CHARM: Cerebrovascular Health and Resilience in Midlife

Sponsor
University of Pittsburgh (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06029348
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
450
1
1
69.4
6.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Paced Auditory Serial Addition Task
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
450 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Cerebrovascular Health and Resilience in Midlife
Anticipated Study Start Date :
Sep 18, 2023
Anticipated Primary Completion Date :
Jun 30, 2029
Anticipated Study Completion Date :
Jun 30, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Paced Auditory Serial Addition Task

For 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.

Behavioral: Paced Auditory Serial Addition Task
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.

Outcome Measures

Primary Outcome Measures

  1. Change in systolic blood pressure (SBP) from baseline to task [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]

    The mean SBP from the baseline period will be subtracted from the mean of the task period.

  2. White matter hyperintensity burden [Derived from one acquisition sequence within in a 50 min multimodal MRI protocol]

    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).

  3. Hippocampal volume [Derived from one acquisition sequence within a 50 min multimodal MRI protocol]

    Total bilateral hippocampal volume will be computed as the total sum of voxels automatically segmented.

  4. Perivascular space volume [Derived from one acquisition sequence in a 50 min multimodal MRI protocol]

    Total perivascular space volume will be computed from segmented brain blood vessel-tissue interfaces.

  5. Pulse wave velocity [5 minutes]

    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.

  6. Spontaneous baroreflex sensitivity [5 minutes]

    Spontaneous baroreflex sensitivity in ms/mmHg will be computed by the sequence method applied to beat-to-beat blood pressure and electrocardiogram recordings.

  7. Endothelial function [15 minutes]

    Endothelial-dependent vasodilation will be measured non-invasively in a reactive hyperemia protocol using digital thermal monitoring.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pittsburgh Pittsburgh Pennsylvania United States 15213

Sponsors and Collaborators

  • University of Pittsburgh
  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Peter J Gianaros, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peter Gianaros, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT06029348
Other Study ID Numbers:
  • STUDY23030073
  • R01HL169990
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 8, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2023