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Arterial Inflammation and E-Cigarettes

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ClinicalTrials.gov Identifier: NCT02734888
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Holly R Middlekauff, University of California, Los Angeles

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

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




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



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

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


Contacts
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Contact: Holly R Middlekauff, MD 310-206-6672 hmiddlekauff@mednet.ucla.edu
Contact: Kacey Peters, BS 310-825-3510 kpeters@mednet.ucla.edu

Locations
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United States, California
UCaliforniaLA Recruiting
Los Angeles, California, United States, 90095
Contact: Holly R Middlekauff, MD    310-206-6672    hmiddlekauff@mednet.ucla.edu   
Principal Investigator: Holly R Middlekauff, MD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Holly R Middlekauff, MD University of California, Los Angeles

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Responsible Party: Holly R Middlekauff, Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02734888     History of Changes
Other Study ID Numbers: 15-000552
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019

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