NCT02734888

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

7.6 years

First QC Date

April 1, 2016

Last Update Submit

October 2, 2023

Conditions

Arterial Inflammation

Keywords

arterial inflammationelectronic cigarettesPET scan

Outcome Measures

Primary Outcomes (1)

  • target-to-background ratio (TBR)

    TBR will be detected on the scan

    intraoperative

Study Arms (3)

Healthy control

OTHER

Will undergo PET scan as a "negative control"

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

Tobacco cigarette smoker

OTHER

Will undergo PET scan as a "positive control"

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

E-cigarette user

OTHER

Will undergo PET scan

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

Interventions

No drug or device, only a test. The test is called a PET/CTOTHER

A single PET/CT scan will be performed

E-cigarette userHealthy controlTobacco cigarette smoker

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Cardiac disease
  • Respiratory Disease
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCaliforniaLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

ArteritisVaping

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesSmokingBehavior

Study Officials

  • Holly R Middlekauff, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 12, 2016

Study Start

July 1, 2015

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

October 4, 2023

Record last verified: 2023-10

Locations

US(1)