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

Sponsor
Herlev Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04087538
Collaborator
(none)
300
2
33
150
4.5

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Troponin T and I

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Comparison of Cardiac Troponin T and Troponin I in the Diagnosis of Myocardial Infarction
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. 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

  2. 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

  3. Number of MIs [0]

    The difference in the number of patients diagnosed with MI for each cardiac Troponin

  4. PPV and NPV [0]

    The difference in positive predictive value and negative predictive value of each cardiac Troponin

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bispebjerg Hospital Bispebjerg Copenhagen Denmark 2400
2 Herlev-Gentofte Hospital Herlev Denmark 2730

Sponsors and Collaborators

  • Herlev Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rasmus Bo Hasselbalch, MD, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT04087538
Other Study ID Numbers:
  • 19000557
First Posted:
Sep 12, 2019
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rasmus Bo Hasselbalch, MD, Herlev Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022