Cerebrovascular Health and Resilience in Midlife (CHARM)

September 22, 2025 updated by: Peter Gianaros, University of Pittsburgh
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Peter J Gianaros, PhD
  • Phone Number: 412-624-4500
  • Email: bnl@pitt.edu

Study Contact Backup

  • Name: Sara Boyko, BS
  • Phone Number: 412-648-9047
  • Email: bnl@pitt.edu

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh
        • Contact:
          • Sara Boyko, BS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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).
Derived from one acquisition sequence within in a 50 min multimodal MRI protocol
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.
Derived from one acquisition sequence within a 50 min multimodal MRI protocol
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.
Derived from one acquisition sequence in a 50 min multimodal MRI protocol
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.
5 minutes
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.
5 minutes
Endothelial function
Time Frame: 15 minutes
Endothelial-dependent vasodilation will be measured non-invasively in a reactive hyperemia protocol using digital thermal monitoring.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter J Gianaros, PhD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY23030073
  • R01HL169990 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data that comprise primary and secondary study outcomes will be made available with data dictionaries via the University of Pittsburgh's repository, D-Scholarship@Pitt. This repository provides indefinite storage and accessibility. Along with de-identified data, other shared resources will include a description of data collection methods and study code book; a description of the data files; and descriptions of data use conditions. Statistical scripts will be deposited as appropriate following publication of manuscripts bearing on the aims of the study. All publications will include information on the location of study data and accessibility. Requests by researchers for other de-identified data will be facilitated by completion of a Data Use Agreement, as well as provision of a methodologically sound proposal and approval from their institution.

IPD Sharing Time Frame

Data are anticipated to become available within 12 months after the publication of findings bearing on the Specific Aims of R01HL169990

IPD Sharing Access Criteria

All presentations and publications will include information on the location of study data and its public accessibility for research use. The criteria for certain requests of de-identified data will involve the completion of a Data Use Agreement, https://www.osp.pitt.edu/osp-teams/clinical-corporate-contract-services/negotiations/data-use-agreements-duas

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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