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Recruitment Status : Withdrawn (CI no longer wishes to complete this study due to Covid-19)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
|Condition or disease||Intervention/treatment||Phase|
|Heart Attack Chest Pain Acute Coronary Syndrome||Other: Immediate discharge||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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
- 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)
- 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
- Length of initial hospital stay [ Time Frame: 30 days ]How long the participant was in hospital for after Emergency Department admission
- 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
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
|Manchester University NHS Foundation Trust|
|Manchester, United Kingdom|
|Principal Investigator:||Richard Body||Manchester University NHS Foundation Trust|