Clinical trial NCT06029348: Cerebrovascular Health and Resilience in Midlife
Official title: Cerebrovascular Health and Resilience in Midlife
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Stress
Cardiovascular Diseases
Cerebrovascular Disorders
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-09-08
Enrollment: 450
Sex: ALL
Minimum age (years): 40
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is designed to measure cardiovascular responses to brief (\~4 minute) mental arithmetic task (a psychological challenge) under laboratory conditions. Cardiovascular activity will be measured during (1) a resting period prior to the task (\~5min), then (2) during the task(\~4 min), and then (3) after the task is complete (\~10min) for all study volunteers. Cardiovascular responses will be examine in relation to other study outcome measures.
Primary purpose: BASIC_SCIENCE

Brief summary: This study examines cardiovascular responses to a brief psychological challenge under laboratory conditions among adult volunteers. The study volunteers are asked to complete two study sessions. In one session, the volunteers are asked to provide demographic and health-related information via questionnaires and an interview. In that session, volunteers would then be asked to undergo evaluations of their body composition, blood pressure, heart rate, and other signs of cardiovascular function and health. Lastly, volunteers would be asked to take part in a brief and challenging psychological task after a period of rest while cardiovascular activity is measured. In the other session, volunteers are asked to undergo magnetic resonance imaging and to complete neuropsychological tests of memory, attention, and processing speed. In addition to these two sessions, volunteers are asked to complete online questionnaires. The study is designed to examine associations between transient changes in cardiovascular activity induced by the psychological task, measures of overall cardiovascular health, and measures of cerebrovascular health measured by magnetic resonance imaging. Study results are expected to provide new information about the relationships between cardiovascular activity changes to psychological challenges and cardiovascular and cerebrovascular health in adults.

Detailed description: This cross-sectional study examines the extent to which cardiovascular responses to the acute experience of psychological stress relate to signs of cerebrovascular health detected on magnetic resonance imaging. Study volunteers will include midlife adults who do not report having a history of clinical cardiovascular disease or dementia. Study volunteers will be asked to complete protocols to assess: behavioral, social, and biological correlates of cardiovascular and cerebrovascular health; arterial stiffness, endothelial function, and beat-to-beat blood pressure; cardiovascular changes to acute psychological stress; signs of cerebrovascular health; and, neuropsychological test performance. Cardiovascular responses to acute psychological stress will be examined in relation to indicators of brain function and structure, as well as indicators of cardiac and vascular function. Study results may help to increase knowledge about stress-related factors and cardiovascular sources of brain health.

Eligibility criteria: Inclusion Criteria:

* Able to attend 2 study visits at the University of Pittsburgh campus in Oakland (Pennsylvania)
* Able to read and speak English

Exclusion Criteria:

* Uncontrolled hypertension (systolic blood pressure \>160 or diastolic blood pressure \>100 mmHg)
* Current use of anticonvulsant, anti-Parkinson, neuroleptic, or antipsychotic medications
* Current use of glucocorticoids (e.g., oral prednisone) or ephedrine
* Current chronic conditions of the lungs, liver and kidney, as well as cancer (chemotherapy and radiation) treatment in the past 12 months (allowances are made for non-melanoma skin cancer treatment, controlled asthma, and allergy inhalers)
* Self-reported major neurological disorders or brain injuries (e.g., multiple sclerosis, cerebral palsy, major head injury)
* Self-reported psychotic illnesses (mania, bipolar disorder, schizophrenia)
* Current pregnancy or childbirth within the past 6 months
* Suspected mild cognitive impairment or dementia
* Self reported sleep apnea
* Self-reported history of myocardial infarction, stroke, or revascularization procedures, as well as treatment for cardiac arrhythmias
* Self-reported lack of comfort to undergo MRI testing
* Presence of implants or objects that are unsafe for MRI (e.g., tattooed eyeliner), as well as any other contraindications that would prevent MRI testing
* Self-reported lack of comfort to undergo the laboratory math task

Primary outcomes:
measure: Change in systolic blood pressure (SBP) from baseline to task
timeFrame: Mean SBPs for the computation of change scores will be computed from the average of the 5 min baseline period and average of the 4 min task period
measure: White matter hyperintensity burden
timeFrame: Derived from one acquisition sequence within in a 50 min multimodal MRI protocol
measure: Hippocampal volume
timeFrame: Derived from one acquisition sequence within a 50 min multimodal MRI protocol
measure: Perivascular space volume
timeFrame: Derived from one acquisition sequence in a 50 min multimodal MRI protocol
measure: Pulse wave velocity
timeFrame: 5 minutes
measure: Spontaneous baroreflex sensitivity
timeFrame: 5 minutes
measure: Endothelial function
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Peter J Gianaros, PhD
role: PRINCIPAL_INVESTIGATOR
References: