Sudden Cardiac DeathNCT03916341
Smoking and Ventricular Repolarization
A study testing EC with nicotine, EC without nicotine and TC with nicotine (own brand) in people with Sudden Cardiac Death and Prolonged QTc Interval, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sudden Cardiac Death, Prolonged QTc Interval
- What is being tested?
- EC with nicotine, EC without nicotine and TC with nicotine (own brand)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 10 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy non-smokers chronic TC smokers (non-e-cig users) Chronic EC smokers (Non-TC smokers)
Who cannot join
- Cardiac disease, respiratory disease, diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization.
Read the 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.
- Conditions
- Sudden Cardiac Death, Prolonged QTc Interval
- Being tested
- EC with nicotine, EC without nicotine, control, TC with nicotine (own brand), research TC with very low level nicotine
- Keywords
- e-cigarettes, tobacco cigarettes, nicotine, ventricular repolarization
- Medical subject headings
- Death, Sudden, Cardiac, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC with nicotineOther
Use an EC with nicotine for up to 30 minutes
EC without nicotineOther
Use an EC without nicotine for up to 30 minutes
controlOther
sham control
TC with nicotine (own brand)Other
smoke a TC
research TC with very low level nicotineOther
smoke a research TC with very low level nicotine
| Study group | Role | What they receive |
|---|---|---|
| Non-user | Experimental | 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) Receives: Other: EC with nicotine; Other: EC without nicotine; Other: control |
| Chronic EC user | Experimental | 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) Receives: Other: EC with nicotine; Other: EC without nicotine; Other: control |
| Chronic TC smoker | Experimental | 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) Receives: Other: control; Other: TC with nicotine (own brand); Other: research TC with very low level nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tpe
interval indicative of ventricular repolarization measured on ECG
Measured: Change in Tpe 5 minutes before and 5 minutes after cigarette use
Tpe/QT
ratio of intervals indicative of ventricular repolarization measured on ECG
Measured: 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
Measured: Change in Tpe/QTc 5 minutes before and 5 minutes after cigarette use
Secondary outcomes (2)
QT
interval indicative of ventricular repolarization measured on ECG
Measured: Change in QT 5 minutes before and 5 minutes after cigarette use
QTc
interval indicative of ventricular repolarization measured on ECG
Measured: Change in QTc 5 minutes before and 5 minutes after cigarette use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Oct 2019
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover with 4 week washout
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Responsible party
- Principal investigator, Holly R Middlekauff, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916341
- Sponsor's protocol ID
- 19-000452
- Status last verified
- Oct 2023
- First submitted
- 10 Apr 2019
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking and Ventricular Repolarization
- ClinicalTrials.gov ID
- NCT03916341
- Acronym / sponsor ID
- 19-000452
- Conditions
- Sudden Cardiac Death, Prolonged QTc Interval
- Keywords
- e-cigarettes, tobacco cigarettes, nicotine, ventricular repolarization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Crossover with 4 week washout
| Arm | Type | Receives |
|---|---|---|
| Non-user | Experimental | Other: EC with nicotine, Other: EC without nicotine, Other: controlNon- 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 | Experimental | Other: EC with nicotine, Other: EC without nicotine, Other: controlChronic 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 | Experimental | Other: control, Other: TC with nicotine (own brand), Other: research TC with very low level nicotineChronic 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) |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy non-smokers chronic TC smokers (non-e-cig users) Chronic EC smokers (Non-TC smokers)
Key exclusion criteria (1 listed)
- Cardiac disease, respiratory disease, diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EC with nicotineUse an EC with nicotine for up to 30 minutes | Other | Chronic EC user, Non-user |
| EC without nicotineUse an EC without nicotine for up to 30 minutes | Other | Chronic EC user, Non-user |
| controlsham control | Other | Chronic EC user, Chronic TC smoker, Non-user |
| TC with nicotine (own brand)smoke a TC | Other | Chronic TC smoker |
| research TC with very low level nicotinesmoke a research TC with very low level nicotine | Other | Chronic TC smoker |
Primary outcome
Tpe
Time frame: Change in Tpe 5 minutes before and 5 minutes after cigarette use
interval indicative of ventricular repolarization measured on ECG
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
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
2 secondary outcomes
QT
Time frame: Change in QT 5 minutes before and 5 minutes after cigarette use
QTc
Time frame: Change in QTc 5 minutes before and 5 minutes after cigarette use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EC with nicotine, EC without nicotine and TC with nicotine (own brand) in people with Sudden Cardiac Death and Prolonged QTc Interval, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tpe (time frame: Change in Tpe 5 minutes before and 5 minutes after cigarette use). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.