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NCT Number: NCT06029348

Cerebrovascular Health and Resilience in Midlife

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.

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Key information

Conditions

Psychological Stress Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stress, Psychological Vascular Diseases

Age range

40 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Sara Boyko, BS

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paced Auditory Serial Addition Task

Behavioral

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.

Primary outcomes

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

    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 period

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

  2. White matter hyperintensity burden

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 15 minutes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Peter J Gianaros, PhD

CONTACT

[email protected]

412-624-4500

Sara Boyko, BS

CONTACT

[email protected]

412-648-9047

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: CHARM

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Sep 8, 2023
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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