The Relationship Between the Response to Mental Stress and Vascular Endothelial Function

NCT ID: NCT00975559

Last Updated: 2012-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-09-30

Study Completion Date

2011-04-30

Brief Summary

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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

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Conditions

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Coronary Endothelial Dysfunction Apical Ballooning Syndrome Myocardial Infarction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal volunteers

Normal study volunteers with no prior history of coronary artery disease

No interventions assigned to this group

Apical Ballooning Syndrome

Women who have had a documented Apical Ballooning event as shown by coronary angiogram

No interventions assigned to this group

Coronary Endothelial Dysfunction

Patients who have been diagnosed with Endothelial Dysfunction via a coronary angiogram with acetylcholine challenge

No interventions assigned to this group

Myocardial Infarction

Women diagnosed with a Myocardial Infarction who subsequently had a Percutaneous Intervention

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Amir Lerman

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1881-03

Identifier Type: -

Identifier Source: org_study_id

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