The Relationship Between the Response to Mental Stress and Vascular Endothelial Function
| Tracking Information | |
|---|---|
| First Received Date ICMJE | September 9, 2009 |
| Last Updated Date | April 25, 2012 |
| Start Date ICMJE | September 2003 |
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00975559 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 | The Relationship Between the Response to Mental Stress and Vascular Endothelial Function |
| Official Title ICMJE | The Relationship Between the Response to Mental Stress and Vascular Endothelial Function |
| Brief Summary | The aim of this study is to measure how different people respond to mental stress. The investigators will measure if there are differences in cardiovascular responses to mental stress among different groups of subjects. In one part of the study the investigators will compare the cardiovascular responses to mental stress between healthy women and healthy men. In another part of the study, the investigators will compare the cardiovascular responses to mental stress between women with apical ballooning syndrome and healthy post-menopausal women. The investigators hypothesize that healthy men will have an increased vascular response to and decreased endothelial function in response to to mental stress, compared to health women. Furthermore, the investigators hypothesize that women with apical ballooning syndrome will have an increased vascular response to and decreased endothelial function in response to mental stress. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Retention: Samples Without DNA Description: Catecholomines |
| Sampling Method | Non-Probability Sample |
| Study Population |
|
| Condition ICMJE |
|
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) |
|
| Publications * | Not Provided |
|
* 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 | 190 |
| Completion Date | April 2011 |
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00975559 |
| Other Study ID Numbers ICMJE | 1881-03 |
| Has Data Monitoring Committee | No |
| Responsible Party | Amir Lerman, Mayo Clinic |
| Study Sponsor ICMJE | Mayo Clinic |
| Collaborators ICMJE | Department of Defense |
| Investigators ICMJE | Not Provided |
| Information Provided By | Mayo Clinic |
| Verification Date | April 2012 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|