To determine the clinical performance of Elecsys® Troponin Ths Gen 6 relative to the clinical diagnosis at different time points after patient admission (T0, T1, T2, T3, T6) using the previously determined universal or combined sex-specific cut-off…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
primary endpoint: Negative predictive value (NPV) of troponin Ths measured by
the 6th generation test at T3
Secondary outcome
clinical performance of troponin Ths gene 6 at other time points after admission
Performance of the troponin Ths gene 6 assay when the assay is used in the
rapid rule-out algorithm as described by the European Society of Cardiology
(ESC)
Background summary
The Elecsys® Troponin T hs generation 6 assay is an immunoassay utilizing the
electrochemiluminescence »ECLIA« technology for the quantitative, highly
sensitive in vitro measurement of human cardiac troponin T (hcTnT) in human
serum and plasma. The test uses two monoclonal antibodies specifically directed
against hcTnT. The Elecsys® Troponin T hs Gen 6 assay has improved analytical
sensitivity compared to the previous assay generation, detecting both free
troponin T and binary and ternary complexes of troponin.
This study is being conducted to obtain approval for use of Elecsys® Troponin
Ths Gen 6 in clinical practice by the regulatory authorities, including the US
FDA, for CE Marking (EU), by the NMPA (China) and by the PMDA (Japan).
Study objective
To determine the clinical performance of Elecsys® Troponin Ths Gen 6 relative
to the clinical diagnosis at different time points after patient admission (T0,
T1, T2, T3, T6) using the previously determined universal or combined
sex-specific cut-off value (the 99th percentile URL of a healthy reference
population).
Study design
Prospective, non-interventional, single-arm, longitudinal cohort multicenter
study enrolling patients with signs and symptoms of ACS
Study burden and risks
The burden is a maximum of 4 extra venipuntures during admission, a maximum of
5 x blood sampling (19 mL) and 2 x follow-up by telephone. The only risks of
the study are the possible side effects of a venipuntures.
Sandhofer Strasse 116
Mannheim 63805
DE
Sandhofer Strasse 116
Mannheim 63805
DE
Listed location countries
Age
Inclusion criteria
Signed Informed Consent
Age >=20 Years
Subjects demonstrating symptoms suggestive of acute coronary syndrome and/or
myocardial ischemia, such as any of the following:
Chest pain, pressure, or a burning sensation across the precordium and
epigastrium
Pain that radiates to neck, shoulder, jaw, back, upper abdomen, or either arm
Acute onset or worsening dyspnea
Nausea, vomiting, or indigestion
Lightheadedness or syncope
Diaphoresis
Generalized weakness or fatigue
Troponin or other cardiac marker determination planned as part of suspected ACS
routine care
Asymptomatic subjects with atypical symptoms in whom myocardial infarction is
being suspected
Exclusion criteria
none
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82227.000.22 |