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Arterial Inflammation and E-Cigarettes

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2016 by Holly R Middlekauff, University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Holly R Middlekauff, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02734888
First received: April 1, 2016
Last updated: April 5, 2016
Last verified: April 2016
  Purpose
Arterial inflammation will be compared using PET scanning in 3 groups: 1) Non-smokers, 2) Tobacco cigarette smokers, 3) Electronic cigarette users.

Condition Intervention
Arterial Inflammation Other: No drug or device, only a test. The test is called a PET/CT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Arterial Inflammation and E-Cigarettes

Resource links provided by NLM:


Further study details as provided by Holly R Middlekauff, University of California, Los Angeles:

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


Estimated Enrollment: 30
Study Start Date: July 2015
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Qualified participants will undergo a singe PET/CT to detect arterial inflammation.
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02734888

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

Locations
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
Principal Investigator: Holly R Middlekauff, MD University of California, Los Angeles
  More Information

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
Study First Received: April 1, 2016
Last Updated: April 5, 2016

Keywords provided by Holly R Middlekauff, University of California, Los Angeles:
arterial inflammation
electronic cigarettes
PET scan

Additional relevant MeSH terms:
Inflammation
Arteritis
Pathologic Processes
Vasculitis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 19, 2017