Arterial Inflammation and E-Cigarettes

Sponsor

University of California, Los Angeles (Other)

Overall Status

Recruiting

CT.gov ID

NCT02734888

Collaborator

(none)

Enrollment

Location

Arms

91.1

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

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

Detailed Description

Qualified participants will undergo a singe PET/CT to detect arterial inflammation.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2015

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: 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
Other: 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
Other: 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

Arm

Intervention/Treatment

Other: 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

Other: 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

Other: 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

Primary Outcome Measures

target-to-background ratio (TBR) [intraoperative]
TBR will be detected on the scan

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	UCaliforniaLA	Los Angeles	California	United States	90095

Sponsors and Collaborators

University of California, Los Angeles

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Apr 12, 2016

Last Update Posted:

Mar 10, 2021

Last Verified:

Mar 1, 2021

Keywords provided by Holly R Middlekauff, Professor of Medicine, University of California, Los Angeles

arterial inflammation

electronic cigarettes

PET scan

Additional relevant MeSH terms:

Arteritis

Inflammation

Study Results

No Results Posted as of Mar 10, 2021