Blood Vessel Anatomy and Blood Flow Regulation

August 8, 2023 updated by: University of Wisconsin, Madison

The Impact of Cerebral Anatomical Variations on Cerebrovascular Reactivity

Brain blood flow regulation will be measured in response to environmental changes using MRI.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Global brain blood flow decreases with advancing age; however, some adults have accelerated declines in brain blood flow, placing them at a greater risk of cognitive impairment. Similarly, brain reactivity to increased levels of carbon dioxide decreases with age, with a greater decline in adults with vascular risk factors and is impaired in early Alzheimer's disease. Preclinical models suggest that reduced brain blood flow, results in low levels of oxygen regionally. Currently, there are a lack of human studies that investigate the cause or consequence of altered blood flow regulation in the brain.

The research aims are:

  1. Determine the impact of vertebral artery hypoplasia (VAH) on brain reactivity to increased levels of carbon dioxide.
  2. Determine the impact of VAH on the brain blood flow response to acute low levels of oxygen.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • University of Wisconsin-Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Subjects for this study, will include healthy adults enrolled in the Wisconsin Alzheimer's Disease Research Clinical Core. Both men and women are eligible to participate in this study.

Description

Inclusion Criteria:

  • BMI ≤38.5 kg/m2
  • Nonsmoker
  • Female subjects: postmenopausal
  • Currently enrolled in the Wisconsin Alzheimer's Disease Research Clinical Core

Exclusion Criteria:

  • Diagnosis of mild cognitive impairment or Alzheimer's disease
  • Uncontrolled hypertension
  • History or evidence of hepatic disease, hematological disease, or peripheral vascular disease
  • Severe kidney injury requiring hemodialysis
  • Cardiovascular disease including: severe congestive heart failure, coronary artery disease, ischemic heart disease (stents, coronary artery bypass grafts) and tachycardia
  • History of clinically significant ischemic or hemorrhagic stroke, or significant cerebrovascular disease
  • History of HIV/AIDS
  • Severe untreated obstructive sleep apnea
  • History of diabetes with HbA1c greater than 9.5%
  • Major neurologic disorders other than dementia (e.g., multiple sclerosis, amyotrophic lateral sclerosis, brain surgery, etc.)
  • Current or recent (<1 year) major psychiatric condition (Axis I) or addictive disorders
  • Contraindications to MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Controls
Healthy controls
Device: MRI
Participants will undergo an MRI scan while participating in two breathing tests (hypercapnia and hypoxia) to measure brain blood flow.
Vertebral Artery Hypoplasia
Healthy individuals with vertebral artery hypoplasia
Device: MRI
Participants will undergo an MRI scan while participating in two breathing tests (hypercapnia and hypoxia) to measure brain blood flow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral Vascular Reactivity to Hypercapnia
Time Frame: One study visit, up to 120 minutes in the MRI
The change in brain blood flow using MRI will be measured in response to a hypercapnic breathing test. The participants cerebral vascular reactivity to hypercapnia will be compared between the controls (without VAH) and those with VAH.
One study visit, up to 120 minutes in the MRI
Cerebral Blood Flow Response to Hypoxia
Time Frame: One study visit, up to 120 minutes in the MRI
The change in brain blood flow using MRI will be measured in response to a hypoxic breathing test. The participants cerebral blood flow response to hypoxia will be compared between the controls (without VAH) and those with VAH.
One study visit, up to 120 minutes in the MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Jill N Barnes, PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-0423
  • A176000 (Other Identifier: University of Wisconsin, Madison)
  • 1RF1NS117746-01 (U.S. NIH Grant/Contract)
  • Protocol Version 4/6/2022 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe