The Relationship Between the Response to Mental Stress and Vascular Endothelial Function
1 other identifier
observational
190
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2003
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 9, 2009
CompletedFirst Posted
Study publicly available on registry
September 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedApril 26, 2012
April 1, 2012
7.6 years
September 9, 2009
April 25, 2012
Conditions
Study Arms (4)
Normal volunteers
Normal study volunteers with no prior history of coronary artery disease
Apical Ballooning Syndrome
Women who have had a documented Apical Ballooning event as shown by coronary angiogram
Coronary Endothelial Dysfunction
Patients who have been diagnosed with Endothelial Dysfunction via a coronary angiogram with acetylcholine challenge
Myocardial Infarction
Women diagnosed with a Myocardial Infarction who subsequently had a Percutaneous Intervention
Eligibility Criteria
1. Normal volunteers 2. Apical Ballooning syndrome as proven during coronary angiogram 3. Coronary Endothelial Dysfunction as proven during coronary angiogram 4. Women who have had a Myocardial Infarction with subsequent Percutaneous Intervention
You may qualify if:
- Patients must be identified in one of the four groups outlined in "study population description."
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- United States Department of Defensecollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Biospecimen
Catecholomines
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
September 9, 2009
First Posted
September 11, 2009
Study Start
September 1, 2003
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
April 26, 2012
Record last verified: 2012-04