The primary objective is to compare the analytical performance (method and sample comparison) of Minicare high sensitive troponin I testing (POC, different sample types) and conventional venipuncture troponin I test in our central hospital…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Minicare POC (different sample types) vs conventional HS cTnI CL test (Method
comparison)
* Minicare capillary vs. Minicare venipuncture and vs. Minicare plasma (Sample
comparison)
The analyses linked to the primary objectives are:
* The agreement between POC (three sample types) and CL testing by using the
Bland-Altman method.
* The relationship between POC (three sample types) and CL by linear regression
and Pearson*s correlation.
* The agreement between different POC sample types by using the Bland-Altman
method.
* The relationship between POC sample types by linear regression and Pearson*s
correlation.
Secondary outcome
* To create an overview of baseline characteristics of the population.
* The mortality and major adverse cardiovascular events (MACE) of the
population at 30 days. MACE is defined as a composite of cardiac death and
myocardial infarction.
* To compare final patients diagnosis (ACS vs. no ACS) and treatment based on
POC venous troponin testing versus CL plasma troponin I testing versus HS cTnT
plasma testing (regular patient care).
* To create an overview of the sensitivity, specificity, negative predictive
value (NPV) and positive predictive value (PPV) of POC and standard laboratory
troponin I testing.
* To determine amount of false positive and false negative results for the POC
and if there is a significant difference compared to CL testing.
Background summary
Point-of-care (POC) troponin testing, defined as laboratory testing near a
patient location with rapid availability of results, has attracted much
interest in the emergency department setting (ED) and seems feasible. These
devices might enable earlier decisions, reduce stay at the ED and improve
patient flow. While an elevated troponin in patients with suspected acute
coronary syndrome (ACS) confirms diagnosis and initiates adequate treatment,
ruling out ACS aids in proper patient dismissal.
A next step could be ruling out myocardial infarction by the general
practitioner (GP) or fast responder using an on-site POC troponin test.
However, drawing venous blood might not be easily available to every GP,
especially not during peak hours.
The Minicare cTnI is a bedside system which requires capillary blood, venous
whole blood or plasma. The results of the troponin will be given within 10
minutes. It is a very sensitive troponin test, the most clinically sensitive
available POC for c-Troponi.
Currently Minicare prepares for a high sensitive troponin analysis targeting a
reliable result within an hour after onset of chest pain. The objective of this
study is to determine if high sensitive troponin testing by Minicare has the
same analytical performance as standard high sensitivity troponin I testing in
our central hospital laboratory (ARCHITECT immunoassay analyzer, Abbott).
Study objective
The primary objective is to compare the analytical performance (method and
sample comparison) of Minicare high sensitive troponin I testing (POC,
different sample types) and conventional venipuncture troponin I test in our
central hospital laboratory (CL) with the Abbott Architect.
Study design
This study is a prospective, observational, cohort study aiming to compare
point-of-care high-senstive troponin I testing from different sample types with
CL HS cTnI plasma samples.
All patients aged 18 years or older referred to the cardiac ED with chest pain
suspected of ACS and having standard troponin tests ordered by their treating
ED physician are eligible for the study. Written informed consent will be
obtained from each study participant. STEMI patients who already underwent
rescue PCI are eligible for the study as well.
Patients will receive standard medical care defined by their treating physician
and based upon complaints, physical examination and laboratory results
including standard HS cTnT analyses.
From every included patient capilary blood samples and an extra venous blood
sample will be drawn to evaluate HS cTnI levels obtained with the POC
instrument and CL. All samples will be collected twice, upon arrival in the ED
(T=0) and one hour after arrival (T=1). This is in concordance with our regular
HS cTnT protocol. In STEMI patients however the sample will only be drawn once.
The study will be conducted in a medium sized hospital with 24/7 PCI
availability in the Netherlands. This cardiac ED has approximately 5500
presentations a year.
A registry of all included patients and their troponin results (POC, CL and HS
cTnT) will be made to compare these testing methods. One study sample set per
patient will be used for the method and sample comparison. The second study
sample set will be used for evaluating the secondary objectives.
Study nurses and clinical chemistry analists will be trained on the study
workflow including usage of the POC analyzer and adequate fingerstick technique
with deep puncture of a suitable fingertip.
Study burden and risks
We expect no adverse events and there are no expected risks associated with
this protocol. The burden on the patient is low. The fingerstick is a
non-invasive procedure and for the collection of venous blood we use the
regular troponin protocol at our hospital. The patients do not undergo an extra
venipuncture.
We monitor patients for one month after their visit / admission by their
medical file. There will be no additional visits.
Tegelseweg 210
Venlo 5912 BL
NL
Tegelseweg 210
Venlo 5912 BL
NL
Listed location countries
Age
Inclusion criteria
* Patients 18 years or older with chest pain suspected of ACS.
* STEMI patient who already underwent rescue PCI; inclusion post PCI.
Exclusion criteria
* Out of hospital cardiac arrest.
* Patients with sudden onset tachycardia and a frequence 110 bpm or higher,
(supraventricular or ventricular).
* Patients who are hemodynamically unstable or in which an acute non-coronary
diagnosis is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc.
* Patients already admitted for the same set of symptoms at a previous
healthcare institution before being transferred to the participating clinical
site.
* Patients not willing or not able to provide informed consent due to their
medical condition as judged by the physician
Design
Recruitment
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 | NL70186.096.19 |