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Clinical Trials/NCT04087538
NCT04087538RecruitingNot Applicable

A Prospective Comparison of Cardiac Troponin T and Troponin I in the Diagnosis of Myocardial Infarction

Herlev Hospital2 sites in 1 country300 target enrollmentStarted: July 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
300
Locations
2
Primary Endpoint
Specificity for MI

Study Overview

Brief Summary

The rising number of patients with chest pain without myocardial infarction has made accurate diagnosis important. Unnecessary invasive coronary angiographies are increasingly prevalent. These are both costly and lead to rare but serious adverse events. Recent studies suggest cardiac Troponin I is more cardiac specific than cardiac Troponin T. In this study we will investigate whether using cardiac Troponin I lead to fewer unnecessary procedures in clinical practice (i.e. invasive coronary angiography and non-invasive tests)

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Admitted to either Herlev-Gentofte or Amager-Hvidovre Hospital
  • Clinically suspected of NSTEMI
  • Referred to invasive coronary angiography (ICA)
  • Recieved at least one measurement of either troponin

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Specificity for MI

Time Frame: 0

The difference in specificity of cardiac Troponin and I in detecting patients with significant CAD. The specificity will be defined as the proportion of patients with no significant CAD on ICA correctly identified as low-risk patients and not referred to ICA upon the review by the senior cardiologists

Cost-effectiveness

Time Frame: 0

The cost-effectiveness of using cardiac Troponin T compared to cardiac Troponin I. This will be defined by the number of patients sent to ICA and the associated costs of this.

Secondary Outcomes

  • Sensitivity for MI(0)
  • Elevated troponin without CAD(0)
  • Number of MIs(0)
  • PPV and NPV(0)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rasmus Bo Hasselbalch

MD

Herlev Hospital

Study Sites (2)

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