TnThs Predicting Evolving Non-STEMI
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ClinicalTrials.gov Identifier: NCT00953251 |
Recruitment Status
:
Completed
First Posted
: August 6, 2009
Last Update Posted
: August 6, 2009
|
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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 or disease |
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Acute Coronary Syndrome |
Study Type : | Observational |
Actual Enrollment : | 115 participants |
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 |
Study Start Date : | May 2008 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |
Group/Cohort |
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patients with acute coronary syndrome
patients with acute coronary syndrome
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Non-STEMI and unstable angina |
- 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 ]
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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953251
Germany | |
University of Heidelberg | |
Heidelberg, Baden-Württemberg, Germany, 69120 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
First Posted: | August 6, 2009 Key Record Dates |
Last Update Posted: | August 6, 2009 |
Last Verified: | August 2009 |
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 |