AzTrials
AzTrials

Cerebrovascular DisordersNCT04336852

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

A study testing Flow mediated dilation (brachial and femoral arteries), Cerebral vascular reactivity to carbon dioxide (CO2) and Cerebral vascular function test in people with Cerebrovascular Disorders and Cerebrovascular Disease, run by University of Illinois Chicago at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
Flow mediated dilation (brachial and femoral arteries), Cerebral vascular reactivity to carbon dioxide (CO2) and Cerebral vascular function test
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
2 sitesUnited States
Study dates
14 Sep 2018to 12 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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:
  • Chronic smokers of tobacco cigarettes only (i.e., at least 20 pack year use)

Who cannot join

  • 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.
Show all 34Show fewer
  • 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
  • Use of anti-coagulant therapy
  • Current or past history of hyperthyroidism, or other thyroid hormone-related disease
  • Signs of cardiovascular abnormalities (e.g., resting systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg; abnormal 12-lead ECG)
  • History of cerebrovascular abnormalities (e.g., prior stroke, transient ischemic attacks, epilepsy)
  • Known history of atherosclerosis of the carotid arteries (i.e., plaque formation)
  • Known history of peripheral artery disease (PAD)
  • Concussion and or other loss of consciousness within the past 30 days.
  • Autonomic dysfunction (e.g., Shy-Drager Syndrome, Bradbury-Eggleston syndrome, sinus arrhythmia, idiopathic orthostatic hypotension, fainting disorder)
  • Respiratory illnesses (e.g., chronic asthma (including exercise-induced asthma), Chronic Obstructive Pulmonary Disease, Reactive Airway Disease)
  • History of anaphylaxis
  • History of pre-syncopal/syncopal episodes or orthostatic hypotension
  • Donated blood within the last 60 days
  • History or family history of abnormal blood clotting, clots in deep veins in the legs or pelvis, or blood clots to the lungs
  • Known or suspected abdominal hernia
  • History of alcohol or drug abuse which inhibits the subject's ability to complete this study
  • Known depression, anxiety, or any other mental health issue which inhibits the subject's ability to complete this study
  • Young and Older Chronic Smokers of Tobacco Cigarettes
  • The same criteria (a-b and d-dd above) as Young and Older Healthy Adults, except:
  • Less than 20 pack year use of tobacco cigarettes, or regular use of other tobacco/nicotine products within the last 6 months (e.g., electronic cigarettes, chewing tobacco, nicotine gum or patches).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • University of North Texas Health Science Center

    Fort Worth, Texas, 76107

Other trials in United States

About this study

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.

Being tested
Flow mediated dilation (brachial and femoral arteries), Cerebral vascular reactivity to carbon dioxide (CO2), Cerebral vascular function test
Keywords
brain blood flow, brain vascular function
Medical subject headings
Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flow mediated dilation (brachial and femoral arteries)Procedure or surgery

    Assessment of vascular function of the brachial and femoral arteries.

  • Cerebral vascular reactivity to carbon dioxide (CO2)Procedure or surgery

    Cerebral blood flow responses to increasing partial pressure of CO2

  • Cerebral vascular function testProcedure or surgery

    Cerebral blood flow responses to a reactive hyperemia stimulus

Study groups in NCT04336852
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Procedure: Flow mediated dilation (brachial and femoral arteries); Procedure: Cerebral vascular reactivity to carbon dioxide (CO2); Procedure: Cerebral vascular function test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cerebral vascular function

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

    Measured: 3-months

  2. 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)

    Measured: 3-months

  3. Flow mediated dilation (brachial and femoral arteries)

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

    Measured: 3-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2020
  2. Study start14 Sep 2018
  3. Primary completion12 May 2023
  4. Study completion12 May 2023

Why it stopped: Administratively Closed-PI left institution

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Three groups of subjects (young, older, cigarette smokers) complete the same intervention, in an independent-group design.
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04336852
Sponsor's protocol ID
2020-0318
Other IDs
1F32HL144082-01A1, 5F32HL144082-02
Status last verified
May 2025
First submitted
1 Apr 2020
Last updated
20 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Flow mediated dilation (brachial and femoral arteries), Cerebral vascular reactivity to carbon dioxide (CO2) and Cerebral vascular function test in people with Cerebrovascular Disorders and Cerebrovascular Disease, run by University of Illinois Chicago at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Administratively Closed-PI left institution). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cerebral vascular function (time frame: 3-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04336852.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in