TnThs for Identification Myocardial Infarction

Acute Coronary Syndrome Clinical Trial

Official title:

Comparison of the New High Sensitive Cardiac Troponin T With the 4th Generation Troponin-T, Myoglobin, Heart-type Fatty Acid Binding Protein for Early Identification of Myocardial Necrosis in Patients With Suspected Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950469
• Other study ID #: TnThs 1
• Status: Completed
• Phase: N/A
• First received: July 30, 2009
• Last updated: July 30, 2009
• Start date: May 2008
• Est. completion date: December 2008

Study information

• Verified date: July 2009
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

OBJECTIVES/BACKGROUND: We sought to determine the early diagnostic value of the new high sensitive cardiac troponin T assay (TnThs) in suspected acute coronary syndrome (ACS) and to compare it with the 4th generation cTnT assay from the same manufacturer, myoglobin and heart-type fatty acid binding protein (h-FABP).

METHODS: The study consisted of 94 patients with chest pain admitted to the chest pain unit with the diagnosis of suspected ACS without ST-Elevation. Patients were divided according to time from onset of symptoms to presentation into an early presenter group (<4 hours) and a late presenter group (≥4 hours).

A median of 6 samples (range 2-8) were available per patient. The diagnostic performance of TnThs was assessed using ROC analysis and areas under the curve (AUC) of baseline and follow-up results of TnThs, cTnT, myoglobin, and h-FABP were compared using c-statistics.

RESULTS: The TnThs assay allows an excellent prediction of non-ST-segment-elevation myocardial infarction (non-STEMI) at presentation.A follow-up sample improves diagnostic performance in a time dependent manner. The AUC of the TnThs was superior to cTnT at all time points.

CONCLUSIONS: A baseline sample of TnThs allows an earlier prediction of non-STEMI than the less sensitive and precise 4th generation cTnT assay. The excellent performance of TnThs at baseline and follow-up might obviate the need for other early necrosis markers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• consecutive patients with ACS

Exclusion Criteria:

• Patients with ST-segment elevation at presentation were excluded as were patients with muscular trauma, or severe kidney dysfunction defined as an estimated glomerular filtration rate below 60 ml/min/1.73m2.

• In addition patients who underwent percutaneous coronary intervention during follow-up sampling were also excluded

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Locations

Country	Name	City	State
Germany	University of Heidelberg	Heidelberg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Prof. Dr. Evangelos Giannitsis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the early diagnostic value of the new high sensitive cardiac troponin T assay (TnThs) for earlier detection of myocardial necrosis in suspected acute coronary syndrome.		6 to 24 hours after admission	No
Secondary	Comparison of TnThs with cTnT, myoglobin and h-FABP.		6 to 24 hours after admission	No