Vascular Function and Uterine Fibroids
Condition: Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Observational

Summary: 
      The purpose of this study is to learn how uterine fibroids may be connected to heart disease
      and high blood pressure. It is not known what causes fibroids, but they frequently occur in
      women who also have high blood pressure, heart disease, and stroke. The investigators of this
      study want to learn if certain changes in the blood vessels or nerve activity can put women
      at risk for these diseases and for fibroids.
    

Detailed description: 
      The investigators are inviting women, 25-50 years old, who have not gone through menopause to
      participate in this study. The investigators are looking for some women with uterine fibroids
      and some without uterine fibroids based on ultrasound or MRI. If the patients have not had a
      recent ultrasound or MRI of the uterus, a physician can provide one.

      Individuals cannot participate if they have high blood pressure, diabetes, or disease in the
      kidneys, lungs, or blood vessels. Also, individuals who smoke, have high cholesterol, or are
      obese (BMI is higher than 30) cannot participate. Certain medications, including high blood
      pressure medications, beta-blockers and anti-depressants, will also limit potential patient
      participation. The investigators would be happy to review medications for potential
      participants.

      Screen Day:

      One of the members of the research team will review the study and the informed consent
      document with the patient. The patient will have their height, weight, blood pressure, pulse
      and respirations measured. The patient will also complete three questionnaires. If the
      patient has not had an ultrasound of the uterus in the last 12 months, a physician will
      complete one for her.

      Study Day:

      The patient will need to fast overnight (no eating or drinking). The investigators will draw
      a blood sample and then do a series of tests on the participant's blood vessels. For some of
      the tests, medication will be given through an IV. The investigators will also test nerve
      activity in the nerve on the outer aspect of the leg.
    

Intervention name(s): Brachial artery catheter; Acetylcholine; Nitroprusside; Norepinephrine; Nitroprusside and phenylephrine
Intervention type(s): Device; Drug; Drug; Drug; Drug
Intervention description(s): A catheter will be placed in the brachial artery by a physician on the study day.; Acetylcholine will be infused into the brachial catheter while blood flow levels in the forearm are measured. Acetylcholine will be infused at the following doses: 1.0, 2.0, 4.0, and 8.0 ug/100 ml tissue/min for 2 minutes each.; Nitroprusside will be infused into the brachial catheter while blood flow levels in the forearm are measured. Nitroprusside will be infused at the following doses: 0.25, 0.5, 1.0, and 2.0 ug/100 ml tissue/min for 2 minutes each.; Norepinephrine will be infused into the brachial catheter while blood flow levels in the forearm are measured. Norepinephrine will be infused at the following doses: 1.0, 2.0, 4.0, and 8.0 ug/100 ml tissue/min for 2 minutes each.; A single dose of nitroprusside (100 ug) will be infused through an IV; one minute later, a single dose of phenylephrine (150 ug) will be infused.
Intervention MeSH terms: Nitroprusside; Phenylephrine; Oxymetazoline; Norepinephrine; Acetylcholine
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Premenopausal women, ages 25-50 years old, who have and have not been diagnosed with
        uterine fibroids. Women will be recruited from Rochester, Minnesota and the surrounding
        area (including locations in Iowa and Wisconsin). Women eligible to participate will be in
        good health and not taking medications.
      
Biospecimen description: 
      Whole blood and serum

      No DNA extraction from samples is planned.
    
Keywords: Autonomic nervous system; Blood pressure; Blood vessels; Physiological effects of drugs; Vascular stiffness