Back to resultsArterial Inflammation and E-Cigarettes
Primary Purpose
Arterial Inflammation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No drug or device, only a test. The test is called a PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Arterial Inflammation focused on measuring arterial inflammation, electronic cigarettes, PET scan
Eligibility Criteria
Inclusion Criteria:
Healthy
- Nonsmokers OR
- Daily e-cigarette user OR
- Daily tobacco cigarette smoker
Exclusion Criteria:
- Cardiac disease
- Respiratory Disease
- Diabetes mellitus
Sites / Locations
- UCaliforniaLA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Healthy control
Tobacco cigarette smoker
E-cigarette user
Arm Description
Will undergo PET scan as a "negative control"
Will undergo PET scan as a "positive control"
Will undergo PET scan
Outcomes
Primary Outcome Measures
target-to-background ratio (TBR)
TBR will be detected on the scan
Secondary Outcome Measures
Full Information
NCT ID
NCT02734888
First Posted
April 1, 2016
Last Updated
October 2, 2023
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02734888
Brief Title
Arterial Inflammation and E-Cigarettes
Official Title
Arterial Inflammation and E-Cigarettes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Inflammation
Keywords
arterial inflammation, electronic cigarettes, PET scan
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy control
Arm Type
Other
Arm Description
Will undergo PET scan as a "negative control"
Arm Title
Tobacco cigarette smoker
Arm Type
Other
Arm Description
Will undergo PET scan as a "positive control"
Arm Title
E-cigarette user
Arm Type
Other
Arm Description
Will undergo PET scan
Intervention Type
Other
Intervention Name(s)
No drug or device, only a test. The test is called a PET/CT
Intervention Description
A single PET/CT scan will be performed
Primary Outcome Measure Information:
Title
target-to-background ratio (TBR)
Description
TBR will be detected on the scan
Time Frame
intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy
Nonsmokers OR
Daily e-cigarette user OR
Daily tobacco cigarette smoker
Exclusion Criteria:
Cardiac disease
Respiratory Disease
Diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly R Middlekauff, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCaliforniaLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Arterial Inflammation and E-Cigarettes
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