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OpenTrials
Completed

NCT Number: NCT03916341

Smoking and Ventricular Repolarization

Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization.

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Key information

Conditions

Sudden Cardiac Death Behavior Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Prolonged QTc Interval Smoking Vaping

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCaliforniaLA

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EC with nicotine

Other

Use an EC with nicotine for up to 30 minutes

EC without nicotine

Other

Use an EC without nicotine for up to 30 minutes

Control

Other

sham control

TC with nicotine (own brand)

Other

smoke a TC

research TC with very low level nicotine

Other

smoke a research TC with very low level nicotine

Primary outcomes

  1. Tpe

    Time frame: Change in Tpe 5 minutes before and 5 minutes after cigarette use

    interval indicative of ventricular repolarization measured on ECG

  2. 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

  3. 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

Secondary outcomes

  1. QT

    Time frame: Change in QT 5 minutes before and 5 minutes after cigarette use

    interval indicative of ventricular repolarization measured on ECG

  2. QTc

    Time frame: Change in QTc 5 minutes before and 5 minutes after cigarette use

    interval indicative of ventricular repolarization measured on ECG

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Tobacco Related Disease Research Program

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 16, 2019
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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