TnThs for Identification Myocardial Infarction

This study has been completed.
Sponsor:
Collaborator:
Prof. Dr. Evangelos Giannitsis
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00950469
First received: July 30, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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.

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00950469

Locations
Germany
University of Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Prof. Dr. Evangelos Giannitsis
Investigators
Principal Investigator: Evangelos Giannitsis, MD, FACC Heidelberg University
  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 Heidelberg University:
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:
Acute Coronary Syndrome
Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014