Blood Vessel Anatomy and Blood Flow Regulation

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05396287

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

Enrollment

Location

22.4

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Brain Blood Flow Healthy	Device: MRI

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:

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

The Impact of Cerebral Anatomical Variations on Cerebrovascular Reactivity

Actual Study Start Date :

Jul 19, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Cerebral Vascular Reactivity to Hypercapnia [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.
Cerebral Blood Flow Response to Hypoxia [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 69 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

BMI ≤35 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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin-Madison	Madison	Wisconsin	United States	53706

Sponsors and Collaborators

University of Wisconsin, Madison
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of Wisconsin, Madison

ClinicalTrials.gov Identifier:

NCT05396287

Other Study ID Numbers:

2020-0423
1RF1NS117746-01
Protocol Version 4/6/2022
A176000

First Posted:

May 31, 2022

Last Update Posted:

Jul 21, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Wisconsin, Madison

MRI

Brain blood flow

Study Results

No Results Posted as of Jul 21, 2022