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NCT03916341 Clinical Trial

Smoking and Ventricular Repolarization

Sudden Cardiac Death Clinical Trial

Official title:
Smoking and Ventricular Repolarization

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03916341
Other study ID # 19-000452
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date April 10, 2023

Study information
Verified date October 2023
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date April 10, 2023
Est. primary completion date April 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• EC with nicotine
Use an EC with nicotine for up to 30 minutes
• EC without nicotine
Use an EC without nicotine for up to 30 minutes
• control
sham control
• TC with nicotine (own brand)
smoke a TC
• research TC with very low level nicotine
smoke a research TC with very low level nicotine

Locations
Country Name City State
United States UCaliforniaLA Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
University of California, Los Angeles Tobacco Related Disease Research Program

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tpe interval indicative of ventricular repolarization measured on ECG Change in Tpe 5 minutes before and 5 minutes after cigarette use
Primary Tpe/QT ratio of intervals indicative of ventricular repolarization measured on ECG Change in Tpe/QT 5 minutes before and 5 minutes after cigarette use
Primary Tpe/QTc ratio of intervals indicative of ventricular repolarization measured on ECG Change in Tpe/QTc 5 minutes before and 5 minutes after cigarette use
Secondary QT interval indicative of ventricular repolarization measured on ECG Change in QT 5 minutes before and 5 minutes after cigarette use
Secondary QTc interval indicative of ventricular repolarization measured on ECG Change in QTc 5 minutes before and 5 minutes after cigarette use
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