Smoking and Ventricular Repolarization

Study Overview
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Brief Summary
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Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization.

Detailed Description
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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.

Official Title
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Smoking and Ventricular Repolarization

Conditions
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Sudden Cardiac Death, Prolonged QTc Interval

Intervention / Treatment
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* Other: EC with nicotine
* Other: EC without nicotine
* Other: control
* Other: TC with nicotine (own brand)
* Other: research TC with very low level nicotine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover with 4 week washout
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-user<br>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) | Other: EC with nicotine<br>* Use an EC with nicotine for up to 30 minutes<br>Other: EC without nicotine<br>* Use an EC without nicotine for up to 30 minutes<br>Other: control<br>* sham control<br>|
| Experimental: Chronic EC user<br>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) | Other: EC with nicotine<br>* Use an EC with nicotine for up to 30 minutes<br>Other: EC without nicotine<br>* Use an EC without nicotine for up to 30 minutes<br>Other: control<br>* sham control<br>|
| Experimental: Chronic TC smoker<br>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) | Other: control<br>* sham control<br>Other: TC with nicotine (own brand)<br>* smoke a TC<br>Other: research TC with very low level nicotine<br>* smoke a research TC with very low level nicotine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tpe | interval indicative of ventricular repolarization measured on ECG | Change in Tpe 5 minutes before and 5 minutes after cigarette use | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QT | interval indicative of ventricular repolarization measured on ECG | Change in QT 5 minutes before and 5 minutes after cigarette use | 
| QTc | interval indicative of ventricular repolarization measured on ECG | Change in QTc 5 minutes before and 5 minutes after cigarette use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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e-cigarettes, tobacco cigarettes, nicotine, ventricular repolarization