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

NCT04313465 | Withdrawn DMC

• 2 other identifiers: R04799245543
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Attack; Chest Pain; Acute Coronary Syndrome

Keywords

T-MACS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The incidence of coronary revascularization

  30 days

• Length of initial hospital stay

  30 days

• The incidence of cardiovascular death or acute myocardial infarction

  1 year

Study Arms (2)

Control (Routine Care)

NO INTERVENTION

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.

Intervention (Immediate Discharge)

EXPERIMENTAL

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

Interventions

Immediate discharge OTHER

Participants discharged after initial blood test for cardiac troponin and risk stratification using the T-MACS decision aid

Intervention (Immediate Discharge)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Myocardial Infarction; Chest Pain; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Richard Body

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: January 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)