- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02734888
Arterial Inflammation and E-Cigarettes
October 2, 2023 updated by: Holly R Middlekauff, University of California, Los Angeles
Arterial inflammation will be compared using PET scanning in 3 groups: 1) Non-smokers, 2) Tobacco cigarette smokers, 3) Electronic cigarette users.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Qualified participants will undergo a singe PET/CT to detect arterial inflammation.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCaliforniaLA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Healthy
- Nonsmokers OR
- Daily e-cigarette user OR
- Daily tobacco cigarette smoker
Exclusion Criteria:
- Cardiac disease
- Respiratory Disease
- Diabetes mellitus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Healthy control
Will undergo PET scan as a "negative control"
|
A single PET/CT scan will be performed
|
|
Other: Tobacco cigarette smoker
Will undergo PET scan as a "positive control"
|
A single PET/CT scan will be performed
|
|
Other: E-cigarette user
Will undergo PET scan
|
A single PET/CT scan will be performed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
target-to-background ratio (TBR)
Time Frame: intraoperative
|
TBR will be detected on the scan
|
intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Holly R Middlekauff, MD, University of California, Los Angeles
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
February 1, 2023
Study Completion (Actual)
February 1, 2023
Study Registration Dates
First Submitted
April 1, 2016
First Submitted That Met QC Criteria
April 5, 2016
First Posted (Estimated)
April 12, 2016
Study Record Updates
Last Update Posted (Actual)
October 4, 2023
Last Update Submitted That Met QC Criteria
October 2, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-000552
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.