Clinical trial NCT04313465: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Attack
Chest Pain
Acute Coronary Syndrome
Keywords: T-MACS
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2020-03-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: The incidence of major adverse cardiac event
timeFrame: 30 days
Secondary outcomes:
measure: The incidence of coronary revascularization
timeFrame: 30 days
measure: Length of initial hospital stay
timeFrame: 30 days
measure: The incidence of cardiovascular death or acute myocardial infarction
timeFrame: 1 year
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: Richard Body
role: PRINCIPAL_INVESTIGATOR
References: