Effect of Mental Stress on Platelet Function

Mental Stress Clinical Trial

Official title:

Effect of Mental Stress on Platelet Function in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538707
• Other study ID #: EK-1382
• Status: Completed
• Phase: N/A
• First received: October 2, 2007
• Last updated: February 9, 2010
• Start date: September 2007
• Est. completion date: December 2009

Study information

• Verified date: February 2010
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mental Stress
• Stress, Psychological

Intervention

Behavioral:
• 2-minute Bondet test
2-minute Bondet test

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of platelet function (shear stress dependent platelet adhesion and aggregation) before and after mental stress		60 minutes	No
Secondary	Evaluation of the plasma level of endothelin, catecholamines and salivary cortisol level before and after mental stress		60 minutes	No