TnThs Predicting Evolving Non-STEMI

• Sponsor: Heidelberg University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00953251
• Collaborator: (none)
• Enrollment: 115
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 16.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome

Study Design

• 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 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
patients with acute coronary syndrome patients with acute coronary syndrome
Non-STEMI and unstable angina

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Heidelberg	Heidelberg	Baden-Württemberg	Germany	69120

Sponsors and Collaborators

• Heidelberg University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00953251
• Other Study ID Numbers: TnT hs 2
• First Posted: Aug 6, 2009
• Last Update Posted: Aug 6, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: 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: Acute Coronary Syndrome; Syndrome

Study Results

No Results Posted as of Aug 6, 2009