Mental StressNCT00538707
Effect of Mental Stress on Platelet Function
A study testing 2-minute Bondet test in people with Mental Stress, run by University of Zurich at 1 site in Switzerland.
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 Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Stress
- What is being tested?
- 2-minute Bondet test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects between 20 - 70 years of age
- written informed consent
- no evidence of diseases
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mental Stress on Platelet Function in Healthy Subjects
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
Read the 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.
- Conditions
- Mental Stress
- Being tested
- 2-minute Bondet test
- Keywords
- mental stress, platelet adhesion, platelet function, catecholamines
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-minute Bondet testBehavioural
Also called 2-minute Bondet light test
2-minute Bondet test
| Study group | Role | What they receive |
|---|---|---|
| Young subjects | Experimental | Not described Receives: Behavioral: 2-minute Bondet test |
| Older subjects | Experimental | Not described Receives: Behavioral: 2-minute Bondet test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of platelet function (shear stress dependent platelet adhesion and aggregation) before and after mental stress
Measured: 60 minutes
Secondary outcomes (1)
Evaluation of the plasma level of endothelin, catecholamines and salivary cortisol level before and after mental stress
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Georg Noll, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538707
- Sponsor's protocol ID
- EK-1382
- Status last verified
- Feb 2010
- First submitted
- 2 Oct 2007
- Last updated
- 10 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mental Stress on Platelet Function in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00538707
- Acronym / sponsor ID
- EK-1382
- Conditions
- Mental Stress
- Keywords
- mental stress, platelet adhesion, platelet function, catecholamines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young subjects | Experimental | Behavioral: 2-minute Bondet test |
| Older subjects | Experimental | Behavioral: 2-minute Bondet test |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy subjects between 20 - 70 years of age
- written informed consent
- no evidence of diseases
Key exclusion criteria (7 listed)
- pregnancy
- oral contraceptives
- smoking
- use of aspirin or NSAIDs within the last week
- use of benzodiazepines within the last week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-minute Bondet testAlso: 2-minute Bondet light test2-minute Bondet test | Behavioural | Older subjects, Young subjects |
Primary outcome
Evaluation of platelet function (shear stress dependent platelet adhesion and aggregation) before and after mental stress
Time frame: 60 minutes
1 secondary outcome
Evaluation of the plasma level of endothelin, catecholamines and salivary cortisol level before and after mental stress
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Noll, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-minute Bondet test in people with Mental Stress, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of platelet function (shear stress dependent platelet adhesion and aggregation) before and after mental stress (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2010.