Development of a Clinically-relevant Test for Assessment of Cerebral Vascular Function

NCT04336852 | Terminated

• 3 other identifiers: 2020-03181F32HL144082-01A15F32HL144082-02
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to develop a test of cerebral vessel function by inducing a reactive hyperemia that will elicit a rapid and profound increase in cerebral vessel shear stress. The results of this project may lead to development of a test with prognostic/predictive utility for individual risk assessment of a future cerebrovascular event/disease. This information will be of vital importance to the medical community in regards to cerebrovascular health in aging individuals, and testing of interventions and therapies that may ameliorate these effects.

Conditions

Cerebrovascular Disorders; Cerebrovascular Disease

Keywords

brain blood flow; brain vascular function

Outcome Measures

Primary Outcomes (3)

• Cerebral vascular function

  Assessment of internal carotid artery dilation and blood flow in response to a reactive hyperemic stimulus

  3-months

• Cerebral vascular reactivity to carbon dioxide (CO2)

  Assessment of blood flow (or velocity) through the internal carotid artery and middle cerebral artery with a standardized CO2 stimulus (+5 mmHg)

  3-months

• Flow mediated dilation (brachial and femoral arteries)

  Assessment of artery dilation and blood flow in response to a reactive hyperemic stimulus

  3-months

Study Arms (1)

Arm 1

EXPERIMENTAL

Procedure: Flow mediated dilation (brachial and femoral arteries); Procedure: Cerebral vascular reactivity to carbon dioxide (CO2); Procedure: Cerebral vascular function test

Interventions

Flow mediated dilation (brachial and femoral arteries) PROCEDURE

Assessment of vascular function of the brachial and femoral arteries.

Arm 1

Cerebral vascular reactivity to carbon dioxide (CO2) PROCEDURE

Cerebral blood flow responses to increasing partial pressure of CO2

Arm 1

Cerebral vascular function test PROCEDURE

Cerebral blood flow responses to a reactive hyperemia stimulus

Arm 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Young and Older Healthy Adults:
• Males and females willing and able to provide informed consent
• Aged between 18-35 years (Young) or 60-80 years (Older)
• Premenopausal women will be tested within 1-4 days after menses begins to control for hormone status
• Women taking oral contraceptives will be allowed to participate and they will be tested in the low hormone or placebo phase
• Postmenopausal women (at least 12 months since last menstrual cycle) who are not on hormone replacement therapy will be eligible
• Sedentary or recreationally active
• Non-tobacco/nicotine users (e.g., cigarettes, chewing tobacco, nicotine gum or patches)
• Laboratory measured systolic blood pressure \<140 mmHg and diastolic blood pressure \<90 mmHg
• Normal 12-lead ECG (reviewed by a physician)
• Normal clinical results from a medical exam reviewed by a board certified physician (e.g., Medical \& Behavioral Health Questionnaire - see attached document)
• Body mass index (BMI) \<40 kg/m2 unless athletic/muscular build; calculation = body weight (kg)/height (m2); this criteria is used to ensure subjects will fit inside the LBNP chamber
• Females only: documentation of a negative pregnancy test prior to the familiarization and experimental sessions
• Young and Older Chronic Smokers of Tobacco Cigarettes:
• The same criteria (a-c and e-i above) as Young and Older Healthy Adults, except:

You may not qualify if:

• Young and Older Healthy Adults:
• Age \<18 years, or 40-60 years, or \>80 years
• Body mass index (BMI) \>40 kg/m2 unless athletic/muscular build; calculation = body weight (kg)/height (m2)
• Regular tobacco/nicotine users within the last 6 months (e.g., cigarettes, chewing tobacco, nicotine gum or patches)
• Not abstaining from the following 24 hours prior to the familiarization session and the experimental session: exercise, alcoholic substances, prescription or non-prescription medications (unless cleared by the medical screener), dietary supplements, herbal medications, caffeinated substances (including coffee, tea (iced or hot), caffeinated energy drinks or sodas).
• Not fasted for at least 3-4 hours prior to the experimental sessions.
• Positive pregnancy test
• Hormone replacement therapy (males and females)
• Females with an erratic/irregular menstrual cycle
• Females who are using a continually-releasing hormonal (e.g., NuvaRing™ or other hormone-releasing vaginal rings, Depo Provera shot, birth control implants such as Nexplanon) and who do not have a regular menstrual cycle
• Use of prescription drugs, non-prescription drugs or herbal medicines known to alter autonomic function unless cleared prior to the study
• Any metabolic disease, except individuals who are on cholesterol-lowering medications (older subjects only; young subjects on cholesterol-lowering medications will be excluded)
• Use of two or more anti-hypertensive medications (older subjects only; young subjects on anti-hypertensive medications will be excluded)
• Use of beta blockers
• Frequent use of bronchodilators

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

Location

MeSH Terms

Conditions

Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alexander J Rosenberg, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three groups of subjects (young, older, cigarette smokers) complete the same intervention, in an independent-group design.

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 7, 2020
• Study Start: September 14, 2018
• Primary Completion: May 12, 2023
• Study Completion: May 12, 2023
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)