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
Information provided by:
University of Lausanne Hospitals
First received: June 8, 2011
Last updated: October 18, 2011
Last verified: April 2011
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.
||Observational Model: Cohort
Time Perspective: Prospective
||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
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2012 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients presenting to the emergency with chest pain suspect of acute coronary syndrome
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01374607
|Centre Hospitalier Universitaire Vaudois
|Lausanne, Vaud, Switzerland, 1011 |
|Sub-Investigator: Eric Eeckhout, MD |
|Sub-Investigator: Olivier Hugli, MD |
|Sub-Investigator: John O Prior, PhD MD |
University of Lausanne Hospitals
||Olivier Muller, MD, PhD
||Centre Hospitalier Universitaire Vaudois
Reichlin T, Hochholzer W, Bassetti S, Steuer S, Stelzig C, Hartwiger S, Biedert S, Schaub N, Buerge C, Potocki M, Noveanu M, Breidthardt T, Twerenbold R, Winkler K, Bingisser R, Mueller C. Early diagnosis of myocardial infarction with sensitive cardiac troponin assays. N Engl J Med. 2009 Aug 27;361(9):858-67.
||O. Muller, MD PhD, University of Lausanne Hospitals
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 8, 2011
||October 18, 2011
Keywords provided by University of Lausanne Hospitals:
acute coronary syndrome
high-sensitivity cardiac troponin T
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014
Acute Coronary Syndrome
Coronary Artery Disease
Signs and Symptoms
Arterial Occlusive Diseases