Cerebrovascular Health and Resilience in Midlife
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-59
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able to attend 2 study visits at the University of Pittsburgh campus in Oakland (Pennsylvania)
Able to read and speak English
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Paced Auditory Serial Addition Task
BehavioralStudy volunteers will be asked to complete a 4-minute Paced Auditory Serial Addition Task, which is a standardized task that is widely used to study cardiovascular responses to acute psychological challenges (or stressors) in a laboratory setting.
Treatment groups
450 Participants
are divided into 1 treatment groupGroup A: Paced Auditory Serial Addition TaskExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in systolic blood pressure (SBP) from baseline to task
The mean SBP from the baseline period will be subtracted from the mean of the task period.
Time frame
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 period2
White matter hyperintensity burden
White matter hyperintensity burden will be computed as the total sum of the voxels segmented as hyperintensities multiplied by voxel dimensions to yield a total score (units of mm-cubed).
Time frame
Derived from one acquisition sequence within in a 50 min multimodal MRI protocol3
Hippocampal volume
Total bilateral hippocampal volume will be computed as the total sum of voxels automatically segmented.
Time frame
Derived from one acquisition sequence within a 50 min multimodal MRI protocol4
Perivascular space volume
Total perivascular space volume will be computed from segmented brain blood vessel-tissue interfaces.
Time frame
Derived from one acquisition sequence in a 50 min multimodal MRI protocolSponsors and contacts
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University of Pittsburgh
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov