NL-OMON51120尚未招募不适用
Microvascular and Cardiovascular Status of Females with and without Migraine - VASCULAR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •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.
排除标准
- •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
- •- 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.
研究者
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