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Smoking and Ventricular Repolarization

Primary Purpose

Sudden Cardiac Death, Prolonged QTc Interval

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EC with nicotine
EC without nicotine
control
TC with nicotine (own brand)
research TC with very low level nicotine
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sudden Cardiac Death focused on measuring e-cigarettes, tobacco cigarettes, nicotine, ventricular repolarization

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy non-smokers chronic TC smokers (non-e-cig users) Chronic EC smokers (Non-TC smokers)

Exclusion Criteria:

  • Cardiac disease, respiratory disease, diabetes

Sites / Locations

  • UCaliforniaLA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Non-user

Chronic EC user

Chronic TC smoker

Arm Description

Non- users will use, in a randomized, crossover fashion with a 4 week washout, an 1) EC with nicotine, 2) EC without nicotine, and 3) an empty EC (control)

Chronic EC users will use, in a randomized, crossover fashion with a 4 week washout, an 1) EC with nicotine, 2) EC without nicotine, and 3) an empty EC (control)

Chronic TC smokers will use, in a randomized, crossover fashion with a 4 week washout, a 1) TC with nicotine (own brand), 2) research TC with very low level nicotine, and 3) a straw (control)

Outcomes

Primary Outcome Measures

Tpe
interval indicative of ventricular repolarization measured on ECG
Tpe/QT
ratio of intervals indicative of ventricular repolarization measured on ECG
Tpe/QTc
ratio of intervals indicative of ventricular repolarization measured on ECG

Secondary Outcome Measures

QT
interval indicative of ventricular repolarization measured on ECG
QTc
interval indicative of ventricular repolarization measured on ECG

Full Information

First Posted
April 10, 2019
Last Updated
October 2, 2023
Sponsor
University of California, Los Angeles
Collaborators
Tobacco Related Disease Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT03916341
Brief Title
Smoking and Ventricular Repolarization
Official Title
Smoking and Ventricular Repolarization
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
April 10, 2023 (Actual)
Study Completion Date
April 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Tobacco Related Disease Research Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization.
Detailed Description
Non-user or chronic electronic cigarette (EC) users will use an EC or control on three occasions:1) EC with nicotine, 2) EC without nicotine, 3) empty EC (control). Chronic tobacco cigarette (TC) smokers will use a TC or control on three occasions: 1) TC with nicotine (subject's own brand), 2) research TC with very low nicotine, 3) straw (control). The electrocardiogram will be recorded before and after acute exposures and analyzed for parameters representative of ventricular repolarization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Cardiac Death, Prolonged QTc Interval
Keywords
e-cigarettes, tobacco cigarettes, nicotine, ventricular repolarization

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover with 4 week washout
Masking
Outcomes Assessor
Masking Description
Single (outcomes assessor) code
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-user
Arm Type
Experimental
Arm Description
Non- users will use, in a randomized, crossover fashion with a 4 week washout, an 1) EC with nicotine, 2) EC without nicotine, and 3) an empty EC (control)
Arm Title
Chronic EC user
Arm Type
Experimental
Arm Description
Chronic EC users will use, in a randomized, crossover fashion with a 4 week washout, an 1) EC with nicotine, 2) EC without nicotine, and 3) an empty EC (control)
Arm Title
Chronic TC smoker
Arm Type
Experimental
Arm Description
Chronic TC smokers will use, in a randomized, crossover fashion with a 4 week washout, a 1) TC with nicotine (own brand), 2) research TC with very low level nicotine, and 3) a straw (control)
Intervention Type
Other
Intervention Name(s)
EC with nicotine
Intervention Description
Use an EC with nicotine for up to 30 minutes
Intervention Type
Other
Intervention Name(s)
EC without nicotine
Intervention Description
Use an EC without nicotine for up to 30 minutes
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
sham control
Intervention Type
Other
Intervention Name(s)
TC with nicotine (own brand)
Intervention Description
smoke a TC
Intervention Type
Other
Intervention Name(s)
research TC with very low level nicotine
Intervention Description
smoke a research TC with very low level nicotine
Primary Outcome Measure Information:
Title
Tpe
Description
interval indicative of ventricular repolarization measured on ECG
Time Frame
Change in Tpe 5 minutes before and 5 minutes after cigarette use
Title
Tpe/QT
Description
ratio of intervals indicative of ventricular repolarization measured on ECG
Time Frame
Change in Tpe/QT 5 minutes before and 5 minutes after cigarette use
Title
Tpe/QTc
Description
ratio of intervals indicative of ventricular repolarization measured on ECG
Time Frame
Change in Tpe/QTc 5 minutes before and 5 minutes after cigarette use
Secondary Outcome Measure Information:
Title
QT
Description
interval indicative of ventricular repolarization measured on ECG
Time Frame
Change in QT 5 minutes before and 5 minutes after cigarette use
Title
QTc
Description
interval indicative of ventricular repolarization measured on ECG
Time Frame
Change in QTc 5 minutes before and 5 minutes after cigarette use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy non-smokers chronic TC smokers (non-e-cig users) Chronic EC smokers (Non-TC smokers) Exclusion Criteria: Cardiac disease, respiratory disease, diabetes
Facility Information:
Facility Name
UCaliforniaLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Smoking and Ventricular Repolarization

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