Cardiovascular DiseaseNCT01007760
Dose-dependent Effects of Second-hand Smoke on Vascular Function
A study testing Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke in people with Cardiovascular Disease, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to determine the vascular effects of brief second-hand smoke exposure on normal healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jul 2011
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy non-smoking adults
Who cannot join
- Reported Active Smoking
- History of diabetes, hypertension, chronic respiratory disease, coronary artery disease, prior myocardial infarction or heart failure
- Pregnancy or breastfeeding
- Current use of prescription drugs within 14 days of trial
- Reported significant passive smoke exposure or elevated cotinine levels
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Dose-dependent Biological Mechanisms of Second-hand Smoke on Endothelial Function and Oxidative Stress
The purpose of this study is to determine the vascular effects of brief second-hand smoke exposure on normal healthy individuals.
Read the detailed description
Second-hand smoke remains a significant public health threat. Despite evidence to suggest that secondhand smoke contributes to adverse cardiovascular outcomes, little is known about the dose-dependent vascular effects of brief secondhand smoke exposure at low doses commonly encountered in the community. This study will investigate the acute vascular effects and dose-dependent biological mechanisms of secondhand smoke on endothelial function and oxidative stress.
- Conditions
- Cardiovascular Disease
- Being tested
- Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke
- Keywords
- Tobacco smoke, Oxidative stress, Endothelial Function, Atherosclerosis, Arterial Stiffness, Microvascular Function
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respirable suspended particles (RSP) PM 2.5 dose of second-hand smokeOther
acute one time exposure
| Study group | Role | What they receive |
|---|---|---|
| Room air | Placebo comparator | Not described Receives: Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke |
| Low dose exposure second-hand smoke | Active comparator | Not described Receives: Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke |
| High dose exposure second-hand smoke | Active comparator | Not described Receives: Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial Artery Flow-mediated dilation (FMD)
Measured: Same day - before/after exposure
Secondary outcomes (1)
Plasma measurement of asymmetric dimethylarginine (ADMA) and Nitrotyrosine levels
Measured: Same day - before/after exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Peter Ganz, MD, Principal investigator, UCSF San Francisco General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007760
- Sponsor's protocol ID
- TRDRP-18FT-0049
- Status last verified
- Jul 2011
- First submitted
- 3 Nov 2009
- Last updated
- 19 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-dependent Biological Mechanisms of Second-hand Smoke on Endothelial Function and Oxidative Stress
- ClinicalTrials.gov ID
- NCT01007760
- Acronym / sponsor ID
- TRDRP-18FT-0049
- Conditions
- Cardiovascular Disease
- Keywords
- Tobacco smoke, Oxidative stress, Endothelial Function, Atherosclerosis, Arterial Stiffness, Microvascular Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Nov 2009 (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 purpose of this study is to determine the vascular effects of brief second-hand smoke exposure on normal healthy individuals.
Detailed description
Second-hand smoke remains a significant public health threat. Despite evidence to suggest that secondhand smoke contributes to adverse cardiovascular outcomes, little is known about the dose-dependent vascular effects of brief secondhand smoke exposure at low doses commonly encountered in the community. This study will investigate the acute vascular effects and dose-dependent biological mechanisms of secondhand smoke on endothelial function and oxidative stress.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Room air | Placebo comparator | Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke |
| Low dose exposure second-hand smoke | Active comparator | Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke |
| High dose exposure second-hand smoke | Active comparator | Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy non-smoking adults
Key exclusion criteria (5 listed)
- Reported Active Smoking
- History of diabetes, hypertension, chronic respiratory disease, coronary artery disease, prior myocardial infarction or heart failure
- Pregnancy or breastfeeding
- Current use of prescription drugs within 14 days of trial
- Reported significant passive smoke exposure or elevated cotinine levels
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 |
|---|---|---|
| Respirable suspended particles (RSP) PM 2.5 dose of second-hand smokeacute one time exposure | Other | High dose exposure second-hand smoke, Low dose exposure second-hand smoke, Room air |
Primary outcome
Brachial Artery Flow-mediated dilation (FMD)
Time frame: Same day - before/after exposure
1 secondary outcome
Plasma measurement of asymmetric dimethylarginine (ADMA) and Nitrotyrosine levels
Time frame: Same day - before/after exposure
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 19 Jul 2011.
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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.
Peter Ganz, MD principal investigator
UCSF San Francisco General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke in people with Cardiovascular Disease, run by University of California, San Francisco at 1 site in United States.
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 1 inclusion and 5 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 19 Jul 2011. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Brachial Artery Flow-mediated dilation (FMD) (time frame: Same day - before/after exposure). 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 19 Jul 2011; AzTrials last refreshed its copy on 2 Nov 2026.