Smoking and Ventricular Repolarization

Not Applicable

Completed

• Conditions: Sudden Cardiac Death; Prolonged QTc Interval
• Interventions: Other: EC with nicotine; Other: EC without nicotine; Other: TC with nicotine (own brand); Other: research TC with very low level nicotine; Other: control

• Registration Number: NCT03916341
• Lead Sponsor: University of California, Los Angeles

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 Timeline

• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-16
• Study Start: 2019-10-01
• Primary Completion: 2023-04-10
• Study Completion: 2023-04-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

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Exclusion Criteria

• Cardiac disease, respiratory disease, diabetes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Chronic TC smoker	research TC with very low level nicotine	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)
Non-user	control	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 TC smoker	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)
Non-user	EC with nicotine	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)
Non-user	EC without nicotine	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 user	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 EC user	EC with nicotine	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 EC user	EC without nicotine	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 smoker	TC with nicotine (own brand)	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)

Primary Outcome Measures

Name	Time	Method
Tpe/QT	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	Change in Tpe/QTc 5 minutes before and 5 minutes after cigarette use	ratio of intervals indicative of ventricular repolarization measured on ECG
Tpe	Change in Tpe 5 minutes before and 5 minutes after cigarette use	interval indicative of ventricular repolarization measured on ECG

Secondary Outcome Measures

Name	Time	Method
QT	Change in QT 5 minutes before and 5 minutes after cigarette use	interval indicative of ventricular repolarization measured on ECG
QTc	Change in QTc 5 minutes before and 5 minutes after cigarette use	interval indicative of ventricular repolarization measured on ECG

Trial Locations

Locations (1)

UCaliforniaLA; 🇺🇸 Los Angeles, California, United States