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Medications for Cerebral Blood Flow Regulation (Gas Challenge Trial)

Phase < 1
Recruiting
Led By William Schrage, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants will be healthy adults between 18-40 years old, matched for age and aerobic fitness
Women must have a natural regular menstrual cycle
Must not have
Participants with a history of stroke
Participants with a history of hematologic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 75 minutes for entire visit, but hypercapnia lasts about 10-15 minutes

Summary

This trial is testing whether men and women have different ways of controlling blood flow to the brain. The stress is low oxygen or high carbon dioxide. The study will use medicine infusions during stress and MRI to measure brain blood flow.

Who is the study for?
Healthy adults aged 18-40 with normal blood pressure, body mass index (BMI) between 19-25, regular menstrual cycles for women, and good cholesterol levels. Excluded are those with a history of stroke, diabetes, kidney or blood diseases, obesity, sleep apnea; smokers; users of hormonal birth control or cardiovascular meds; pregnant women; and anyone unable to undergo MRI.
What is being tested?
The study is examining how men and women regulate brain blood flow at rest and under stress from low oxygen or high carbon dioxide. It involves infusions of Ganirelix Acetate, L-NMMA, Ketorolac Tromethamine along with Estradiol Topical for women and Testosterone Transdermal Product for men while using advanced MRI to measure changes in cerebral blood flow.
What are the potential side effects?
Potential side effects may include reactions at the infusion site such as pain or swelling, hormone-related effects like mood swings or skin changes due to topical estradiol/testosterone application. The impact on organ function will be monitored closely during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy adult aged 18-40 with good aerobic fitness.
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I have a regular menstrual cycle without any interventions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a stroke in the past.
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I have a history of blood disorders.
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I have a history of kidney disease.
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I have a history of sleep apnea.
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I have a history of peripheral vascular disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 75 minutes for entire visit, but hypercapnia lasts about 10-15 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 75 minutes for entire visit, but hypercapnia lasts about 10-15 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CVC change in response to Drug Infusion
CVC in response to Hypercapnia
Cerebrovascular Conductance (CVC) in response to Hypoxia
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Male NOSExperimental Treatment4 Interventions
Males visit MRI twice. Once for indomethacin visit (hypoxia + hypercapnia), and once for placebo visit (hypoxia + hypercapnia). We will conduct these 2 MRI visits in a double-blind placebo controlled design. CBF measured via MRI sequences, and hemodynamics monitored for safety/research.
Group II: Male COXExperimental Treatment4 Interventions
Males visit MRI twice. Once for indomethacin visit (hypoxia + hypercapnia), and once for placebo visit (hypoxia + hypercapnia). We will conduct these 2 MRI visits in a double-blind placebo controlled design. CBF measured via MRI sequences, and hemodynamics monitored for safety/research.
Group III: Female NOSExperimental Treatment4 Interventions
Females visit MRI twice. Once for indomethacin visit (hypoxia + hypercapnia), and once for placebo visit (hypoxia + hypercapnia). We will conduct these 2 MRI visits in a double-blind placebo controlled design. CBF measured via MRI sequences, and hemodynamics monitored for safety/research.
Group IV: Female COXExperimental Treatment4 Interventions
Females visit MRI twice. Once for indomethacin visit (hypoxia + hypercapnia), and once for placebo visit (hypoxia + hypercapnia). We will conduct these 2 MRI visits in a double-blind placebo controlled design. CBF measured via MRI sequences, and hemodynamics monitored for safety/research.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antacid
2021
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,231 Previous Clinical Trials
3,199,774 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,792,220 Total Patients Enrolled
William Schrage, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
2 Previous Clinical Trials
38 Total Patients Enrolled

Media Library

Male COX Clinical Trial Eligibility Overview. Trial Name: NCT04265053 — Phase < 1
Cerebral Artery Disease Research Study Groups: Male COX, Male NOS, Female COX, Female NOS
Cerebral Artery Disease Clinical Trial 2023: Male COX Highlights & Side Effects. Trial Name: NCT04265053 — Phase < 1
Male COX 2023 Treatment Timeline for Medical Study. Trial Name: NCT04265053 — Phase < 1
~9 spots leftby Mar 2025
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