive of ACS, Acute Myocardial Infarction or other abnormality requiring admission to hospital
* Previous coronary artery bypass grafting or coronary stent implantation
* Women with known or suspected pregnancy
* Unable or unwilling to provide informed consent
* Unable to be contacted after discharge
* Contraindication to β-blockade if prescription of β-blockade is required due to a resting heart rate over 80 beats per minute
18 Years
ALL
No
Sponsors
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Prince of Wales Hospital, Shatin, Hong Kong
OTHER
Food and Health Bureau, Hong Kong
OTHER_GOV
Chinese University of Hong Kong
OTHER
Responsible Party
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Timothy H Rainer
Director & Professor
Principal Investigators
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Timothy H Rainer, MD FCEM
Role: PRINCIPAL_INVESTIGATOR
Accident & Emergency Medicine Academic Unit
Locations
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Prince of Wales Hospital
Hong Kong, , China
Countries
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References
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Pope JH, Aufderheide TP, Ruthazer R, Woolard RH, Feldman JA, Beshansky JR, Griffith JL, Selker HP. Missed diagnoses of acute cardiac ischemia in the emergency department. N Engl J Med. 2000 Apr 20;342(16):1163-70. doi: 10.1056/NEJM200004203421603.
Chou KL, Chow NW, Chi I. Preventing economic hardship among Chinese elderly in Hong Kong. J Aging Soc Policy. 2004;16(4):79-97. doi: 10.1300/J031v16n04_05.
Bernstein SL, Aronsky D, Duseja R, Epstein S, Handel D, Hwang U, McCarthy M, John McConnell K, Pines JM, Rathlev N, Schafermeyer R, Zwemer F, Schull M, Asplin BR; Society for Academic Emergency Medicine, Emergency Department Crowding Task Force. The effect of emergency department crowding on clinically oriented outcomes. Acad Emerg Med. 2009 Jan;16(1):1-10. doi: 10.1111/j.1553-2712.2008.00295.x. Epub 2008 Nov 8.
Viswanathan K, Kilcullen N, Morrell C, Thistlethwaite SJ, Sivananthan MU, Hassan TB, Barth JH, Hall AS. Heart-type fatty acid-binding protein predicts long-term mortality and re-infarction in consecutive patients with suspected acute coronary syndrome who are troponin-negative. J Am Coll Cardiol. 2010 Jun 8;55(23):2590-8. doi: 10.1016/j.jacc.2009.12.062.
Kilcullen N, Viswanathan K, Das R, Morrell C, Farrin A, Barth JH, Hall AS; EMMACE-2 Investigators. Heart-type fatty acid-binding protein predicts long-term mortality after acute coronary syndrome and identifies high-risk patients across the range of troponin values. J Am Coll Cardiol. 2007 Nov 20;50(21):2061-7. doi: 10.1016/j.jacc.2007.08.021. Epub 2007 Nov 5.
Nabi F, Chang SM, Pratt CM, Paranilam J, Peterson LE, Frias ME, Mahmarian JJ. Coronary artery calcium scoring in the emergency department: identifying which patients with chest pain can be safely discharged home. Ann Emerg Med. 2010 Sep;56(3):220-9. doi: 10.1016/j.annemergmed.2010.01.017. Epub 2010 Feb 6.
Blaha MJ, Budoff MJ, DeFilippis AP, Blankstein R, Rivera JJ, Agatston A, O'Leary DH, Lima J, Blumenthal RS, Nasir K. Associations between C-reactive protein, coronary artery calcium, and cardiovascular events: implications for the JUPITER population from MESA, a population-based cohort study. Lancet. 2011 Aug 20;378(9792):684-92. doi: 10.1016/S0140-6736(11)60784-8.
Antman EM, Cohen M, Bernink PJ, McCabe CH, Horacek T, Papuchis G, Mautner B, Corbalan R, Radley D, Braunwald E. The TIMI risk score for unstable angina/non-ST elevation MI: A method for prognostication and therapeutic decision making. JAMA. 2000 Aug 16;284(7):835-42. doi: 10.1001/jama.284.7.835.
Conway Morris A, Caesar D, Gray S, Gray A. TIMI risk score accurately risk stratifies patients with undifferentiated chest pain presenting to an emergency department. Heart. 2006 Sep;92(9):1333-4. doi: 10.1136/hrt.2005.080226. No abstract available.
Mettler FA Jr, Huda W, Yoshizumi TT, Mahesh M. Effective doses in radiology and diagnostic nuclear medicine: a catalog. Radiology. 2008 Jul;248(1):254-63. doi: 10.1148/radiol.2481071451.
Rumberger JA, Brundage BH, Rader DJ, Kondos G. Electron beam computed tomographic coronary calcium scanning: a review and guidelines for use in asymptomatic persons. Mayo Clin Proc. 1999 Mar;74(3):243-52. doi: 10.4065/74.3.243.
Chan CP, Sum KW, Cheung KY, Glatz JF, Sanderson JE, Hempel A, Lehmann M, Renneberg I, Renneberg R. Development of a quantitative lateral-flow assay for rapid detection of fatty acid-binding protein. J Immunol Methods. 2003 Aug;279(1-2):91-100. doi: 10.1016/s0022-1759(03)00243-6.
Miller CD, Lindsell CJ, Anantharaman V, Lim SH, Greenway J, Pollack CV, Tiffany BR, Hollander JE, Gibler WB, Hoekstra JW; EMCREG-International i*trACS Investigators. Performance of a population-based cardiac risk stratification tool in Asian patients with chest pain. Acad Emerg Med. 2005 May;12(5):423-30. doi: 10.1197/j.aem.2004.11.016.
Kip KE, Hollabaugh K, Marroquin OC, Williams DO. The problem with composite end points in cardiovascular studies: the story of major adverse cardiac events and percutaneous coronary intervention. J Am Coll Cardiol. 2008 Feb 19;51(7):701-7. doi: 10.1016/j.jacc.2007.10.034.
Liao J, Chan CP, Cheung YC, Lu JH, Luo Y, Cautherley GW, Glatz JF, Renneberg R. Human heart-type fatty acid-binding protein for on-site diagnosis of early acute myocardial infarction. Int J Cardiol. 2009 Apr 17;133(3):420-3. doi: 10.1016/j.ijcard.2008.01.049. Epub 2008 Jun 20.
Chan CP, Sanderson JE, Glatz JF, Cheng WS, Hempel A, Renneberg R. A superior early myocardial infarction marker. Human heart-type fatty acid-binding protein. Z Kardiol. 2004 May;93(5):388-97. doi: 10.1007/s00392-004-0080-6.
Six AJ, Cullen L, Backus BE, Greenslade J, Parsonage W, Aldous S, Doevendans PA, Than M. The HEART score for the assessment of patients with chest pain in the emergency department: a multinational validation study. Crit Pathw Cardiol. 2013 Sep;12(3):121-6. doi: 10.1097/HPC.0b013e31828b327e.
Other Identifiers
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10110121
Identifier Type: -
Identifier Source: org_study_id
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