TnThs Predicting Evolving Non-STEMI

This study has been completed.

Sponsor:

Information provided by:

University of Heidelberg

ClinicalTrials.gov Identifier:

NCT00953251

First received: August 5, 2009

Last updated: NA

Last verified: August 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	August 5, 2009
Last Updated Date	August 5, 2009
Start Date ^ICMJE	May 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 5, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	TnThs Predicting Evolving Non-STEMI
Official Title ^ICMJE	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
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 Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: 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.
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.
Condition ^ICMJE	Acute Coronary Syndrome
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	patients with acute coronary syndrome patients with acute coronary syndrome Non-STEMI and unstable angina
Publications *	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. Epub 2011 Aug 1.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	115
Completion Date	December 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT00953251
Other Study ID Numbers ^ICMJE	TnT hs 2
Has Data Monitoring Committee	No
Responsible Party	Prof. Dr. med. Evangelos Giannitsis, Department of Cardiology, University of Heidelberg
Study Sponsor ^ICMJE	University of Heidelberg
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Heidelberg
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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