NCT01374607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

1.9 years

First QC Date

June 8, 2011

Last Update Submit

January 24, 2016

Conditions

Acute Coronary Syndrome

Keywords

acute coronary syndromemyocardial ischemiahigh-sensitivity cardiac troponin T

Outcome Measures

Primary Outcomes (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 T0 will be analyzed.

    T0 (admission)

  • 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.

    T2 (2 hours after admission)

  • 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.

    T6 (6 hours after admission)

Secondary Outcomes (1)

  • major cardiovascular events

    at 30 days of admission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 19710484BACKGROUND

  • 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.

    PMID: 28698323DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Olivier Muller, MD, PhD

    Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Nuclear medicine Department

Study Record Dates

First Submitted

June 8, 2011

First Posted

June 16, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

January 26, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)