- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00538707
Effect of Mental Stress on Platelet Function
Effect of Mental Stress on Platelet Function in Healthy Subjects
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Zurich, Switzerland
- University Hospital of Zürich
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Young subjects
|
2-minute Bondet test
Other Names:
|
Experimental: Older subjects
|
2-minute Bondet test
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of platelet function (shear stress dependent platelet adhesion and aggregation) before and after mental stress
Time Frame: 60 minutes
|
60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of the plasma level of endothelin, catecholamines and salivary cortisol level before and after mental stress
Time Frame: 60 minutes
|
60 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Georg Noll, MD, University of Zurich
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK-1382
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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