Mental Stress, Autonomic Function, and Heart Disease
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 25, 2000 | ||||
| Last Updated Date | July 11, 2005 | ||||
| Start Date ICMJE | September 1998 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00005524 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Mental Stress, Autonomic Function, and Heart Disease | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | To examine the vagal, vascular sympathetic, and mechno-structural components of baroreflex regulation in coronary artery disease (CAD) patients and healthy age-matched controls during rest and acute laboratory stress. |
||||
| Detailed Description | BACKGROUND: The strong association between mental stress and morbid cardiovascular events in coronary artery disease (CAD) patients may derive from stress-induced cardiac ischemia due to exaggerated increases in vascular resistance and arterial pressure. In fact, this may explain part of the prognostic relationship of baroreflex cardiac vagal control to cardiovascular outcome among CAD patients. The hemodynamic responses to psychological stress are buffered by the arterial baroreflex; thus, exaggerated pressor responses to mental stress may result from impaired baroreflex regulation in CAD patients. DESIGN NARRATIVE: The study has three components. The first component characterizes the relationships between vascular stiffness and baroreflex regulation among CAD patients, also contrasting healthy control subjects with CAD patients. The second component examines, in relation to individual differences in pharmacologically derived estimates of baroreflex function, changes in autonomic and baroreflex control during laboratory psychological stress among CAD patients and among healthy control subjects. The third component tests the hypothesis that impaired baroreflex regulation in CAD patients, due to increased vascular stiffness and/or attenuated autonomic control, is associated with exacerbated hemodynamic reactions to psychological stress. Bolus vasoactive drug infusions in combination with Finapres beat-by-beat arterial pressures and carotid B-mode ultrasonography are used to evaluate baroreflex sensitivity and arterial stiffness. Baroreflex adjustments to psychological stress are assessed by power spectral-derived relations between arterial pressure and cardiac chronotropy during a mental arithmetic task and a speech task. The degree to which indices of baroreflex function are associated with hemodynamic responses to psychological stress among CAD patients is assessed. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | August 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | No eligibility criteria |
||||
| Gender | Male | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00005524 | ||||
| Other Study ID Numbers ICMJE | 5051 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | July 2005 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||