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Smoking and Ventricular Repolarization

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ClinicalTrials.gov Identifier: NCT03916341
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Tobacco Related Disease Research Program
Information provided by (Responsible Party):
Holly R Middlekauff, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE April 10, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date July 11, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date April 10, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • Tpe [ Time Frame: Change in Tpe 5 minutes before and 5 minutes after cigarette use ]
    interval indicative of ventricular repolarization measured on ECG
  • Tpe/QT [ Time Frame: Change in Tpe/QT 5 minutes before and 5 minutes after cigarette use ]
    ratio of intervals indicative of ventricular repolarization measured on ECG
  • Tpe/QTc [ Time Frame: Change in Tpe/QTc 5 minutes before and 5 minutes after cigarette use ]
    ratio of intervals indicative of ventricular repolarization measured on ECG
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03916341 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • QT [ Time Frame: Change in QT 5 minutes before and 5 minutes after cigarette use ]
    interval indicative of ventricular repolarization measured on ECG
  • QTc [ Time Frame: Change in QTc 5 minutes before and 5 minutes after cigarette use ]
    interval indicative of ventricular repolarization measured on ECG
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smoking and Ventricular Repolarization
Official Title  ICMJE Smoking and Ventricular Repolarization
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Crossover with 4 week washout
Masking: Single (Outcomes Assessor)
Masking Description:
Single (outcomes assessor) code
Primary Purpose: Basic Science
Condition  ICMJE
  • Sudden Cardiac Death
  • Prolonged QTc Interval
Intervention  ICMJE
  • Other: EC with nicotine
    Use an EC with nicotine for up to 30 minutes
  • Other: EC without nicotine
    Use an EC without nicotine for up to 30 minutes
  • Other: control
    sham control
  • Other: TC with nicotine (own brand)
    smoke a TC
  • Other: research TC with very low level nicotine
    smoke a research TC with very low level nicotine
Study Arms  ICMJE
  • Experimental: Non-user
    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)
    Interventions:
    • Other: EC with nicotine
    • Other: EC without nicotine
    • Other: control
  • Experimental: Chronic EC user
    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)
    Interventions:
    • Other: EC with nicotine
    • Other: EC without nicotine
    • Other: control
  • Experimental: Chronic TC smoker
    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)
    Interventions:
    • Other: control
    • Other: TC with nicotine (own brand)
    • Other: research TC with very low level nicotine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2019)
145
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 10, 2024
Estimated Primary Completion Date April 10, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Holly R Middlekauff, MD 310-206-6672 hmiddlekauff@mednet.ucla.edu
Contact: Karishma Lakhani, BS 310-825-3510 klakhani@mednet.ucla.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03916341
Other Study ID Numbers  ICMJE 19-000452
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Holly R Middlekauff, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Tobacco Related Disease Research Program
Investigators  ICMJE Not Provided
PRS Account University of California, Los Angeles
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP