Cerebrovascular Health and Resilience in Midlife

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-17

Study Completion Date

2029-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Positive Psychology to Improve Healthy Behaviors After an Acute Coronary Syndrome

NCT02004158

Acute Coronary Syndrome

COMPLETED NA

Mind-body Interventions in Cardiac Patients

NCT01270568

Acute Coronary Syndrome Congestive Heart Failure

COMPLETED NA

Improving Well-Being for Older Adult Family Dementia Caregivers

NCT03881631

Stress, Psychological

COMPLETED NA

Physical Health in Midlife: Influences of Adversity and Relationships Over Time

NCT01853332

Cardiovascular Disease Type 2 Diabetes

COMPLETED

Researching Emotions And Cardiac Health: Phase III

NCT03220204

Congestive Heart Failure Emotions Patient Compliance

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psychological Stress Cardiovascular Diseases Cerebrovascular Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Paced Auditory Serial Addition Task

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes