Development and validation of a tool to rule out heart attacks

Development and validation of a multivariable prediction model to risk stratify patients being investigated for possible Acute Myocardial Infarction in the Emergency Department.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12616001441404

Enrollment

101540

Registered

2016-10-14

Start date

2006-04-01

Completion date

2014-12-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A multi-centre international diagnostic biomarker development and validation study using a secondary analysis of data prospectively collected from multiple cohorts. The overall project objective: To develop and validate an assessment algorithm that allows: 1. The early rule in of AMI for as many patients was possible with a low false positive rate. 2. The early rule out of acute myocardial infarction (AMI) for a large proportion of patients with a very low false negative rate The overall aims are: 1. To derive and validate the Myocardial Ischaemic Injury Index (MI3) for identification of patients with acute myocardial infarction amongst patients being investigated for possible acute coronary syndrome. 2. To derive and validate Index Value thresholds for optimal (i) rule-out and (ii) rule-in of acute myocardial infarction with the MI3 algorithm for rapid assessment of patients being investigated for possible acute coronary syndrome.

Interventions

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.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results