Cerebrovascular Health and Resilience in Midlife (CHARM)

University of Pittsburgh

Status: Enrolling

Conditions: Psychological Stress; Cardiovascular Diseases; Cerebrovascular Disorders

Treatments: Behavioral: Paced Auditory Serial Addition Task

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06029348

STUDY23030073

R01HL169990 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 40 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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450 participants in 1 patient group

Paced Auditory Serial Addition Task

Experimental group

Description:

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.

Treatment:

Behavioral: Paced Auditory Serial Addition Task