Skip to content

TnThs for Identification Myocardial Infarction

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00950469
Enrollment
94
Registered
2009-07-31
Start date
2008-05-31
Completion date
2008-12-31
Last updated
2009-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Sponsors

Prof. Dr. Evangelos Giannitsis
CollaboratorUNKNOWN
Heidelberg University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
Comparison of TnThs with cTnT, myoglobin and h-FABP.6 to 24 hours after admission

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026