To gain further insight into the interaction and possibly shared pathophysiological mechanisms of female-specific cardiovascular risk factors and events we will quantify white matter hyperintensities on brain MRI and assess endothelial function in…
ID
Source
Brief title
Condition
- Headaches
- Reproductive tract disorders NEC
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* White matter hyperintensities (WMH) load on brain Magnetic Resonance Imaging
(MRI) graded in volume.
* Endothelial function measured as dermal blood flow changes (DBF) after Local
Thermal Hyperaemia (LTH) using Laser Doppler Perfusion imaging (LDPI) expressed
in arbitrary units.
* Endothelial function measured as Reactive Hyperaemia Index (RHI) using
Peripheral Arterial Tonometry (EndoPAT) expressed in arbitrary units.
Secondary outcome
* Location of white matter hyperintensities
* Location of stroke
* Stroke subtype (large artery, cardioembolism, small vessel occlusion, other
determined, undetermined)
* Comparison of LTH measurements after pre-treatment with EMLA or LNMMA
* Serum markers for endothelial dysfunction and gonadal hormone levels
Background summary
Current cardiovascular risk prediction models are likely to underestimate risk
when applied to young women. Probably, this is due to the failure to
acknowledge risk factors exclusive to women, such as pregnancy-related changes
and a different impact of risk factors that are not gender-specific, such as
smoking and obesity. An important example of female-specific cardiovascular
features is migraine, which occurs three times more often in women compared to
men and is associated with a twofold increased risk of ischemic stroke. The
association between migraine and cardiovascular disease has been demonstrated
in several large studies. A growing number of studies also show associations
between migraine and increased risk for pregnancy-related vascular events such
as gestational hypertension and preeclampsia (PE). It remains unclear to what
extent female-specific risk factors, including polycystic ovary syndrome
(PCOS), primary ovarian insufficiency (POI) and PE, interact with migraine to
have a synergistic effect on cardiovascular disease (CVD) outcome. It is
suggested that signs and symptoms of cardiovascular disease in women are
related to microvascular ischemia and endothelial dysfunction, more so than in
men. In both women with preeclampsia and women with migraine a higher risk for
the presence of white matter hyperintensities on brain MRI have been found as a
possible indication of vascular damage.
Study objective
To gain further insight into the interaction and possibly shared
pathophysiological mechanisms of female-specific cardiovascular risk factors
and events we will quantify white matter hyperintensities on brain MRI and
assess endothelial function in selected groups of young women with and without
migraine and a history of stroke or reproductive disorder.
Study design
Observational multicentre case-control study.
Study burden and risks
Risks of MRI: none documented. Risks of LTH and LDPI: none documented. Risks of
EndoPAT: none documented. Risks of venipuncture: mild pain and bruising
The burden for participants will consist of a visit of 30 minutes for the MRI
brain or 130 minutes for the MRI of the brain combined with endothelial
function measurements. It is possible that mild discomfort will be experienced
during inflation of blood pressure cuff lasting for five minutes. Furthermore a
venipuncture will be performed for blood withdrawal which may lead to pain
and/or bruising.
Participation does not hold benefits for the participants. In the case of high
quantity of white matter hyperintensities or severe endothelial dysfunction the
general practitioner will be requested to screen for possible cardiovascular
risk factors. However it is uncertain if this is a potential benefit for the
participant.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
Age between 40 and 60 years
Female
Capable and willing to provide informed consent
Stroke cohorts: stroke diagnosed by cerebral imaging and verified in clinical
records
Preeclampsia cohorts: fulfil criteria for diagnosis PE, verified in clinical
records
PCOS cohorts: fulfil Rotterdam criteria for diagnosis PCOS
Exclusion criteria
Insufficient mastery of Dutch
Any serious illness that can compromise study participation
Current pregnancy
Stroke cohorts: TIA, retinal infarction or venous infarction
Contra-indications for MRI
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL54324.058.15 |