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| Name | Class |
|---|---|
| Prince of Wales Hospital, Shatin, Hong Kong | OTHER |
| Food and Health Bureau, Hong Kong | OTHER_GOV |
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In the management of adult chest pain patients presenting to an Emergency Department (ED) with suspected acute coronary syndrome (ACS), we aimed to evaluate the diagnostic accuracy of the combined use of a modified Thrombolysis in Myocardial Infarction (TIMI) score and a modified HEART score with high-sensitive cardiac troponin T (hs-cTnT) to rule out major adverse cardiac events (MACE) in 30-days.
Chest pain is one of the most common complaints in patients presenting to emergency departments (ED) globally, representing 2.5% of all ED presentations in Hong Kong. Acute coronary syndrome (ACS) cannot be immediately excluded in the majority of patients presenting with chest pain, and is confirmed in about 15-25% cases. The current evaluation of patients in most EDs is a lengthy process that involves serial ECGs and troponin tests taken 3-6 hours apart. However, challenges over ED crowding and the need for acceptable risk stratification have prompted the search for safe, cheap, but effective accelerated chest pain pathways.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombolysis in myocardial infarction score | Other | An English- and Cantonese-speaking research nurse obtained the TIMI scores which consists of seven variables from each eligible patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Major Adverse Cardiac Event | The primary outcome is the number of patients with MACE within 30 days after initial ED presentation. MACE is defined as relating to safety outcome, or effecacy outcome. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Safety Major Adverse Cardiac Event | Outcome is the number of patients with safety MACE within 30 days after initial ED presentation. Safety MACE is defined as relating to safety outcome,which consists of all-cause mortality (included cardiac death),cardiac arrest,readmission with myocardial infarction and cardiogenic shock | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who had chest or epigastric pain within 24 hours of emergency department presentation and suspected with acute coronary syndrome
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| Name | Affiliation | Role |
|---|---|---|
| Timothy H Rainer, MD FCEM | Accident & Emergency Medicine Academic Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10770981 | Background | 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. | |
| 15724574 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Not Low Risk Group | Routine blood test for hs-cTnT, Thrombolysis in myocardial infarction score (TIMI) and mHEART score were performed on study patients. TIMI>0 and mHEART>2 |
| FG001 | Low Risk Group | Routine blood test for hs-cTnT, Thrombolysis in myocardial infarction score (TIMI) and mHEART score were performed on study patients. TIMI=0 or mHEART<=2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Risk Group | Routine blood test for hs-cTnT, Thrombolysis in myocardial infarction score (TIMI) and mHEART score were performed on study patients. TIMI>0 and mHEART>2 |
| BG001 | Low Risk Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Major Adverse Cardiac Event | The primary outcome is the number of patients with MACE within 30 days after initial ED presentation. MACE is defined as relating to safety outcome, or effecacy outcome. | This is not an interventional trial. This prospective observational study to assess the efficiency of combining TIMI and HEART score in early exclusion of major adverse cardiac events in emergency department patients with chest pain | Posted | Count of Participants | Participants | 30 days |
|
30 days
Major adverse cardiac events encompass both safety and effecacy elements. Safety outcomes consist of all-cause mortality (including cardiac death), cardiac arrest, myocardial infarction and cardiogenic shock. Effecacy outcomes consist of revascularization (e.g. coronary artery bypass grafting or percutaneous coronary intervention), ventricular arrhythmia needing intervention and high-degree atrioventricular block needing intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Not Low Risk Group | Patients with modified TIMI>0 and modified HEART>2 were considered as high risk for 30-day MACE. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Safety MACE (STEMI) | Cardiac disorders | Systematic Assessment | Patients had STEMI and survived. 7 had percutaneous coronary intervention or coronary artery bypass grafting |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Effectiveness MACE (PCI) | Surgical and medical procedures | Percutaneous coronary intervention without prior serious adverse cardiac event. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Timothy Rainer | Chinese University of Hong Kong | 00 852 2632 1034 | thrainer@cuhk.edu.hk |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D005343 | Fibrinolytic Agents |
| ID | Term |
|---|---|
| D050299 | Fibrin Modulating Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| routine blood test for hs-cTnT | Biological | 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. |
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| HEART score | Other | The modified HEART score of each patient was determined retrospectively by a research assistant. |
|
| Number of Effecacy MACE | Outcome is the number of patients with effecacy MACE within 30 days after initial ED presentation. Effecacy MACE consists of revascularization (e.g.coronary artery bypass grafting),ventricular arrhythmia needing intervention and high-degree atrioventricular block needing intervention. | 30 days |
| 19007346 | Background | 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. |
| 20513600 | Background | 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. |
| 18021874 | Background | 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. |
| 20138399 | Background | 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. |
| 21856482 | Background | 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. |
| 10938172 | Background | 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. |
| 16908715 | Background | 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. |
| 18566177 | Background | 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. |
| 10089993 | Background | 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. |
| 12969550 | Background | 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. |
| 15863398 | Background | 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. |
| 18279733 | Background | 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. |
| 18571749 | Background | 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. |
| 15160274 | Background | 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. |
| 23892941 | Background | 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. |
Routine blood test for hs-cTnT, Thrombolysis in myocardial infarction score (TIMI) and mHEART score were performed on study patients. TIMI=0 or mHEART<=2
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Low Risk Group | Patients with modified TIMI=0 or modified HEART<=2 were considered as low risk for 30-day MACE. Modified TIMI and HEART scores included hs-cTnT tests as opposed to conventional cTnT in the original tests. The presence of any ST-deviation of >0.05mV in the initial ECG was considered a positive result. A negative hs-cTnT result was defined as a concentration of ≤14ng/L. |
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| Secondary | Number of Safety Major Adverse Cardiac Event | Outcome is the number of patients with safety MACE within 30 days after initial ED presentation. Safety MACE is defined as relating to safety outcome,which consists of all-cause mortality (included cardiac death),cardiac arrest,readmission with myocardial infarction and cardiogenic shock | Patients with major adverse cardiac events occurred within 30-days | Posted | Count of Participants | Participants | 30 Days |
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|
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| Secondary | Number of Effecacy MACE | Outcome is the number of patients with effecacy MACE within 30 days after initial ED presentation. Effecacy MACE consists of revascularization (e.g.coronary artery bypass grafting),ventricular arrhythmia needing intervention and high-degree atrioventricular block needing intervention. | Patient had MACE within 3 months of initial presentation for chest pain in ED | Posted | Count of Participants | Participants | 30 days |
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| 5 |
| 479 |
| 26 |
| 479 |
| 9 |
| 479 |
| EG001 | Low Risk Group | Patients with modified TIMI=0 or modified HEART<=2 were considered as low risk for 30-day MACE. | 0 | 123 | 0 | 123 | 0 | 123 |
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| Safety MACE (NSTEMI) | Cardiac disorders | Systematic Assessment | Patients had NSTEMI and survived. 10 had percutaneous coronary intervention or coronary artery bypass grafting |
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| Effectiveness MACE (CABG) | Surgical and medical procedures | Coronary artery bypass grafting without prior serious adverse cardiac event |
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| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D006401 | Hematologic Agents |