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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04087538
• Other study ID #: 19000557
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: June 2023
• Source: Herlev Hospital
• Contact: Kasper Iversen, Dmsc
• Phone: 28712753
• Email: Kasper.karmark.iversen[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Diagnostic Test:
• Troponin T and I
Does the use of troponin T or I increase the number of patients referred to coronary angiography

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Bispebjerg	Copenhagen
Denmark	Herlev-Gentofte Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0
Primary	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.	0
Secondary	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	0
Secondary	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	0
Secondary	Number of MIs	The difference in the number of patients diagnosed with MI for each cardiac Troponin	0
Secondary	PPV and NPV	The difference in positive predictive value and negative predictive value of each cardiac Troponin	0