NCT02364271

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
602

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

April 15, 2021

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

1.6 years

First QC Date

February 3, 2015

Results QC Date

September 28, 2017

Last Update Submit

April 14, 2021

Conditions

Acute Coronary Syndrome

Keywords

High-sensitive troponinTIMI scoreMajor adverse cardiac eventHEART score

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Number of Safety Major Adverse Cardiac Event

    30 Days

  • Number of Effecacy MACE

    30 days

Study Arms (2)

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

Other: Thrombolysis in myocardial infarction scoreBiological: routine blood test for hs-cTnTOther: HEART score

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

Other: Thrombolysis in myocardial infarction scoreBiological: routine blood test for hs-cTnTOther: HEART score

Interventions

Thrombolysis in myocardial infarction scoreOTHER

An English- and Cantonese-speaking research nurse obtained the TIMI scores which consists of seven variables from each eligible patient.

Also known as: TIMI score
Low risk for MACE in 30 daysNot low risk for MACE in 30 days
routine blood test for hs-cTnTBIOLOGICAL

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.

Also known as: hs-cTnT
Low risk for MACE in 30 daysNot low risk for MACE in 30 days
HEART scoreOTHER

The modified HEART score of each patient was determined retrospectively by a research assistant.

Low risk for MACE in 30 daysNot low risk for MACE in 30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had chest or epigastric pain within 24 hours of emergency department presentation and suspected with acute coronary syndrome

You may qualify if:

  • Aged 18 years or over
  • Chest pain within 24 hours of ED presentation
  • Suspected with ACS

You may not qualify if:

  • No cardiac chest pain based on clinical assessment
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

Related Publications (17)

  • 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.

    PMID: 10770981BACKGROUND

  • 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.

    PMID: 15724574BACKGROUND

  • 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.

    PMID: 19007346BACKGROUND

  • 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.

    PMID: 20513600BACKGROUND

  • 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.

    PMID: 18021874BACKGROUND

  • 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.

    PMID: 20138399BACKGROUND

  • 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.

    PMID: 21856482BACKGROUND

  • 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.

    PMID: 10938172BACKGROUND

  • 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.

    PMID: 16908715BACKGROUND

  • 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.

    PMID: 18566177BACKGROUND

  • 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.

    PMID: 10089993BACKGROUND

  • 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.

    PMID: 12969550BACKGROUND

  • 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.

    PMID: 15863398BACKGROUND

  • 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.

    PMID: 18279733BACKGROUND

  • 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.

    PMID: 18571749BACKGROUND

  • 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.

    PMID: 15160274BACKGROUND

  • 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.

    PMID: 23892941BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Fibrinolytic Agents

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Fibrin Modulating AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesCardiovascular AgentsTherapeutic UsesHematologic Agents

Results Point of Contact

Title
Professor Timothy Rainer
Organization
Chinese University of Hong Kong
thrainer@cuhk.edu.hk
00 852 2632 1034

Study Officials

  • Timothy H Rainer, MD FCEM

    Accident & Emergency Medicine Academic Unit

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director & Professor

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 18, 2015

Study Start

March 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

April 15, 2021

Results First Posted

April 15, 2021

Record last verified: 2021-04

Locations

CN(1)