TnThs for Identification Myocardial Infarction
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Purpose
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.
| Condition |
|---|
|
Acute Coronary Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- 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. [ Time Frame: 6 to 24 hours after admission ] [ Designated as safety issue: No ]
- Comparison of TnThs with cTnT, myoglobin and h-FABP. [ Time Frame: 6 to 24 hours after admission ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Blood samples (serum) were collected at presentation and after 6 hours. After collection, serum was centrifuged immediately and stored at -80°C until analysis.
The laboratory staff responsible for measurements was blinded to patient data.
| Enrollment: | 94 |
| Study Start Date: | May 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
patients with acute coronary syndrome
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. Unstable angina and non-ST-segment elevation myocardial infarction were diagnosed using the joint European Society of Cardiology/American College of Cardiology/American Heart Association/World Heart Federation Task Force redefinition of myocardial infarction guidelines. Patients with ST-segment elevation were excluded. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| Germany | |
| University of Heidelberg | |
| Heidelberg, Baden-Württemberg, Germany, 69120 | |
| Principal Investigator: | Evangelos Giannitsis, MD, FACC | University of Heidelberg |
More Information
No publications provided
| Responsible Party: | Prof. Dr. Evangelos Giannitsis, University of Heidelberg |
| ClinicalTrials.gov Identifier: | NCT00950469 History of Changes |
| Other Study ID Numbers: | TnThs 1 |
| Study First Received: | July 30, 2009 |
| Last Updated: | July 30, 2009 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by University of Heidelberg:
|
high sensitive troponin T; cardiac necrosis; early detection; myoglobin; h-FABP early identification and risk stratification of patients with suspicious acute coronary syndrome |
Additional relevant MeSH terms:
|
Myocardial Infarction Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Angina Pectoris Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013