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

Not Applicable

Withdrawn

• Conditions: Chest Pain; Heart Attack; Acute Coronary Syndrome
• Interventions: Other: Immediate discharge

• Registration Number: NCT04313465
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-18
• Status Verified: 2021-01
• Study Start: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-26
• Primary Completion: 2021-06
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (Immediate Discharge)	Immediate discharge	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.

Primary Outcome Measures

Name	Time	Method
The incidence of major adverse cardiac event	30 days	This is defined as cardiovascular death or acute myocardial infarction (including prevalent acute myocardial infarction at the time of initial attendance)

Secondary Outcome Measures

Name	Time	Method
The incidence of cardiovascular death or acute myocardial infarction	1 year	If the patient has had another cardiac episode, or if the participant has died due to a heart attack
Length of initial hospital stay	30 days	How long the participant was in hospital for after Emergency Department admission
The incidence of coronary revascularization	30 days	If the participant has had a cardiac bypass or has had stents inserted to improve blood flow

Trial Locations

Locations (1)

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom