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

Primary Purpose

Heart Attack, Chest Pain, Acute Coronary Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Immediate discharge
Sponsored by
Manchester University NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Attack focused on measuring T-MACS

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Manchester University NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control (Routine Care)

Intervention (Immediate Discharge)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

The incidence of coronary revascularization
If the participant has had a cardiac bypass or has had stents inserted to improve blood flow
Length of initial hospital stay
How long the participant was in hospital for after Emergency Department admission
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

Full Information

First Posted
March 16, 2020
Last Updated
January 22, 2021
Sponsor
Manchester University NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04313465
Brief Title
T-MACS Decision Aid: a Randomized, Controlled Point of Care Trial
Official Title
Troponin-only Manchester Acute Coronary Syndromes Decision Aid to Reduce Unnecessary Hospitalisation for Patients With Chest Pain: a Randomized, Controlled Point of Care Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
CI no longer wishes to complete this study due to Covid-19
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manchester University NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Attack, Chest Pain, Acute Coronary Syndrome
Keywords
T-MACS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control (Routine Care)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention (Immediate Discharge)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Immediate discharge
Intervention Description
Participants discharged after initial blood test for cardiac troponin and risk stratification using the T-MACS decision aid
Primary Outcome Measure Information:
Title
The incidence of major adverse cardiac event
Description
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 Outcome Measure Information:
Title
The incidence of coronary revascularization
Description
If the participant has had a cardiac bypass or has had stents inserted to improve blood flow
Time Frame
30 days
Title
Length of initial hospital stay
Description
How long the participant was in hospital for after Emergency Department admission
Time Frame
30 days
Title
The incidence of cardiovascular death or acute myocardial infarction
Description
If the patient has had another cardiac episode, or if the participant has died due to a heart attack
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Body
Organizational Affiliation
Manchester University NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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