Arterial InflammationNCT02734888
Arterial Inflammation and E-Cigarettes
A study testing No drug or device, only a test. The test is called a PET/CT in people with Arterial Inflammation, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Arterial inflammation will be compared using PET scanning in 3 groups: 1) Non-smokers, 2) Tobacco cigarette smokers, 3) Electronic cigarette users. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Inflammation
- What is being tested?
- No drug or device, only a test. The test is called a PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 1 Feb 2023
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Nonsmokers OR
- Daily e-cigarette user OR
- Daily tobacco cigarette smoker
Who cannot join
- Cardiac disease
- Respiratory Disease
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Arterial inflammation will be compared using PET scanning in 3 groups: 1) Non-smokers, 2) Tobacco cigarette smokers, 3) Electronic cigarette users.
Read the detailed description
Qualified participants will undergo a singe PET/CT to detect arterial inflammation.
- Conditions
- Arterial Inflammation
- Being tested
- No drug or device, only a test. The test is called a PET/CT
- Keywords
- arterial inflammation, electronic cigarettes, PET scan
- Medical subject headings
- Arteritis, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No drug or device, only a test. The test is called a PET/CTOther
A single PET/CT scan will be performed
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | Other | Will undergo PET scan as a "negative control" Receives: Other: No drug or device, only a test. The test is called a PET/CT |
| Tobacco cigarette smoker | Other | Will undergo PET scan as a "positive control" Receives: Other: No drug or device, only a test. The test is called a PET/CT |
| E-cigarette user | Other | Will undergo PET scan Receives: Other: No drug or device, only a test. The test is called a PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
target-to-background ratio (TBR)
TBR will be detected on the scan
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startJul 2015
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial InflammationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holly R Middlekauff, University of California, Los Angeles
- Investigators
- Holly R Middlekauff, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734888
- Sponsor's protocol ID
- 15-000552
- Status last verified
- Oct 2023
- First submitted
- 1 Apr 2016
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Inflammation and E-Cigarettes
- ClinicalTrials.gov ID
- NCT02734888
- Acronym / sponsor ID
- 15-000552
- Conditions
- Arterial Inflammation
- Keywords
- arterial inflammation, electronic cigarettes, PET scan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 12 Apr 2016 (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.
Arterial inflammation will be compared using PET scanning in 3 groups: 1) Non-smokers, 2) Tobacco cigarette smokers, 3) Electronic cigarette users.
Detailed description
Qualified participants will undergo a singe PET/CT to detect arterial inflammation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control | Other | Other: No drug or device, only a test. The test is called a PET/CTWill undergo PET scan as a "negative control" |
| Tobacco cigarette smoker | Other | Other: No drug or device, only a test. The test is called a PET/CTWill undergo PET scan as a "positive control" |
| E-cigarette user | Other | Other: No drug or device, only a test. The test is called a PET/CTWill undergo PET scan |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Nonsmokers OR
- Daily e-cigarette user OR
- Daily tobacco cigarette smoker
Key exclusion criteria (3 listed)
- Cardiac disease
- Respiratory Disease
- Diabetes mellitus
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 |
|---|---|---|
| No drug or device, only a test. The test is called a PET/CTA single PET/CT scan will be performed | Other | E-cigarette user, Healthy control, Tobacco cigarette smoker |
Primary outcome
target-to-background ratio (TBR)
Time frame: intraoperative
TBR will be detected on the scan
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 4 Oct 2023.
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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.
Holly R Middlekauff, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No drug or device, only a test. The test is called a PET/CT in people with Arterial Inflammation, run by University of California, Los Angeles 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 4 inclusion and 3 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 4 Oct 2023. 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. 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?
target-to-background ratio (TBR) (time frame: intraoperative). 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 4 Oct 2023.