Early Risk Stratification in ED Chest Pain Patients

April 14, 2021 updated by: Timothy H Rainer, Chinese University of Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

602

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 score
An English- and Cantonese-speaking research nurse obtained the TIMI scores which consists of seven variables from each eligible patient.
Other Names:
  • TIMI score
Biological: 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.
Other Names:
  • hs-cTnT
Other: 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
Other: 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.
Other Names:
  • TIMI score
Biological: 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.
Other Names:
  • hs-cTnT
Other: HEART score
The modified HEART score of each patient was determined retrospectively by a research assistant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Safety Major Adverse Cardiac Event
Time Frame: 30 Days
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
Number of Effecacy MACE
Time Frame: 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Prince of Wales Hospital, Shatin, Hong Kong
Food and Health Bureau, Hong Kong

Investigators

  • Principal Investigator: Timothy H Rainer, MD FCEM, Accident & Emergency Medicine Academic Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 3, 2015

First Submitted That Met QC Criteria

February 10, 2015

First Posted (Estimate)

February 18, 2015

Study Record Updates

Last Update Posted (Actual)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10110121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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