TnThs Predicting Evolving Non-STEMI

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT00953251
• Lead Sponsor: Heidelberg University

Brief Summary

BACKGROUND: We sought to determine the diagnostic value of the new TnThs assay for early detection of evolving non-STEMI in patients with acute coronary syndrome and a negative 4th generation cTnT result on admission.

METHODS: We evaluated several statistical patterns of blood results of TnT hs and cTnT of 115 patients and calculated necessity of prediction of evolving non-STEMI within 6 hours.

RESULTS: Based on the results of the 4th generation cTnT assay, an evolving non-STEMI was diagnosed in 26 patients, 31 were classified as unstable angina. The TnThs lead to an increase of non-STEMI diagnosis as compared to the 4th generation assay. We could calculate increased sensitivities for earlier detection of evolving non-STEMI from 61.5% on admission to 90.9% within 3 hours and 100% within 6 hours compared to cTnT.

CONCLUSIONS: The TnThs assay enables earlier detection of non-STEMI and allows identification of an additional percentage of cases with non-STEMI previously classified as unstable angina.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-08
• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-05
• Last Update Submitted: 2009-08-05
• Study First Posted: 2009-08-06
• Last Update Posted: 2009-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• 115 consecutive patients were enrolled with symptoms suggestive of ACS, admitted to the Chest Pain Unit of the University of Heidelberg. All patients received a 12-lead electrocardiogram (ECG) recording on admission, and a second 12-lead ECG after 6 hours

Exclusion Criteria

• Patients who underwent percutaneous coronary intervention (PCI) during follow-up sampling were excluded as were patients with a significant kidney dysfunction defined as an estimated glomerular filtration rate below 60 ml/min/1.73m2.
• Patients with STEMI were excluded.
• Patients with only 1 blood sample were also excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to determine the diagnostic accuracy of the new TnThs in subsequent blood draws for earlier detection of evolving non-STEMI in a nonselected population of patients presenting with ischemic symptoms suggestive of ACS.	within 6 hours after admission

Trial Locations

Locations (1)

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