The primary objective is to determine and compare the microvascular status between middle-aged women with and without migraine. Secondary objectives include a determination of the agreement and reproducibility of two devices which measure the blood…
ID
Source
Brief title
Condition
- Headaches
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Endothelial function measured as changes in dermal blood flow after Local
Thermal Hyperaemia using both the LDPI and LSCI expressed in arbitrary units.
The parameters of these LTH measurements will be compared between women with
and without migraine under three conditions (control condition, after
pretreatment with EMLA and L-NMMA).
- Endothelial function measured as Reactive Hyperaemia Index (RHI) using
Peripheral Arterial Tonometry (EndoPAT) expressed in arbitrary units.
Secondary outcome
- Determining the agreemement and reproducibility of two devices which measure
blood perfusion: the Laser Speckle Contrast Imager (LSCI) and the Laser Doppler
Perfusion Imager (LDPI).
- Blood: hormone levels, lipid profiles, vascular biomarkers, inflammatory
parameters and DNA.
Other study parameters:
- Demographics
- Vascular risk factors (hypertension, intoxications, obesity, etc.)
- History of disease
- Medication use (painkillers, triptan, ergotamine, oral contraception, etc.)
- Migraine subtype, attack frequency
Background summary
Migraine is an important and underestimated female-specific cardiovascular risk
factor, which occurs three times more often in women compared to men. The
association between migraine and cardiovascular disease has been demonstrated
in several large epidemiological studies, although the underlying
pathophysiological mechanisms remains poorly understood. However, 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. To date, we have performed non-invasive measurements of the
microvasculature in middle-aged women with and without migraine and a history
of stroke and polycystic ovary syndrome (PCOS) in order to understand how these
diseases interact with migraine to have a synergistic effect on cardiovascular
outcome. However, the question remains to what extent these results are
generalizable to relatively healthy middle-aged women. Therefore, to gain
further insight into the microvascular function of healthy middle-aged women
with and without migraine, we will validate our methods by performing
non-invasive measurements of the microvasculature in healthy middle-aged (40-60
years) women with and without migraine.
Study objective
The primary objective is to determine and compare the microvascular status
between middle-aged women with and without migraine. Secondary objectives
include a determination of the agreement and reproducibility of two devices
which measure the blood perfusion: the Laser Speckle Contrast Imager (LSCI) and
the Laser Doppler Perfusion Imager (LDPI).
Study design
This is a cross-sectional observational study with non-invasive measurements.
Also, repeated measurements will take place one month later for half of the
participants.
Study burden and risks
Risks of LTH and LDPI/LSCI: none documented. Risks of EndoPAT: none documented.
Risks of venipuncture: mild pain and bruising.
The burden for participants will consist of approximately 3 hours per visit.
Half of the participants will be asked to repeat the measurements one month
later.
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 health related benefits for the participants, but
participants will be offered a financial compensation.
Wytemaweg 80
Rotterdam 3015 CE
NL
Wytemaweg 80
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Women aged 40-60 years without a history of ischemic stroke, preeclampsia and
PCOS (i.e. control group, free of comorbidities which have been investigated in
our previous multicenter CREW-MIST consortium);
- If the participants are still fertile, they should fulfill at least one of
the following criteria:
o a regular menstrual cycle of 25-30 days as measurements will be performed in
the middle of their cycle;
o use of oral combination pill and inclusion should not take place in the
withdrawal week;
o use of Mirena, Kyleena, Liletta, and Skyla (hormonal intrauterine devices)
or Nexplanon/Implanon (etonogestrel birth control implant).
- Capable and willing to provide informed consent.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- A medical history or self-reported symptoms of conditions related to
(peripheral) vascular disease, e.g. cardio- or cerebrovascular events,
peripheral arterial disease, chronic kidney disease, (pre)diabetes mellitus,
uncontrolled chronic hypertension, congestive heart failure, hyperlipidemia,
hypercholesterolemia, et cetera;
- Current use of any drugs as primary or secondary prevention of cardiovascular
disease;
- Current or former non-incidental smoking (all substances);
- Alcohol consumption of more than seven alcohol units per week;
- Current or prior substance dependence/addiction (alcohol, illicit drugs,
tranquillizers, narcotics, analgesics);
- Current pregnancy;
- Insufficient mastery of Dutch or English;
- Any other (serious) illnesses that can compromise study participation;
- Skin conditions (e.g. psoriasis, eczema, rosacea), scars or tattoos on
ventral side of lower arm or digits;
- (Any known) allergy for EMLA or L-NMMA;
- Any COVID-19 related symptoms (we will perform a screening by phone) on the
day of the measurements.
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 | NL75720.078.20 |