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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL169990 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paced Auditory Serial Addition Task | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter J Gianaros, PhD | Contact | 412-624-4500 | bnl@pitt.edu | |
| Sara Boyko, BS | Contact | 412-648-9047 | bnl@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Peter J Gianaros, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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.
Data are anticipated to become available within 12 months after the publication of findings bearing on the Specific Aims of R01HL169990
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
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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| 5 minutes |
| Endothelial function | Endothelial-dependent vasodilation will be measured non-invasively in a reactive hyperemia protocol using digital thermal monitoring. | 15 minutes |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |