Clinical trial NCT02364271: Early Risk Stratification in ED Chest Pain Patients
Official title: Improving Early Risk Stratification in Patients Presenting to Emergency Departments With Undifferentiated Chest Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: High-sensitive troponin
TIMI score
Major adverse cardiac event
HEART score
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Prince of Wales Hospital, Shatin, Hong Kong
name: Food and Health Bureau, Hong Kong
First posted: 2015-02-18
Enrollment: 602
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Major Adverse Cardiac Event
timeFrame: 30 days
Secondary outcomes:
measure: Number of Safety Major Adverse Cardiac Event
timeFrame: 30 Days
measure: Number of Effecacy MACE
timeFrame: 30 days
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
Study officials:
affiliation: Accident & Emergency Medicine Academic Unit
name: Timothy H Rainer, MD FCEM
role: PRINCIPAL_INVESTIGATOR
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