Cerebrovascular Health and Resilience in Midlife
CHARM
2 other identifiers
interventional
450
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2023
CompletedFirst Posted
Study publicly available on registry
September 8, 2023
CompletedStudy Start
First participant enrolled
October 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
September 16, 2026
September 1, 2026
5.7 years
August 31, 2023
September 14, 2026
Conditions
Outcome Measures
Primary Outcomes (7)
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.
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
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).
Derived from one acquisition sequence within in a 50 min multimodal MRI protocol
Hippocampal volume
Total bilateral hippocampal volume will be computed as the total sum of voxels automatically segmented.
Derived from one acquisition sequence within a 50 min multimodal MRI protocol
Perivascular space volume
Total perivascular space volume will be computed from segmented brain blood vessel-tissue interfaces.
Derived from one acquisition sequence in a 50 min multimodal MRI protocol
Pulse wave velocity
Pulse wave velocity in m/s will be assessed by dual impedance cardiography as a non-invasive indicator of arterial stiffness. This measure will be derived from the 5 minute baseline period.
5 minutes
Spontaneous baroreflex sensitivity
Spontaneous baroreflex sensitivity in ms/mmHg will be computed by the sequence method applied to beat-to-beat blood pressure and electrocardiogram recordings.
5 minutes
Endothelial function
Endothelial-dependent vasodilation will be measured non-invasively in a reactive hyperemia protocol using digital thermal monitoring.
15 minutes
Study Arms (1)
Paced Auditory Serial Addition Task
EXPERIMENTALFor the Paced Auditory Serial Addition Task, volunteers are presented with single digit numbers (1-9), and are instructed to add any given number to the previously presented number, and call out the answer. Volunteers are told that their performance is being monitored by research assistants. Volunteers are provided with a signaling device that they can use to discontinue testing. Lastly, participants will be asked to complete brief questionnaires to assess their levels of experienced threat, challenge, valence, arousal, and sense of control.
Interventions
Study 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.
Eligibility Criteria
You may qualify if:
- Able to attend 2 study visits at the University of Pittsburgh campus in Oakland (Pennsylvania)
- Able to read and speak English
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter J Gianaros, PhD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 31, 2023
First Posted
September 8, 2023
Study Start
October 17, 2023
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
June 30, 2029
Last Updated
September 16, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data are anticipated to become available within 12 months after the publication of findings bearing on the Specific Aims of R01HL169990
- Access Criteria
- All presentations and publications will include information on the location of study data and its public accessibility for research use. The criteria for certain requests of de-identified data will involve the completion of a Data Use Agreement, https://www.osp.pitt.edu/osp-teams/clinical-corporate-contract-services/negotiations/data-use-agreements-duas
De-identified individual participant data that comprise primary and secondary study outcomes will be made available with data dictionaries via the University of Pittsburgh's repository, D-Scholarship@Pitt. This repository provides indefinite storage and accessibility. Along with de-identified data, other shared resources will include a description of data collection methods and study code book; a description of the data files; and descriptions of data use conditions. Statistical scripts will be deposited as appropriate following publication of manuscripts bearing on the aims of the study. All publications will include information on the location of study data and accessibility. Requests by researchers for other de-identified data will be facilitated by completion of a Data Use Agreement, as well as provision of a methodologically sound proposal and approval from their institution.