Microvascular and Cardiovascular Status of Females with and without Migraine

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 100

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Endothelial function measured as changes in dermal blood flow after Local<br /><br>Thermal Hyperaemia using both the LDPI and LSCI expressed in arbitrary units.<br /><br>The parameters of these LTH measurements will be compared between women with<br /><br>and without migraine under three conditions (control condition, after<br /><br>pretreatment with EMLA and L-NMMA).<br /><br>- Endothelial function measured as Reactive Hyperaemia Index (RHI) using<br /><br>Peripheral Arterial Tonometry (EndoPAT) expressed in arbitrary units.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Determining the agreemement and reproducibility of two devices which measure<br />blood perfusion: the Laser Speckle Contrast Imager (LSCI) and the Laser Doppler<br />Perfusion Imager (LDPI).<br />- Blood: hormone levels, lipid profiles, vascular biomarkers, inflammatory<br />parameters and DNA.<br /><br />Other study parameters:<br />- Demographics<br />- Vascular risk factors (hypertension, intoxications, obesity, etc.)<br />- History of disease<br />- Medication use (painkillers, triptan, ergotamine, oral contraception, etc.)<br />- Migraine subtype, attack frequency</p>