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

June 2, 2023 updated by: Rasmus Bo Hasselbalch, Herlev Hospital
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Two large acute medical centers will include patients for this study, one that routinely use cTnT (Hvidovre Hospital) and one that routinely uses cTnI (Herlev Hospital).

Each center will include consecutive patients over a period of 5 months clinically suspected of non-ST segment elevation myocardial infarction (NSTEMI). These patients will undergo serial measurement of either cardiac troponin T (cTnT) or cardiac troponin I (cTnI) as is standard practice. In addition to regular their lab tests, all patients will have extra blood samples set aside for a biobank.

At the end of the inclusion period, all patients sent to invasive coronary angiography (ICA) will be identified and included in the further analyses. As one center uses cTnT and one uses cTnI, patients will have either biomarker measured upon admission. The other cTn assay will be measured on all samples from the biobank, so every patient has at least one measurement of both cTnT and cTnI.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients treated using troponin T
Diagnostic test: Troponin T and I
Does the use of troponin T or I increase the number of patients referred to coronary angiography
Patients treated using troponin I
Diagnostic test: Troponin T and I
Does the use of troponin T or I increase the number of patients referred to coronary angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Specificity for MI
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
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

Outcome Measure
Measure Description
Sensitivity for MI
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
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
The difference in the number of patients diagnosed with MI for each cardiac Troponin
PPV and NPV
The difference in positive predictive value and negative predictive value of each cardiac Troponin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

September 11, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19000557

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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