Prolonged QTc Interval, Sudden Cardiac Death
Conditions
Keywords
e-cigarettes, tobacco cigarettes, nicotine, 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.
Interventions
OTHEREC with nicotine
Use an EC with nicotine for up to 30 minutes
OTHEREC without nicotine
Use an EC without nicotine for up to 30 minutes
OTHERcontrol
sham control
OTHERTC with nicotine (own brand)
smoke a TC
OTHERresearch TC with very low level nicotine
smoke a research TC with very low level nicotine
Sponsors
Tobacco Related Disease Research Program
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
Single (outcomes assessor) code
Intervention model description
Crossover with 4 week washout
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tpe | Change in Tpe 5 minutes before and 5 minutes after cigarette use | interval indicative of ventricular repolarization measured on ECG |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed