An observational study in Acute Coronary Syndrome, sponsored by Chinese University of Hong Kong. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-15.
Sponsored by Chinese University of Hong Kong · Observational
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.
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.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's enrollment of 602 is above the median of 500 across 561 observational studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who had chest or epigastric pain within 24 hours of emergency department presentation and suspected with acute coronary syndrome
Exclusion Criteria:
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 · Biological: routine blood test for hs-cTnT · Other: HEART score
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 · Biological: routine blood test for hs-cTnT · Other: HEART score
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
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
The modified HEART score of each patient was determined retrospectively by a research assistant.
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
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
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
| Milestone | Not Low Risk Group | Low Risk Group |
|---|---|---|
| Started | 479 | 123 |
| Completed | 479 | 123 |
| Not completed | 0 | 0 |
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.
| Participants | Not Low Risk Groups | Low Risk Group |
|---|---|---|
| MACE within 30 days | 42 | 0 |
| No MACE within 30 days | 437 | 123 |
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
| Participants | Not Low Risk Group | Low Risk Group |
|---|---|---|
| Number of Safety Major Adverse Cardiac Event | 31 | 0 |
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.
| Participants | Not Low Risk Group | Low Risk Group |
|---|---|---|
| Number of Effecacy MACE | 26 | 0 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Not Low Risk Group | 5/479 (1%) | 26/479 (5.4%) | 9/479 (1.9%) |
| Low Risk Group | 0/123 (0%) | 0/123 (0%) | 0/123 (0%) |
| Event | Not Low Risk Group | Low Risk Group |
|---|---|---|
| Safety MACE (NSTEMI)Cardiac disorders | 16/479 | 0/123 |
| Safety MACE (STEMI)Cardiac disorders | 10/479 | 0/123 |
| Event | Not Low Risk Group | Low Risk Group |
|---|---|---|
| Effectiveness MACE (PCI)Surgical and medical procedures | 7/479 | 0/123 |
| Effectiveness MACE (CABG)Surgical and medical procedures | 2/479 | 0/123 |
| Age, Categorical(Participants) | High Risk Group | Low Risk Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 165 | 116 | 281 |
| >=65 years | 314 | 7 | 321 |
| Age, Continuous(years) | High Risk Group | Low Risk Group | Total |
|---|---|---|---|
| Median | 66.5 (57.5 to 78) | 66 (56 to 78) | 66 (56 to 78) |
| Sex: Female, Male(Participants) | High Risk Group | Low Risk Group | Total |
|---|---|---|---|
| Female | 241 | 67 | 308 |
| Male | 238 | 56 | 294 |
| Ethnicity (NIH/OMB)(Participants) | High Risk Group | Low Risk Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 479 | 123 | 602 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | High Risk Group | Low Risk Group | Total |
|---|---|---|---|
| China | 42 | 560 | 602 |
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong