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Arterial Inflammation and E-Cigarettes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02734888
Recruitment Status : Active, not recruiting
First Posted : April 12, 2016
Last Update Posted : September 10, 2022
Sponsor:
Information provided by (Responsible Party):
Holly R Middlekauff, University of California, Los Angeles

Study Description
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Brief Summary:
Arterial inflammation will be compared using PET scanning in 3 groups: 1) Non-smokers, 2) Tobacco cigarette smokers, 3) Electronic cigarette users.

Condition or disease Intervention/treatment Phase
Arterial Inflammation Other: No drug or device, only a test. The test is called a PET/CT Not Applicable

Detailed Description:
Qualified participants will undergo a singe PET/CT to detect arterial inflammation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Arterial Inflammation and E-Cigarettes
Study Start Date : July 2015
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arms and Interventions
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Arm Intervention/treatment
Healthy control
Will undergo PET scan as a "negative control"
 Other: No drug or device, only a test. The test is called a PET/CT
A single PET/CT scan will be performed
Tobacco cigarette smoker
Will undergo PET scan as a "positive control"
 Other: No drug or device, only a test. The test is called a PET/CT
A single PET/CT scan will be performed
E-cigarette user
Will undergo PET scan
 Other: No drug or device, only a test. The test is called a PET/CT
A single PET/CT scan will be performed


Outcome Measures
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Primary Outcome Measures :
  1. target-to-background ratio (TBR) [ Time Frame: intraoperative ]
    TBR will be detected on the scan


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy

  • Nonsmokers OR
  • Daily e-cigarette user OR
  • Daily tobacco cigarette smoker

Exclusion Criteria:

  • Cardiac disease
  • Respiratory Disease
  • Diabetes mellitus
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734888


Locations
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United States, California
UCaliforniaLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Holly R Middlekauff, MD University of California, Los Angeles
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Holly R Middlekauff, Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02734888    
Other Study ID Numbers: 15-000552
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: September 10, 2022
Last Verified: September 2022
Keywords provided by Holly R Middlekauff, University of California, Los Angeles:
arterial inflammation
electronic cigarettes
PET scan
Additional relevant MeSH terms:
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Arteritis
Inflammation
Pathologic Processes
 Vasculitis
Vascular Diseases
Cardiovascular Diseases