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

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ClinicalTrials.gov Identifier: NCT01374607
Recruitment Status : Completed
First Posted : June 16, 2011
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
John O. Prior, University of Lausanne Hospitals

Brief Summary:
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 or disease
Acute Coronary Syndrome

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.

Study Type : Observational
Actual Enrollment : 80 participants
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
Study Start Date : July 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

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Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]

Secondary Outcome Measures :
  1. major cardiovascular events [ Time Frame: at 30 days of admission ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374607


Locations
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Olivier Muller, MD, PhD Centre Hospitalier Universitaire Vaudois

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John O. Prior, Chief Nuclear medicine Department, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01374607     History of Changes
Other Study ID Numbers: 18/11
First Posted: June 16, 2011    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John O. Prior, University of Lausanne Hospitals:
acute coronary syndrome
myocardial ischemia
high-sensitivity cardiac troponin T

Additional relevant MeSH terms:
Syndrome
Ischemia
Acute Coronary Syndrome
Coronary Artery Disease
Myocardial Ischemia
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases