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

Manchester University NHS Foundation Trust

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Heart Attack Chest Pain Acute Coronary Syndrome

Interventions

Immediate dischargeOTHER

Participants discharged after initial blood test for cardiac troponin and risk stratification using the T-MACS decision aid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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)

Locations (1)

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Outcomes

Primary Outcomes

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)

Time frame: 30 days

Secondary Outcomes

The incidence of coronary revascularization

If the participant has had a cardiac bypass or has had stents inserted to improve blood flow

Time frame: 30 days

Length of initial hospital stay

How long the participant was in hospital for after Emergency Department admission

Time frame: 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

Time frame: 1 year

Data from ClinicalTrials.gov

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