Cerebrovascular Health and Resilience in Midlife

Cardiovascular Diseases Clinical Trial

— CHARM  

Official title:

Cerebrovascular Health and Resilience in Midlife

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029348
• Other study ID #: STUDY23030073
• Secondary ID: R01HL169990
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: June 30, 2029

Study information

• Verified date: October 2023
• Source: University of Pittsburgh
• Contact: Peter J Gianaros, PhD
• Phone: 412-624-4500
• Email: bnl[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cerebrovascular Disorders
• Psychological Stress
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Endothelial function	Endothelial-dependent vasodilation will be measured non-invasively in a reactive hyperemia protocol using digital thermal monitoring.	15 minutes