Development of a Clinically-relevant Test for Assessment of Cerebral Vascular Function
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1
|
Procedure: Flow mediated dilation (brachial and femoral arteries)
Assessment of vascular function of the brachial and femoral arteries.
Procedure: Cerebral vascular reactivity to carbon dioxide (CO2)
Cerebral blood flow responses to increasing partial pressure of CO2
Procedure: Cerebral vascular function test
Cerebral blood flow responses to a reactive hyperemia stimulus
|
Outcome Measures
Primary Outcome Measures
- Cerebral vascular function [3-months]
Assessment of internal carotid artery dilation and blood flow in response to a reactive hyperemic stimulus
- Cerebral vascular reactivity to carbon dioxide (CO2) [3-months]
Assessment of blood flow (or velocity) through the internal carotid artery and middle cerebral artery with a standardized CO2 stimulus (+5 mmHg)
- Flow mediated dilation (brachial and femoral arteries) [3-months]
Assessment of artery dilation and blood flow in response to a reactive hyperemic stimulus
Eligibility Criteria
Criteria
Inclusion Criteria:
Young and Older Healthy Adults:
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Males and females willing and able to provide informed consent
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Aged between 18-35 years (Young) or 60-80 years (Older)
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Premenopausal women will be tested within 1-4 days after menses begins to control for hormone status
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Women taking oral contraceptives will be allowed to participate and they will be tested in the low hormone or placebo phase
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Postmenopausal women (at least 12 months since last menstrual cycle) who are not on hormone replacement therapy will be eligible
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Sedentary or recreationally active
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Non-tobacco/nicotine users (e.g., cigarettes, chewing tobacco, nicotine gum or patches)
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Laboratory measured systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg
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Normal 12-lead ECG (reviewed by a physician)
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Normal clinical results from a medical exam reviewed by a board certified physician (e.g., Medical & Behavioral Health Questionnaire - see attached document)
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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
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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)
Exclusion Criteria:
Young and Older Healthy Adults:
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Age <18 years, or 40-60 years, or >80 years
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Body mass index (BMI) >40 kg/m2 unless athletic/muscular build; calculation = body weight (kg)/height (m2)
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Regular tobacco/nicotine users within the last 6 months (e.g., cigarettes, chewing tobacco, nicotine gum or patches)
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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).
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Not fasted for at least 3-4 hours prior to the experimental sessions.
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Positive pregnancy test
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Hormone replacement therapy (males and females)
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Females with an erratic/irregular menstrual cycle
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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
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Use of prescription drugs, non-prescription drugs or herbal medicines known to alter autonomic function unless cleared prior to the study
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Any metabolic disease, except individuals who are on cholesterol-lowering medications (older subjects only; young subjects on cholesterol-lowering medications will be excluded)
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Use of two or more anti-hypertensive medications (older subjects only; young subjects on anti-hypertensive medications will be excluded)
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Use of beta blockers
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Frequent use of bronchodilators
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Use of anti-coagulant therapy
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Current or past history of hyperthyroidism, or other thyroid hormone-related disease
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Signs of cardiovascular abnormalities (e.g., resting systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg; abnormal 12-lead ECG)
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History of cerebrovascular abnormalities (e.g., prior stroke, transient ischemic attacks, epilepsy)
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Known history of atherosclerosis of the carotid arteries (i.e., plaque formation)
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Known history of peripheral artery disease (PAD)
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Concussion and or other loss of consciousness within the past 30 days.
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Autonomic dysfunction (e.g., Shy-Drager Syndrome, Bradbury-Eggleston syndrome, sinus arrhythmia, idiopathic orthostatic hypotension, fainting disorder)
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Respiratory illnesses (e.g., chronic asthma (including exercise-induced asthma), Chronic Obstructive Pulmonary Disease, Reactive Airway Disease)
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History of anaphylaxis
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History of pre-syncopal/syncopal episodes or orthostatic hypotension
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Donated blood within the last 60 days
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History or family history of abnormal blood clotting, clots in deep veins in the legs or pelvis, or blood clots to the lungs
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Known or suspected abdominal hernia
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History of alcohol or drug abuse which inhibits the subject's ability to complete this study
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
| 2 | University of North Texas Health Science Center | Fort Worth | Texas | United States | 76107 |
Sponsors and Collaborators
- University of Illinois at Chicago
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Alexander J Rosenberg, PhD, University of Illinois at Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-0318
- 1F32HL144082-01A1
- 5F32HL144082-02