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Effect of Mental Stress on Platelet Function

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ClinicalTrials.gov Identifier: NCT00538707
Recruitment Status : Completed
First Posted : October 3, 2007
Last Update Posted : February 10, 2010
Sponsor:
Information provided by:
University of Zurich

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Mental Stress Behavioral: 2-minute Bondet test Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Mental Stress on Platelet Function in Healthy Subjects
Study Start Date : September 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Young subjects Behavioral: 2-minute Bondet test
2-minute Bondet test
Other Name: 2-minute Bondet light test
Experimental: Older subjects Behavioral: 2-minute Bondet test
2-minute Bondet test
Other Name: 2-minute Bondet light test


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Evaluation of platelet function (shear stress dependent platelet adhesion and aggregation) before and after mental stress [ Time Frame: 60 minutes ]

Secondary Outcome Measures :
  1. Evaluation of the plasma level of endothelin, catecholamines and salivary cortisol level before and after mental stress [ Time Frame: 60 minutes ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538707


Locations
Switzerland
University Hospital of Zurich
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Georg Noll, MD University of Zurich
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Zurich, University Hospital Zurich
ClinicalTrials.gov Identifier: NCT00538707     History of Changes
Other Study ID Numbers: EK-1382
First Posted: October 3, 2007    Key Record Dates
Last Update Posted: February 10, 2010
Last Verified: February 2010

Keywords provided by University of Zurich:
mental stress
platelet adhesion
platelet function
catecholamines

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms