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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00975559
Other study ID # 1881-03
Secondary ID
Status Completed
Phase N/A
First received September 9, 2009
Last updated April 25, 2012
Start date September 2003
Est. completion date April 2011

Study information

Verified date April 2012
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 190
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients must be identified in one of the four groups outlined in "study population description."

Exclusion Criteria:

- Other co-morbidities that would make the testing not possible.

- Women who have had a mastectomy and would not have an arm that could be occluded during the reactive hyperemia portion of the Peripheral arterial tonometry testing.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic United States Department of Defense

Country where clinical trial is conducted

United States, 

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