TnThs Predicting Evolving Non-STEMI

High Sensitive Cardiac Troponin T for Early Prediction of Evolving Non-ST Segment Elevation Myocardial Infarction in Patients With Suspected Acute Coronary Syndrome and Negative Troponin Result on Admission

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00953251

Enrollment

115

Registered

2009-08-06

Start date

2008-05-31

Completion date

2008-12-31

Last updated

2009-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

high sensitive troponin T; non-STEMI; early detection., To detect non-STEMI in a cohort of patients with acute coronary syndrome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

Germany

Outcome results