We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00975559
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : April 26, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Coronary Endothelial Dysfunction Apical Ballooning Syndrome Myocardial Infarction

Study Design

Study Type : Observational
Actual Enrollment : 190 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Relationship Between the Response to Mental Stress and Vascular Endothelial Function
Study Start Date : September 2003
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Biospecimen Retention:   Samples Without DNA
Catecholomines

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  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
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975559


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
United States Department of Defense
More Information

Responsible Party: Amir Lerman, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00975559     History of Changes
Other Study ID Numbers: 1881-03
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: April 26, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Stress, Psychological
Takotsubo Cardiomyopathy
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Behavioral Symptoms
Ventricular Dysfunction, Left
Ventricular Dysfunction