TnThs Predicting Evolving Non-STEMI - Full Text View

Purpose

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.

Condition
Acute Coronary Syndrome


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	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

Further study details as provided by Heidelberg University:

Primary Outcome Measures:

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. [ Time Frame: within 6 hours after admission ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Blood samples were collected on admission and ideally every hour within the initial 6 hours after admission, unless the patient refused the blood draw, or venipuncture was not feasible due to technical reasons.

After collection, blood samples were centrifuged immediately and serum stored at -80°C until analysis. The laboratory staff responsible for measurements was blinded to patient data.


Enrollment:	115
Study Start Date:	May 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
patients with acute coronary syndrome patients with acute coronary syndrome
Non-STEMI and unstable angina

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Between May 2008 and December 2008, 115 consecutive patients were enrolled with symptoms suggestive of ACS. All patients received a 12-lead electrocardiogram recording on admission, and a second 12-lead ECG after 6 hours. Blood samples were collected on admission and ideally every hour within the initial 6 hours after admission.

Criteria

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.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00953251

Locations


Germany
University of Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120

Sponsors and Collaborators

Heidelberg University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Giannitsis E, Kehayova T, Vafaie M, Katus HA. Combined testing of high-sensitivity troponin T and copeptin on presentation at prespecified cutoffs improves rapid rule-out of non-ST-segment elevation myocardial infarction. Clin Chem. 2011 Oct;57(10):1452-5. doi: 10.1373/clinchem.2010.161265. Epub 2011 Aug 1.


Responsible Party:	Prof. Dr. med. Evangelos Giannitsis, Department of Cardiology, University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00953251 History of Changes
Other Study ID Numbers:	TnT hs 2
Study First Received:	August 5, 2009
Last Updated:	August 5, 2009
Health Authority:	Germany: Ethics Commission

Keywords provided by Heidelberg University:


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

Additional relevant MeSH terms:


Syndrome Acute Coronary Syndrome Disease Pathologic Processes	Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases

ClinicalTrials.gov processed this record on September 28, 2016