In the current study a normal reference value for cTn-I in blood from healthy adults will be determined and will be measured with the new device. This reference range is age-dependent. To measure the normal values per age group, blood samples will…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the 99th percentile URL of the Minicare cardiac troponin-I (cTn-I)
system in healthy male and female adults according to clinical laboratory
standards institute (CLSI) C28 A3 recommendations.
Secondary outcome
NA
Background summary
The Minicare cTn-I system is a new device that is developed for the diagnostics
of myocardial infarction. The device measures a protein called cardiac troponin
I (cTn I) in a blood sample. Troponins are proteins that are part of cardiac
cells and skeletal muscle cells. There are 3 types of troponins: troponin I,
troponin T, and troponin C. From these troponins, cardiac troponin-I (cTn-I) is
the only type that is unique for myocardia tissue. In general, cTn-I is present
at very low levels in the blood of healthy subjects. However, in patients with
myocardial infarction, heart muscle cells get damaged. As a result cTn-I may
enter the blood stream and values increase rapidly. Nowadays, measurement of
cTn-I levels in blood is accepted as the standard laboratory test for the
diagnosis of myocardial infarction.
Study objective
In the current study a normal reference value for cTn-I in blood from healthy
adults will be determined and will be measured with the new device. This
reference range is age-dependent. To measure the normal values per age group,
blood samples will be taken from 700 healthy adults (about 350 males and 350
females). The concentration of cTn-I in blood will be measured by using the
newly developed Minicare cTn-I system. The Minicare cTn-I system is a small
user-friendly portable apparatus to measure cTn-I levels in blood within
minutes. The measurement is based on nanotechnology (www.philips.com/minicare).
This study is not intended to improve your health, but is necessary to
determine the normal cTn-I values in blood of healthy volunteers. These values
are critical to be able to discriminate between healthy and elevated values of
cTn-I when using the Minicare cTn-I system.
Study design
For this study the volunteer will need to bring a valid proof of identity
(passport, driving license, residence permit or ID card). Upon arrival to the
research center the volunteer will undergo a short screening procedure during
which the volunteer will be asked to complete a questionnaire about his/her
health conditions. If the volunteer is considered eligible for this study based
on the questionnaire, 3 small blood samples will be taken and one finger prick
will be done. Two blood samples will be used to check if the blood is suitable
for the test. The other sample will be used for the test on the Minicare cTn-I
system. The volunteer can leave the research center after the blood draw. The
total length of the study will be less than 2 hours.
Study burden and risks
A venipuncture is a standard procedure to collect blood. The venipuncture and
finger prick may be painful and may also cause a light bleeding or a bruise. No
other adverse effects are to be expected.
High Tech Campus 29
Eindhoven 5656 AE
NL
High Tech Campus 29
Eindhoven 5656 AE
NL
Listed location countries
Age
Inclusion criteria
healthy male and female subjects
*18 years old
Exclusion criteria
1. Personal history of AMI or other cardiac diseases (MI, angina, stroke, atrial fibrillation, peripheral vascular disease (PVD), deep vein thrombosis (DVT), pulmonary embolism (PE), cardiac valve disease, heart failure), chronic obstructive pulmonary disease (COPD), immunological disease (eg. systemic lupus erythematosis [SLE] and reumatoid arthritis), diabetes mellitus, hypertension (except for subjects *70 years on stable medication for hypertension and normal/stabilized blood pressure) or drug-of-abuse (based on questionnaire)
2. History of cancer in last 5 years (evaluation through questionnaire).
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 | NL52805.056.15 |