Clinical trial NCT00950469: TnThs for Identification Myocardial Infarction
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: high sensitive troponin T; cardiac necrosis; early detection; myoglobin; h-FABP
early identification and risk stratification of patients with suspicious acute coronary syndrome
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Prof. Dr. Evangelos Giannitsis
First posted: 2009-07-31
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 94 consecutive patients without ST-segment elevation admitted to the Chest Pain Unit of the University of Heidelberg were enrolled with symptoms suggestive of ACS.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 to 24 hours after admission
Secondary outcomes:
measure: Comparison of TnThs with cTnT, myoglobin and h-FABP.
timeFrame: 6 to 24 hours after admission
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: Heidelberg University
name: Evangelos Giannitsis, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References: