The Relationship Between the Response to Mental Stress and Vascular Endothelial Function
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Purpose
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 |
|---|
|
Coronary Endothelial Dysfunction Apical Ballooning Syndrome Myocardial Infarction |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | The Relationship Between the Response to Mental Stress and Vascular Endothelial Function |
Catecholomines
| Enrollment: | 190 |
| Study Start Date: | September 2003 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
- Normal volunteers
- Apical Ballooning syndrome as proven during coronary angiogram
- Coronary Endothelial Dysfunction as proven during coronary angiogram
- Women who have had a Myocardial Infarction with subsequent Percutaneous Intervention
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
More Information
No publications provided
| Responsible Party: | Amir Lerman, M.D., Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00975559 History of Changes |
| Other Study ID Numbers: | 1881-03 |
| Study First Received: | September 9, 2009 |
| Last Updated: | April 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on May 23, 2013