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| ID | Type | Description | Link |
|---|---|---|---|
| 245543 | Other Identifier | IRAS Project ID |
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CI no longer wishes to complete this study due to Covid-19
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The aim of the study is to establish whether the safety of the T-MACS decision aid to immediately 'rule out' acute coronary syndromes with one blood sample for the cardiac damage marker troponin, is non-inferior to an approach requiring serial troponin sampling over three hours.
We will conduct a randomized, controlled point of care trial embedded in routine practice. We will ask clinicians to obtain written informed consent during the course of their clinical duties. Patients who have suspected cardiac chest pain, who are identified as being at very low risk by the T-MACS algorithm, will be invited to participate.
Patients will then be randomly allocated to be advised that they can be discharged immediately (so long as the doctor and patient have no other concerns; this is the originally intended use of T-MACS; intervention arm) or to receive a second blood test after 3 hours (current practice; control arm).
Participants will then be followed up by electronic record review after 30 days and 12 months. Other than the difference in the requirement for a second blood test, participants will not notice any change to their care.
The accelerated pathway (involving a single blood test) has been shown to be safe in observational research involving over 5,000 patients. All of the data that are collected are the same of those that are collected in routine care, and they will be anonymised for analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (Routine Care) | No Intervention | Participants will undergo risk stratification using the T-MACS decision aid, which includes a cardiac troponin blood test upon admission to the Emergency Department. Participants will then have a repeat cardiac troponin blood test in 3 hours. | |
| Intervention (Immediate Discharge) | Experimental | Participants will undergo risk stratification using the T-MACS decision aid, which includes a troponin blood test upon admission to the Emergency Department. Participants will then be discharged. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate discharge | Other | Participants discharged after initial blood test for cardiac troponin and risk stratification using the T-MACS decision aid |
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| Measure | Description | Time Frame |
|---|---|---|
| The incidence of major adverse cardiac event | This is defined as cardiovascular death or acute myocardial infarction (including prevalent acute myocardial infarction at the time of initial attendance) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of coronary revascularization | If the participant has had a cardiac bypass or has had stents inserted to improve blood flow | 30 days |
| Length of initial hospital stay | How long the participant was in hospital for after Emergency Department admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Body | Manchester University NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manchester University NHS Foundation Trust | Manchester | United Kingdom |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D002637 | Chest Pain |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 30 days |
| The incidence of cardiovascular death or acute myocardial infarction | If the patient has had another cardiac episode, or if the participant has died due to a heart attack | 1 year |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |