Acute Coronary SyndromeNCT02364271
Early Risk Stratification in ED Chest Pain Patients
An observational study of Acute Coronary Syndrome, run by Chinese University of Hong Kong at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Thrombolysis in myocardial infarction score, routine blood test for hs-cTnT and HEART score
- How many people
- 602 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Oct 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had chest or epigastric pain within 24 hours of emergency department presentation and suspected with acute coronary syndrome
Who may be able to join
- Aged 18 years or over
- Chest pain within 24 hours of ED presentation
- Suspected with ACS
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Early Risk Stratification in Patients Presenting to Emergency Departments With Undifferentiated Chest Pain
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.
Read the detailed description
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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Thrombolysis in myocardial infarction score, routine blood test for hs-cTnT, HEART score
- Keywords
- High-sensitive troponin, TIMI score, Major adverse cardiac event, HEART score
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombolysis in myocardial infarction scoreOther
Also called TIMI 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-cTnTBiological
Also called 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 scoreOther
The modified HEART score of each patient was determined retrospectively by a research assistant.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Thrombolysis in myocardial infarction score; Biological: routine blood test for hs-cTnT; Other: 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 Receives: Other: Thrombolysis in myocardial infarction score; Biological: routine blood test for hs-cTnT; Other: HEART score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (2)
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
Measured: 30 Days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startMar 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Food and Health Bureau, Hong Kong
- Responsible party
- Principal investigator, Timothy H Rainer, Chinese University of Hong Kong
- Investigators
- Timothy H Rainer, MD FCEM, Principal investigator, Accident & Emergency Medicine Academic Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364271
- Sponsor's protocol ID
- 10110121
- Status last verified
- Apr 2021
- First submitted
- 3 Feb 2015
- Last updated
- 15 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 10770981Chou 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.
PubMed 15724574Bernstein 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.
PubMed 19007346Viswanathan 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.
PubMed 20513600Kilcullen 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.
PubMed 18021874Nabi 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.
PubMed 20138399Blaha 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.
PubMed 21856482Antman 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.
PubMed 10938172Conway 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.
PubMed 16908715Mettler 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.
PubMed 18566177Rumberger 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.
PubMed 10089993Chan 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.
PubMed 12969550Miller 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.
PubMed 15863398Kip 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.
PubMed 18279733Liao 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.
PubMed 18571749
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Early Risk Stratification in Patients Presenting to Emergency Departments With Undifferentiated Chest Pain
- ClinicalTrials.gov ID
- NCT02364271
- Acronym / sponsor ID
- 10110121
- Conditions
- Acute Coronary Syndrome
- Keywords
- High-sensitive troponin, TIMI score, Major adverse cardiac event, HEART score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Food and Health Bureau, Hong Kong
- Study start
- Mar 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Posted 15 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Not low risk for MACE in 30 days | – | Other: Thrombolysis in myocardial infarction score, Biological: routine blood test for hs-cTnT, Other: HEART scorePatients 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 | – | Other: Thrombolysis in myocardial infarction score, Biological: routine blood test for hs-cTnT, Other: HEART scorePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had chest or epigastric pain within 24 hours of emergency department presentation and suspected with acute coronary syndrome
Key inclusion criteria (3 listed)
- Aged 18 years or over
- Chest pain within 24 hours of ED presentation
- Suspected with ACS
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrombolysis in myocardial infarction scoreAlso: TIMI scoreAn English- and Cantonese-speaking research nurse obtained the TIMI scores which consists of seven variables from each eligible patient. | Other | Low risk for MACE in 30 days, Not low risk for MACE in 30 days |
| routine blood test for hs-cTnTAlso: hs-cTnTPatient 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. | Biological | Low risk for MACE in 30 days, Not low risk for MACE in 30 days |
| HEART scoreThe modified HEART score of each patient was determined retrospectively by a research assistant. | Other | Low risk for MACE in 30 days, Not low risk for MACE in 30 days |
Primary outcome
Number of Patients With Major Adverse Cardiac Event
Time frame: 30 days
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.
2 secondary outcomes
Number of Safety Major Adverse Cardiac Event
Time frame: 30 Days
Number of Effecacy MACE
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10770981Pope 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.
- Background: PubMed 15724574Chou 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.
- Background: PubMed 19007346Bernstein 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.
- Background: PubMed 20513600Viswanathan 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.
- Background: PubMed 18021874Kilcullen 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.
- Background: PubMed 20138399Nabi 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.
- Background: PubMed 21856482Blaha 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.
- Background: PubMed 10938172Antman 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.
- Background: PubMed 16908715Conway 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.
- Background: PubMed 18566177Mettler 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.
- Background: PubMed 10089993Rumberger 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.
- Background: PubMed 12969550Chan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy H Rainer, MD FCEM principal investigator
Accident & Emergency Medicine Academic Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Major Adverse Cardiac Event (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02364271, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021; AzTrials last refreshed its copy on 26 Oct 2026.