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

Acute Coronary Syndrome Clinical 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04313465
• Other study ID #: R04799
• Secondary ID: 245543
• Status: Withdrawn
• Phase: N/A
• Start date: January 2021
• Est. completion date: August 2021

Study information

• Verified date: January 2021
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain
• Heart Attack
• Myocardial Infarction
• Syndrome

Intervention

Other:
• Immediate discharge
Participants discharged after initial blood test for cardiac troponin and risk stratification using the T-MACS decision aid

Locations

Country	Name	City	State
United Kingdom	Manchester University NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The incidence of coronary revascularization	If the participant has had a cardiac bypass or has had stents inserted to improve blood flow	30 days
Secondary	Length of initial hospital stay	How long the participant was in hospital for after Emergency Department admission	30 days
Secondary	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