Primary objective: To define the optimal cut-off concentrations for the POC hs-cTnI assay to rule out or rule in MI.Secondary objective: To determine and validate an assay-specific 0/1-h algorithm for ruling out and ruling in MI.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. NSTE-ACS at discharge
2. Myocardial infarction at discharge
3. Safety endpoint: negative predictive value and sensitivity (POC hs-cTnI,
standard of care hs-cTn)
4. Accuracy endpoint: positive predictive value and specificity
Secondary outcome
5. Composite of all-cause mortality, MI and urgent revascularisation at 30 days
6. Length of stay (in hours)
7. Turnaround time POC and standard of care hsTroponin from blooddraw until
result
Background summary
Patients presenting with acute chest pain should be referred to the hospital
promptly. In the absence of clear ST-segment elevations, evaluation with
cardiac troponin (cTn) is necessary to rule out any myocardial injury. The
introduction of high-sensitive cTn made it possible to reliably measure small
amounts cTn concentrations, thereby increasing sensitivity and reducing
time-to-diagnosis. Novel POC hs-cTn assays give the opportunity to use
fingerstick sampling and a reduced analysis time of 8 minutes. To date, no
cut-off concentration for rule-out of MI has been established for the POC
hs-cTnI assay on the VTLi analyser (Siemens). We hypothesize that patients with
chest pain can be diagnosed as accurate as standard of care (hs-cTnT and
hs-cTnI) by using the VTLi POC assay. This study aims to define optimal cut-off
concentrations for POC hs-cTnI at presentation to identify patients at low risk
and also at high risk of MI.
Study objective
Primary objective: To define the optimal cut-off concentrations for the POC
hs-cTnI assay to rule out or rule in MI.
Secondary objective: To determine and validate an assay-specific 0/1-h
algorithm for ruling out and ruling in MI.
Study design
Single-centre, prospective observational study.
All patients with suspected NSTE-ACS will undergo hs-cTn testing (T0, standard
of care). Simultaneously, an additional capillary blood sample (fingerstick)
will be drawn for POC hs-cTnI testing.
A second hs-cTn test may be performed as part of routine care (T1). This second
test is intended to analyze whether there is a significant rise or fall in
troponin to either rule-in or rule-out MI. The decision to perform the second
cTn test is left at the discretion of the treating physician. Again, an
additional capillary blood sample (fingerstick) will be drawn for POC hs-cTnI
testing next to the second blood draw.
Patients will be monitored until discharge. There will be no post-discharge
follow-up. Additional data relevant for this study will be extracted from the
patient record database. Other demographic and clinical parameters at baseline
will be taken into account.
Study burden and risks
In all patients, a fingerstick (POC hs-cTn) blood sample will be drawn at
presentation at the emergency department (T0). If needed, after one hour (T1) a
second fingerstick (POC hs-cTn) will be drawn. Besides the minimal risks of
performing a POC finger prick test, no other risks are involved with study
participation.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- Symptoms suggestive of MI and troponin measurement for ruling out/in ACS is
indicated
Exclusion criteria
- Age < 18 years
- Pregnancy
- No 12-lead ECG performed or available
- Electrocardiographic ST-segment elevation
- Missing measurements of the POC hs-cTnI or standard of care hs-cTn
- Patients transferred from an outside hospital (e.g. for PCI treatment)
- An obvious non-cardiac cause for the chest complaints (trauma, pneumothorax,
pneumonia, etc.)
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 | NL84129.100.23 |