The Relationship Between the Response to Mental Stress an... | NCT00975559

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

NCT00975559

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Apr 26, 2012Estimated

Enrollment

190Actual

Phase

Not provided

Conditions

Coronary Endothelial Dysfunction
Apical Ballooning Syndrome
Myocardial Infarction

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Sep 9, 2009

First Submission Date that Met QC Criteria

Sep 10, 2009

First Posted Date

Sep 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2012

Last Update Posted Date

Apr 26, 2012Estimated

Name	Class
United States Department of Defense	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

190Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

Condition Browse Module

MeSH Terms

ID	Term
D054549	Takotsubo Cardiomyopathy
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D009202	Cardiomyopathies
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D018487	Ventricular Dysfunction, Left

Browse Leaves

Not provided

Browse Branches

Not provided