T-MACS Decision Aid: a Randomized, Controlled Point of Care Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Troponin-only Manchester Acute Coronary Syndromes Decision Aid to Reduce Unnecessary Hospitalisation for Patients With Chest Pain: a Randomized, Controlled Point of Care Trial

Conditions
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Heart Attack, Chest Pain, Acute Coronary Syndrome

Intervention / Treatment
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* Other: Immediate discharge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age Presents to the Emergency Department with pain, discomfort or pressure in the chest, epigastrium, neck, jaw, or upper limb without an apparent non-cardiac source which the treating physician believes warrants investigation for possible acute coronary syndrome The patient is identified as being at 'very low risk' by the T-MACS decision aid following a single hs-cTn test at the time of arrival in the Emergency Department Exclusion Criteria: No capacity to provide informed consent Inability to communicate in English language if translation services are unavailable Patient is a prisoner No NHS number (precluding electronic follow up)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control (Routine Care)<br>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. | |
| Experimental: Intervention (Immediate Discharge)<br>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. | Other: Immediate discharge<br>* Participants discharged after initial blood test for cardiac troponin and risk stratification using the T-MACS decision aid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T-MACS