Acute Coronary Syndrome
Conditions
Keywords
High-sensitive troponin, TIMI score, Major adverse cardiac event, HEART score
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.
Interventions
OTHERThrombolysis in myocardial infarction score
An English- and Cantonese-speaking research nurse obtained the TIMI scores which consists of seven variables from each eligible patient.
BIOLOGICALroutine 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.
OTHERHEART score
The modified HEART score of each patient was determined retrospectively by a research assistant.
Sponsors
Prince of Wales Hospital, Shatin, Hong Kong
Food and Health Bureau, Hong Kong
Chinese University of Hong Kong
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Major Adverse Cardiac Event | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Safety Major Adverse Cardiac Event | 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 |
| Number of Effecacy MACE | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 479 |
| 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 | 123 |
| Total | 602 |
Baseline characteristics
| Characteristic | High Risk Group | Low Risk Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 314 Participants | 7 Participants | 321 Participants |
| Age, Categorical Between 18 and 65 years | 165 Participants | 116 Participants | 281 Participants |
| Age, Continuous | 66.5 years | 66 years | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 479 Participants | 123 Participants | 602 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 42 participants | 560 participants | 602 participants |
| Sex: Female, Male Female | 241 Participants | 67 Participants | 308 Participants |
| Sex: Female, Male Male | 238 Participants | 56 Participants | 294 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 479 | 0 / 123 |
| other Total, other adverse events | 9 / 479 | 0 / 123 |
| serious Total, serious adverse events | 26 / 479 | 0 / 123 |
Outcome results
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.
Time frame: 30 days
Population: 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Not Low Risk Groups | Number of Patients With Major Adverse Cardiac Event | MACE within 30 days | 42 Participants |
| Not Low Risk Groups | Number of Patients With Major Adverse Cardiac Event | No MACE within 30 days | 437 Participants |
| Low Risk Group | Number of Patients With Major Adverse Cardiac Event | MACE within 30 days | 0 Participants |
| Low Risk Group | Number of Patients With Major Adverse Cardiac Event | No MACE within 30 days | 123 Participants |
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.
Time frame: 30 days
Population: Patient had MACE within 3 months of initial presentation for chest pain in ED
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Not Low Risk Groups | Number of Effecacy MACE | 26 Participants |
| Low Risk Group | Number of Effecacy MACE | 0 Participants |
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
Time frame: 30 Days
Population: Patients with major adverse cardiac events occurred within 30-days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Not Low Risk Groups | Number of Safety Major Adverse Cardiac Event | 31 Participants |
| Low Risk Group | Number of Safety Major Adverse Cardiac Event | 0 Participants |