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

Recruiting

• Conditions: Myocardial Infarction
• Interventions: Diagnostic Test: Troponin T and I

• Registration Number: NCT04087538
• Lead Sponsor: Herlev Hospital

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-12
• Study Start: 2021-07-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05
• Primary Completion: 2023-10-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated using troponin I	Troponin T and I	-
Patients treated using troponin T	Troponin T and I	-

Primary Outcome Measures

Name	Time	Method
Specificity for MI	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	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 Outcome Measures

Name	Time	Method
Sensitivity for MI	0	A safety outcome of difference in sensitivity of cardiac Troponin T and cardiac Troponin I in the detection of patients with significant coronary artery disease. The sensitivity is defined as the proportion of patients with significant coronary artery disease that were referred to ICA upon review by the senior cardiologists
Elevated troponin without CAD	0	The difference in the proportion of patients with elevated cardiac Troponin T or cardiac Troponin I above the 99th percentile with no significant CAD on ICA
Number of MIs	0	The difference in the number of patients diagnosed with MI for each cardiac Troponin
PPV and NPV	0	The difference in positive predictive value and negative predictive value of each cardiac Troponin

Trial Locations

Locations (2)

Bispebjerg Hospital; 🇩🇰 Bispebjerg, Copenhagen, Denmark

Herlev-Gentofte Hospital; 🇩🇰 Herlev, Denmark