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

NCT ID: NCT01374607

Last Updated: 2016-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-12-31

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.

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.

Conditions

Acute Coronary Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

John O. Prior

Chief Nuclear medicine Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olivier Muller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

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. doi: 10.1056/NEJMoa0900428.

Reference Type: BACKGROUND

PMID: 19710484 (View on PubMed)

Morawiec B, Fournier S, Tapponnier M, Prior JO, Monney P, Dunet V, Lauriers N, Recordon F, Trana C, Iglesias JF, Kawecki D, Boulat O, Bardy D, Lamsidri S, Eeckhout E, Hugli O, Muller O. Performance of highly sensitive cardiac troponin T assay to detect ischaemia at PET-CT in low-risk patients with acute coronary syndrome: a prospective observational study. BMJ Open. 2017 Jul 10;7(7):e014655. doi: 10.1136/bmjopen-2016-014655.

Reference Type: DERIVED

PMID: 28698323 (View on PubMed)

Other Identifiers

18/11

Identifier Type: -

Identifier Source: org_study_id