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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00975559
First received: September 9, 2009
Last updated: April 25, 2012
Last verified: April 2012

September 9, 2009
April 25, 2012
September 2003
April 2011   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00975559 on ClinicalTrials.gov Archive Site
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The Relationship Between the Response to Mental Stress and Vascular Endothelial Function
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Catecholomines

Non-Probability Sample
  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
  • Coronary Endothelial Dysfunction
  • Apical Ballooning Syndrome
  • Myocardial Infarction
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
April 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00975559
1881-03
No
Amir Lerman, Mayo Clinic
Mayo Clinic
Department of Defense
Not Provided
Mayo Clinic
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP