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Comparison Between High-sensitivity Cardiac Troponin T and Standard Tnl Assays in Early Cardiac Ischemia Detection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Lausanne Hospitals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01374607
First received: June 8, 2011
Last updated: October 18, 2011
Last verified: April 2011
History of Changes
  Purpose

It is crucial to rapidly identify cardiac ischemia in the care of patients with suspected acute coronary syndrome (ACS). Cardiac troponins are a major factor in the diagnostic of myocardial infarction. New methods have been developed to improve the accuracy of the assay and determine low troponin concentrations. Elecsys® (highly sensible T troponin) TnT-HS assay is supposed to help early detection of myocardial infarction after onset of symptoms. It should therefore shorten the transit time to emergencies by a more rapid intervention or a faster return home. The aim of the study is to compare TnT-HS assay to the standard troponin assay in the detection of early cardiac ischemia in patients with ACS.


Condition
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Highly Sensible T Troponin (Hs-TnT) Assay Compared to Standard Troponin Assay in the Early Detection of Cardiac Ischemia in Patients With Acute Coronary Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • patients presenting to the emergency for chest pain suspect for ACS currently have 2 troponin assays (Tn I) performed at T0 and T6. The additional value of a high sensitivity cardiac troponin T (Hs-TnT) dosage performed at T0 will be analyzed. [ Time Frame: T0 (admission) ] [ Designated as safety issue: No ]
  • patients presenting to the emergency for chest pain suspect for ACS currently have 2 troponin assays (Tn I) performed at T0 and T6. The additional value of a high sensitivity cardiac troponin T (Hs-TnT) dosage performed at T2 will be analyzed. [ Time Frame: T2 (2 hours after admission) ] [ Designated as safety issue: No ]
  • patients presenting to the emergency for chest pain suspect for ACS currently have 2 troponin assays (Tn I) performed at T0 and T6. The additional value of a high sensitivity cardiac troponin T (Hs-TnT) dosage performed at T6 will be analyzed. [ Time Frame: T6 (6 hours after admission) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • major cardiovascular events [ Time Frame: at 30 days of admission ] [ Designated as safety issue: No ]

Estimated Enrollment: 781
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Patients with suspected ACS with 2/2 negative results of conventional troponin I assay and 1/3 positive result of highly sensitive troponin assay will have a non invasive cardiac Rb82 PET/CT performed within 24 hours of admission. This exam is recognized by Associations of cardiology for its high sensibility and specificity in coronary disease detection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting to the emergency with chest pain suspect of acute coronary syndrome

Criteria

Inclusion Criteria:

  • chest pain of ≥ 5 minutes during the last 24 hours, or other symptoms suggestive of ACS (unstable angina or NSTEMI) with 2 negative standard troponin values(<0.09 µg/L)
  • age ≥ 18

Exclusion Criteria:

  • patients with ST- segment elevation myocardial infarction (STEMI)
  • detection of TnI standard values > 0.09 (limit of positivity) in one of two blood samples (T0 and T6)
  • detection of heart disease or extra-cardiac disease that could explain the elevated conventional troponin values ​​
  • presence of major organ dysfunction, infection or major underlying medical condition that could compromise the patient's ability to perform a stress test for myocardial ischemia
  • cancer with prognosis < 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01374607

Contacts
Contact: Olivier Muller, MD, PhD +41 21 314 00 03 olivier.muller@chuv.ch
Contact: Nathalie Lauriers, Study nurse +41 79 55 60 618 nathalie.lauriers@chuv.ch

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Vaud, Switzerland, 1011
Sub-Investigator: Eric Eeckhout, MD            
Sub-Investigator: Olivier Hugli, MD            
Sub-Investigator: John O Prior, PhD MD            
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Olivier Muller, MD, PhD Centre Hospitalier Universitaire Vaudois
  More Information

Publications:

Responsible Party: O. Muller, MD PhD, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01374607     History of Changes
Other Study ID Numbers: 18/11
Study First Received: June 8, 2011
Last Updated: October 18, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Lausanne Hospitals:
acute coronary syndrome
myocardial ischemia
high-sensitivity cardiac troponin T

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Ischemia
Acute Coronary Syndrome
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013