NCT00975559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

April 26, 2012

Status Verified

April 1, 2012

Enrollment Period

7.6 years

First QC Date

September 9, 2009

Last Update Submit

April 25, 2012

Conditions

Study Arms (4)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Catecholomines

MeSH Terms

Conditions

Takotsubo CardiomyopathyMyocardial Infarction

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesVentricular Dysfunction, LeftVentricular DysfunctionMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 11, 2009

Study Start

September 1, 2003

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 26, 2012

Record last verified: 2012-04

Locations