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Effect of Mental Stress on Platelet Function

Primary Purpose

Mental Stress

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
2-minute Bondet test
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Stress focused on measuring mental stress, platelet adhesion, platelet function, catecholamines

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital of Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Young subjects

Older subjects

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of platelet function (shear stress dependent platelet adhesion and aggregation) before and after mental stress

Secondary Outcome Measures

Evaluation of the plasma level of endothelin, catecholamines and salivary cortisol level before and after mental stress

Full Information

First Posted
October 2, 2007
Last Updated
February 9, 2010
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT00538707
Brief Title
Effect of Mental Stress on Platelet Function
Official Title
Effect of Mental Stress on Platelet Function in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Stress
Keywords
mental stress, platelet adhesion, platelet function, catecholamines

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Young subjects
Arm Type
Experimental
Arm Title
Older subjects
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
2-minute Bondet test
Other Intervention Name(s)
2-minute Bondet light test
Intervention Description
2-minute Bondet test
Primary Outcome Measure Information:
Title
Evaluation of platelet function (shear stress dependent platelet adhesion and aggregation) before and after mental stress
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Evaluation of the plasma level of endothelin, catecholamines and salivary cortisol level before and after mental stress
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Noll, MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Zurich
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

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Effect of Mental Stress on Platelet Function

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