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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chest Pain; Acute Coronary Syndrome; Heart Attack
• Intervention / Treatment: Other: Immediate discharge

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • Manchester University NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control (Routine Care); 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); 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; Participants discharged after initial blood test for cardiac troponin and risk stratification using the T-MACS decision aid

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Investigators: Principal Investigator: Richard Body, Manchester University NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: T-MACS
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Disease; Infarction; Myocardial Infarction; Syndrome; Chest Pain; Acute Coronary Syndrome
• Other Study ID Numbers: R04799; 245543 (Other Identifier: IRAS Project ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No