To identify novel risk factors for TIA and stroke that can be measured in peripheral blood samples, in particular levels of proteins and other markers and genetic polymorphisms.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study is primarily aimed at the collection and storage of blood samples and
questionnaire data for future scientific research. The exact content of this
study is at this moment only partially specified. We aim to answer the
following research questions:
1) Are (genetic) factors that play a role in blood coagulation (hemostasis)
associated with the risk of TIA or stroke in this clinical cohort?
With more specific sub-questions:
-are levels of fibrinogen and fibrinogen-degradation products associated with
the risk of the outcome-measures under study?
- are variations in the fibrinogen-FGA en FGG genes associated with the risk of
the outcome-measures under study?
-are other genetic variations that play a role in hemostasis associated with
the risk of the outcome-measures under study?
2) Are new genetic risk factors for atherosclerosis associated with the risk of
TIA or stroke in this clinical cohort?
With more specific sub-questions:
-are variations in the alpha-adducin gene (ADD1) associated with the risk of
the outcome-measures under study?
-are genetic polymorphisms that play a role in metabolism of homocysteine (an
established risk factor for atherosclerosis and stroke) associated with the
risk of the outcome-measures under study?
-are other genetic variations that influence risk factors for atherosclerosis
associated with the risk of the outcome-measures under study?
3) Can results from a genome-wide association study, aimed at identifying new
risk genes for TIA or stroke, be replicated in this clinical cohort?
Secondary outcome
-
Background summary
Although several risk factors for transient ischemic attacks (TIAs) and stroke
have been identified, in a substantial proportion of TIAs and strokes the exact
cause remains unknown, even after ancillary investigations. Further studies are
required to identify additional risk factors , in order to improve prevention
and treatment of these neurovascualr events.
Furthermore, there is a need for predictive variables that can be measured in
an easy, inexpensive, and minimally invasive way, to enhance their usefulness
and applicability in daily clinical practice.
Peripheral bood samples are easily obtained through a minimally invasive
routine procedure, and can yield a large amount of information, including on
genetic factors.
In recent years, scientific interest has grown in the role of genetic factors
and gene-environment interactions in the pathogenesis of TIA and stroke.
Studying genetic polymorphisms and gene-environment interactions in relation to
occurrence of stroke or TIA may enhance insight in the pathogenetic mechanisms
that ultimately lead to vascular events.
Study objective
To identify novel risk factors for TIA and stroke that can be measured in
peripheral blood samples, in particular levels of proteins and other markers
and genetic polymorphisms.
Study design
Case-control design. Data (levels of serum markers and genetic polymorphisms)
will be collected of patients and control persons and compared through logistic
regression, with adjustment for potential confounders (obtained through a
questionnaire or from routine discharge letters). Multiplicative
interactionterms will be added to the statistical model to evaluate
gene-environment interactions.
Study burden and risks
The burden associated with participation in the study will consist of a single
venapunction, involving withdrawal of 20 ml of blood. Control persons will also
be asked to complete a short questionnaire. No risks are involved in
participation in this study.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Patients:
1) Acute stroke treated in the Stroke Unit of the department of Neurology
2) Transient ischemic attack (TIA) or minor ischemic stroke at the outpatient TIA service
3) Patient should be able to give informed consent
Control persons:
Spouses, partners, friends or neighbours of patients who are included in the current study, without a history of ischemic or hemorrhagic stroke or TIA.
Exclusion criteria
Relatives of patients do not qualify for control persons (because future research will include the study of genetic polymorphisms).
Persons who are not able to give informed consent will not be included in the study.
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 | NL16323.078.07 |