Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT02123069
Status:
COMPLETED
Last Update Posted:
2018-03-02
First Post:
2014-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular Function and Uterine Fibroids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000109', 'term': 'Acetylcholine'}, {'id': 'D009599', 'term': 'Nitroprusside'}, {'id': 'D009638', 'term': 'Norepinephrine'}, {'id': 'D010656', 'term': 'Phenylephrine'}], 'ancestors': [{'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005292', 'term': 'Ferricyanides'}, {'id': 'D003486', 'term': 'Cyanides'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D006856', 'term': 'Hydrogen Cyanide'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood and serum\n\nNo DNA extraction from samples is planned.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-01', 'studyFirstSubmitDate': '2014-04-16', 'studyFirstSubmitQcDate': '2014-04-24', 'lastUpdatePostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Female sex hormone levels', 'timeFrame': 'One day (study day)', 'description': 'Blood samples will be collected to measure levels of estrogen and progesterone.'}], 'primaryOutcomes': [{'measure': 'Baseline systolic, diastolic, and mean blood pressures', 'timeFrame': 'One day (study day)'}, {'measure': 'Baseline sympathetic nerve activity', 'timeFrame': 'One day (study day)', 'description': 'Nerve "burst" activity will be measured across 10 minutes.'}], 'secondaryOutcomes': [{'measure': 'Changes in forearm blood flow levels in response to acetylcholine infusion', 'timeFrame': 'One day (study day)'}, {'measure': 'Changes in forearm blood flow levels in response to nitroprusside infusion', 'timeFrame': 'One day (study day)'}, {'measure': 'Changes in forearm blood flow levels in response to norepinephrine infusion', 'timeFrame': 'One day (study day)'}, {'measure': 'Change in blood pressure in response to infusions of nitroprusside and phenylephrine', 'timeFrame': 'One day (study)', 'description': 'An infusion of nitroprusside will be given, followed by an infusion of phenylephrine one minute later.'}, {'measure': 'Pulse wave velocity (an index of vessel stiffness)', 'timeFrame': 'One day (study day)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Autonomic nervous system', 'Blood pressure', 'Blood vessels', 'Physiological effects of drugs', 'Vascular stiffness'], 'conditions': ['Leiomyoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nIndividuals 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.\n\nScreen Day:\n\nOne 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.\n\nStudy Day:\n\nThe 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women 25-50 years old\n* Premenopausal\n\nExclusion Criteria:\n\n* Postmenopausal\n* Pregnant or currently breastfeeding\n* Using blood pressure medications or anti-depression medications\n* High blood pressure\n* Diabetes\n* Disease in the kidneys, lungs, or blood vessels\n* Chronic diseases (for example: Crohn's disease, rheumatoid arthritis, bipolar mood disorder, etc.)\n* Smoker\n* High cholesterol\n* BMI higher than 30"}, 'identificationModule': {'nctId': 'NCT02123069', 'briefTitle': 'Vascular Function and Uterine Fibroids', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Sympathetic Nerve Activity and Vascular Function in Women With Uterine Leiomyomata', 'orgStudyIdInfo': {'id': '13-000596'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with uterine fibroids', 'description': '* Brachial artery catheter\n* Acetylcholine\n* Nitroprusside\n* Norepinephrine\n* Nitroprusside and phenylephrine', 'interventionNames': ['Device: Brachial artery catheter', 'Drug: Acetylcholine', 'Drug: Nitroprusside', 'Drug: Norepinephrine', 'Drug: Nitroprusside and phenylephrine']}, {'label': 'Women without uterine fibroids', 'description': '* Brachial artery catheter\n* Acetylcholine\n* Nitroprusside\n* Norepinephrine\n* Nitroprusside and phenylephrine', 'interventionNames': ['Device: Brachial artery catheter', 'Drug: Acetylcholine', 'Drug: Nitroprusside', 'Drug: Norepinephrine', 'Drug: Nitroprusside and phenylephrine']}], 'interventions': [{'name': 'Brachial artery catheter', 'type': 'DEVICE', 'description': 'A catheter will be placed in the brachial artery by a physician on the study day.', 'armGroupLabels': ['Women with uterine fibroids', 'Women without uterine fibroids']}, {'name': 'Acetylcholine', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Women with uterine fibroids', 'Women without uterine fibroids']}, {'name': 'Nitroprusside', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Women with uterine fibroids', 'Women without uterine fibroids']}, {'name': 'Norepinephrine', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Women with uterine fibroids', 'Women without uterine fibroids']}, {'name': 'Nitroprusside and phenylephrine', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Women with uterine fibroids', 'Women without uterine fibroids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Michael J Joyner, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Michael J. Joyner, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}