Effect of Mental Stress on Platelet Function | NCT00538707

Studies
Effect of Mental Stress on Platelet Function

NCT00538707

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Feb 10, 2010Estimated

Enrollment

32Estimated

Phase

Not Applicable

Conditions

Mental Stress

Interventions

2-minute Bondet test

Countries

Switzerland

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

Feb 2010

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 2007

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Oct 2, 2007

First Submission Date that Met QC Criteria

Oct 2, 2007

First Posted Date

Oct 3, 2007Estimated

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

Feb 9, 2010

Last Update Posted Date

Feb 10, 2010Estimated

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 the project is to study the acute and chronic effect of mental stress on platelet adhesion and aggregation in two population composed of normal subjects at different ages

Detailed Description

Psychological stress is an important cardiovascular risk factor. Activation of platelets plays an important role in atherosclerosis development and it could be one of the mechanisms linking psychological stress and cardiovascular diseases.

We plan to include 32 healthy subjects. (16 in every group). One group with subjects at age 20 - 49 and the other group with subjects at age 50 - 70 years.

The aim of the study will be to assess the acute and chronic effect of a standard short mental stress (2-minute Bondet Test) on platelet function and of the level of endothelin-1, catecholamines and cortisol. We plan to evaluate if age may play a role in the effect of psychological stress on platelet function.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Young subjects	Experimental		Behavioral: 2-minute Bondet test
Older subjects	Experimental		Behavioral: 2-minute Bondet test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
2-minute Bondet test	Behavioral	2-minute Bondet test	Older subjects Young subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of platelet function (shear stress dependent platelet adhesion and aggregation) before and after mental stress		60 minutes

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of the plasma level of endothelin, catecholamines and salivary cortisol level before and after mental stress		60 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy subjects between 20 - 70 years of age
written informed consent
no evidence of diseases

Exclusion Criteria:

pregnancy
oral contraceptives
smoking
use of aspirin or NSAIDs within the last week
use of benzodiazepines within the last week
Alcohol or drug abuse
participation in another study within the last month

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georg Noll, MD	University of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Zurich		Zurich			Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D013315	Stress, Psychological

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided