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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Coronary Endothelial Dysfunction; Apical Ballooning Syndrome

• Study Type: Observational
• Enrollment (Actual): 190

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (ACTUAL): April 1, 2011
• Study Completion (ACTUAL): April 1, 2011

Study Registration Dates

• First Submitted: September 9, 2009
• First Submitted That Met QC Criteria: September 10, 2009
• First Posted (ESTIMATE): September 11, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): April 26, 2012
• Last Update Submitted That Met QC Criteria: April 25, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Myocardial Infarction; Infarction; Stress, Psychological; Takotsubo Cardiomyopathy
• Other Study ID Numbers: 1881-03