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

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ClinicalTrials.gov Identifier: NCT04313465
Recruitment Status : Withdrawn (CI no longer wishes to complete this study due to Covid-19)
First Posted : March 18, 2020
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Heart Attack Chest Pain Acute Coronary Syndrome Other: Immediate discharge Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

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




Primary Outcome Measures :
  1. The incidence of major adverse cardiac event [ Time Frame: 30 days ]
    This is defined as cardiovascular death or acute myocardial infarction (including prevalent acute myocardial infarction at the time of initial attendance)


Secondary Outcome Measures :
  1. The incidence of coronary revascularization [ Time Frame: 30 days ]
    If the participant has had a cardiac bypass or has had stents inserted to improve blood flow

  2. Length of initial hospital stay [ Time Frame: 30 days ]
    How long the participant was in hospital for after Emergency Department admission

  3. The incidence of cardiovascular death or acute myocardial infarction [ Time Frame: 1 year ]
    If the patient has had another cardiac episode, or if the participant has died due to a heart attack



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04313465


Locations
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United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Sponsors and Collaborators
Manchester University NHS Foundation Trust
Investigators
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Principal Investigator: Richard Body Manchester University NHS Foundation Trust
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Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04313465    
Other Study ID Numbers: R04799
245543 ( Other Identifier: IRAS Project ID )
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manchester University NHS Foundation Trust:
T-MACS
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Infarction
Syndrome
Chest Pain
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations