Development and validation of a tool to rule out heart attacks

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001441404
• Date of registration: 14/10/2016
• Prospective Registration: No
• Primary sponsor: Dr Martin Than
• Public title: Development and validation of a tool to rule out heart attacks
• Scientific title: Development and validation of a multivariable prediction model to risk stratify patients being investigated for possible Acute Myocardial Infarction in the Emergency Department.
• Date of first enrolment: 01/04/2006
• Target sample size: 5000
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001441404.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Cross-sectional;Selection: Defined population;Timing: Retrospective;
• Phase: Not Applicable

Countries of recruitment

Australia, Germany, New Zealand, Switzerland, United Kingdom, United States of America

Contacts

• Name: Dr Martin Than

• Name: Dr Martin Than

Key inclusion & exclusion criteria

Inclusion criteria: Patients investigated for possible ACS in the cohorts described ( BACC (Hamburg, HighSTEACS (Edinburgh), UTROPIA (Minneapolis), APACE (Basal), ADAPT-Brisbane, IMPACT (Brisbane, ADAPT-Christchurch, TIMIRCT, EDACSRCT (Christchurch))

The MI3 tool was applied in the validation cohort to assess its ability to predict outcomes recorded in medical records/previous studies.
Serial (two) hs-cTnI troponin measurements. The first made on arrival in the Emergency Department.
Exclusion criteria: STEMI diagnosed within the ED
Missing data on sex, age, timing of two consecutive blood samples, high sensitivity cardiac troponin I.
The universal definition not used to adjudicate for AMI
Cohorts without adjudicated outcomes



Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cardiovascular - Coronary heart disease

Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

Acute Myocardial Infarction;Acute Coronary Syndrome;
Acute Myocardial Infarction
Acute Coronary Syndrome

Intervention(s)

Observational study: Patients presenting to Emergency Departments with symptoms suggestive of Acute Coronary Syndrome are assessed for possible Type I Acute Myocardial Infarction
A retrospective analysis of previously collected data. Patients were participating in studies designed to assess the effectiveness of methodologies and biochemistry to rule-out and rule-in acute myocardial infarction.
The MI3 tool is a an algorithm developed from Age, Sex, serial troponin measurements, and the time between the troponin measurements. It is designed to provide clinicians with an indication of the likelihood of an acute myocardial infarction. It was applied only retrospectively on the validation cohort.

Derivation Cohorts
BACC (Hamburg): July 2013 to December 2014
HighSTEACS (Edinburgh): NCT01852123 June 2013 to January 2014
Machine learning was used to derive the MI3 tool to predict events as recorded in the medical records (and previous studies).

Validation cohorts
UTROPIA (Minneapolis)
APACE (Basal): April 2006 to June 2013
ADAPT-Brisbane (Brisbane): ACTRN12611001069943 November 2007 to February 2011
IMPACT (Brisbane): February 2011 to March 2014
ADAPT-Christchurch (Christchurch): ACTRN12611001069943 November 2007 to February 2011
TIMIRCT (Christchurch): ACTRN12610000766011 October 2010 to July 2012
EDACSRCT (Christchurch): ACTRN12613000745741 June 2013 to July 2014

The MI3 tool was applied in the validation cohort to assess its ability to predict outcomes recorded in medical records/previous studies.

Primary Outcome(s)

Probability of Type I AMI as assessed by the MI3 tool[index presentation]

Secondary Outcome(s)

Probability of Type I AMI as assessed by the MI3 tool[ within 30 days of presentation to the ED]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Abbott Diagnostics

Emergency Care Foundation