InflammationNCT02198937
Investigation on the Effect of Smoking on the Expression of Pro- and Anti-thrombotic, Anti-oxidative, and Inflammatory Markers in Humans
An observational study of Inflammation and Thrombosis, run by University of Zurich at 1 site in Switzerland.
Trial summary
Investigation on the effect of smoking on thrombus formation in humans. The expression of pro- and anti-thrombotic, anti-oxidative, and inflammatory markers will be assessed in 25-50 year old healthy smokers and non-smokers. The investigators are interested in possible differences between the two groups. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Thrombosis, Smoking
- What is being tested?
- Blood sample
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2014to Mar 2016
- Phase
- Observational
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Smokers and non-smokers
Who may be able to join
- Smoker
- Non-smokers
Who cannot join
- Disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Investigation on the effect of smoking on thrombus formation in humans. The expression of pro- and anti-thrombotic, anti-oxidative, and inflammatory markers will be assessed in 25-50 year old healthy smokers and non-smokers. The investigators are interested in possible differences between the two groups.
- Conditions
- Inflammation, Thrombosis, Smoking
- Being tested
- Blood sample
- Keywords
- smokers, non-smokers
- Medical subject headings
- Inflammation, Thrombosis, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Healthy smokers Receives: Other: Blood sample | |
| Non-Smokers | Healthy non-smokers Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of pro- and anti-thrombotic, anti-oxidative, and inflammatory markers in blood
Measured: Single time point, no follow-up (cross sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Funding unclear
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Staempfli, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198937
- Sponsor's protocol ID
- KEK-ZH-NR. 2014-0078
- Status last verified
- Oct 2016
- First submitted
- 21 Jul 2014
- Last updated
- 25 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Effect of Smoking on the Expression of Pro- and Anti-thrombotic, Anti-oxidative, and Inflammatory Markers in Humans
- ClinicalTrials.gov ID
- NCT02198937
- Acronym / sponsor ID
- KEK-ZH-NR. 2014-0078
- Conditions
- Inflammation, Thrombosis, Smoking
- Keywords
- smokers, non-smokers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding unclear
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 Jul 2014 (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.
Investigation on the effect of smoking on thrombus formation in humans. The expression of pro- and anti-thrombotic, anti-oxidative, and inflammatory markers will be assessed in 25-50 year old healthy smokers and non-smokers. The investigators are interested in possible differences between the two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smokers | – | Other: Blood sampleHealthy smokers |
| Non-Smokers | – | Other: Blood sampleHealthy non-smokers |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Smokers and non-smokers
Key inclusion criteria (2 listed)
- Smoker
- Non-smokers
Key exclusion criteria (2 listed)
- Disease
- Pregnancy
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 |
|---|---|---|
| Blood sample | Other | Non-Smokers, Smokers |
Primary outcome
Expression of pro- and anti-thrombotic, anti-oxidative, and inflammatory markers in blood
Time frame: Single time point, no follow-up (cross sectional)
Results and safety
The study was stopped early (reason given: Funding unclear). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Thrombosis, 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 25 Oct 2016. 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 was stopped early (reason given: Funding unclear). Results are not available in the source record.
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?
Expression of pro- and anti-thrombotic, anti-oxidative, and inflammatory markers in blood (time frame: Single time point, no follow-up (cross sectional)). 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 25 Oct 2016.