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CompletedNCT00975559Updated Apr 26, 2012

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

An observational study in Coronary Endothelial Dysfunction, Apical Ballooning Syndrome and Myocardial Infarction, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-26.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
190
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Endothelial Dysfunction
  • Apical Ballooning Syndrome
  • Myocardial Infarction
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 190 is below the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Inclusion criteria

  • Patients must be identified in one of the four groups outlined in "study population description."

Exclusion criteria

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
190 participants (actual)
Biospecimen retention
Samples without dna

Groups and 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

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Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00975559
Lead sponsor
Mayo Clinic
Collaborators
United States Department of Defense
Responsible party
Amir Lerman (M.D., Mayo Clinic) — Principal investigator
First posted
Sep 11, 2009
Start date
Sep 2003
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Apr 26, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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