TnThs for Identification Myocardial Infarction

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT00950469
• Lead Sponsor: Heidelberg University

Brief Summary

OBJECTIVES/BACKGROUND: We sought to determine the early diagnostic value of the new high sensitive cardiac troponin T assay (TnThs) in suspected acute coronary syndrome (ACS) and to compare it with the 4th generation cTnT assay from the same manufacturer, myoglobin and heart-type fatty acid binding protein (h-FABP).

METHODS: The study consisted of 94 patients with chest pain admitted to the chest pain unit with the diagnosis of suspected ACS without ST-Elevation. Patients were divided according to time from onset of symptoms to presentation into an early presenter group (\<4 hours) and a late presenter group (≥4 hours).

A median of 6 samples (range 2-8) were available per patient. The diagnostic performance of TnThs was assessed using ROC analysis and areas under the curve (AUC) of baseline and follow-up results of TnThs, cTnT, myoglobin, and h-FABP were compared using c-statistics.

RESULTS: The TnThs assay allows an excellent prediction of non-ST-segment-elevation myocardial infarction (non-STEMI) at presentation.A follow-up sample improves diagnostic performance in a time dependent manner. The AUC of the TnThs was superior to cTnT at all time points.

CONCLUSIONS: A baseline sample of TnThs allows an earlier prediction of non-STEMI than the less sensitive and precise 4th generation cTnT assay. The excellent performance of TnThs at baseline and follow-up might obviate the need for other early necrosis markers.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-07
• Study First Submitted: 2009-07-30
• Study First Submitted QC: 2009-07-30
• Last Update Submitted: 2009-07-30
• Study First Posted: 2009-07-31
• Last Update Posted: 2009-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• consecutive patients with ACS

Exclusion Criteria

• Patients with ST-segment elevation at presentation were excluded as were patients with muscular trauma, or severe kidney dysfunction defined as an estimated glomerular filtration rate below 60 ml/min/1.73m2.
• In addition patients who underwent percutaneous coronary intervention during follow-up sampling were also excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the early diagnostic value of the new high sensitive cardiac troponin T assay (TnThs) for earlier detection of myocardial necrosis in suspected acute coronary syndrome.	6 to 24 hours after admission

Secondary Outcome Measures

Name	Time	Method
Comparison of TnThs with cTnT, myoglobin and h-FABP.	6 to 24 hours after admission

Trial Locations

Locations (1)

University of Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany