TnThs Predicting Evolving Non-STEMI

NCT00953251 | Completed

• 1 other identifier: TnT hs 2
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

patients with acute coronary syndrome

patients with acute coronary syndrome

Non-STEMI and unstable angina

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (1)

• 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.

  PMID: 21807867 DERIVED

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.

MeSH Terms

Conditions

Acute Coronary Syndrome; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 6, 2009
• Study Start: May 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 6, 2009

Record last verified: 2009-08

Locations

DE (1)