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
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:
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 April 15, 2014