Clinical trial NCT05757934: Exploring the Long-term Cardiovascular Effects of Vaping
Official title: Exploring the Long-term Cardiovascular Effects of Vaping: a Longitudinal Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiovascular Diseases
Keywords: vaping
macrocirculation
smoking
blood biomarkers
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
Collaborators: name: Leeds Beckett University
First posted: 2023-03-07
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Vapers conforming to specific group criteria in wider Sheffield and Leeds areas, in the U.K.

Brief summary: Smoking is the "leading, preventable death-cause worldwide", being responsible for almost 700,000 deaths in the E.U. annually. Therefore, implementing successful, long-term smoking cessation strategies is a long-term priority for the NHS.

Recent evidence suggests that e-cigarettes (i.e., vaping) are a successful cessation tool, with around 3.6 million users in the UK. There are concerns about long-term vaping, particularly in relation to their cardiovascular effects, as there are no relevant, longitudinal studies.

Therefore, we propose a 38-month, four-group longitudinal study exploring the cardiovascular physiological effects of the use of e-cigarettes over a two-year period, informing policy makers and e-cigarette users (vapers). Our study was developed with the support of vapers.

The main research question is whether there are any differences in cardiovascular physiology between vapers, who are ex-smokers (Group A), vapers with no previous smoking experience (Group B), dual users (i.e., those who vape and smoke (Group C) and ex-smokers who don't vape (Group D).

Two-hundred participants from Sheffield and Leeds will be invited on five occasions (baseline, as well as 6-,12-,18- and 24-months post-baseline).

We will assess macrovascular and lung function, cardiovascular disease risk (through questionnaires and blood biomarkers), vaping and smoking dependence, smoking and and vaping history among others.


Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria: Age ≥18 years of either gender. Specific group inclusion criteria include:

Group A: Ex-smokers with previous smoking history of at least two years, who vape for at least one year, at least 50 puffs a day.

Group B: Current vapers who have been vaping daily (minimum 50 puffs/day) for at least one year, with no previous smoking history, Group C: Current vapers (50 puffs/day), who smoke at least 20 cigarettes per week. Group D: Ex-smokers, who have stopped smoking for a period greater than one year and who currently do not vape.

Exclusion Criteria:

* Non-ambulant people and people with a recent (e.g., within 6 months) CVD event (e.g. stroke, myocardial infarction) or cardiac surgery,
* pregnancy,
* people who require major surgery (which will prevent them of taking part in the study),
* people who are unable or unwilling to give informed consent.

Primary outcomes:
measure: Brachial artery FMD using ultrasound
timeFrame: 24 months
Secondary outcomes:
measure: Brachial artery FMD using ultrasound
timeFrame: 3 months
measure: Brachial artery FMD using ultrasound
timeFrame: 6 months
measure: Brachial artery FMD using ultrasound
timeFrame: 12 months
measure: Brachial artery FMD using ultrasound
timeFrame: 18 months
measure: Vascular assessment of biomarkers
timeFrame: 24 months
measure: Vascular assessment of biomarkers
timeFrame: 12 months
measure: Vascular assessment of biomarkers
timeFrame: 6 months.
measure: Vascular assessment of biomarkers
timeFrame: 18 months
measure: Lung function
timeFrame: 24 months
measure: Lung function
timeFrame: 6 months
measure: Lung function
timeFrame: 12 months
measure: Lung function
timeFrame: 18 months
measure: Smoking dependence
timeFrame: baseline
measure: Vaping dependence
timeFrame: baseline
measure: Vaping dependence
timeFrame: 6 months
measure: Vaping dependence
timeFrame: 12 months
measure: Vaping dependence
timeFrame: 18 months
measure: Vaping dependence
timeFrame: 24 months
measure: Smoking dependence
timeFrame: 24 months
measure: Smoking dependence
timeFrame: 18 months
measure: Smoking dependence
timeFrame: 12 months
measure: Smoking dependence
timeFrame: 6 months
measure: Change in CV risk profile
timeFrame: 24 months
measure: Change in CV risk profile
timeFrame: 18 months
measure: Change in CV risk profile
timeFrame: 12 months
measure: Change in CV risk profile
timeFrame: 6 months
measure: Anthropometrics
timeFrame: baseline
measure: Anthropometrics
timeFrame: 24 months
measure: Anthropometrics
timeFrame: 18 months
measure: Anthropometrics
timeFrame: 12 months
measure: Anthropometrics
timeFrame: 6 months
measure: Anthropometrics
timeFrame: baseline
measure: Anthropometrics
timeFrame: baseline
measure: Anthropometrics
timeFrame: 6 months
measure: Anthropometrics
timeFrame: 12 months
measure: Anthropometrics
timeFrame: 18 months
measure: Anthropometrics
timeFrame: 24 months
measure: Anthropometrics
timeFrame: 24 months
measure: Anthropometrics
timeFrame: 18 months
measure: Anthropometrics
timeFrame: 12 months
measure: Anthropometrics
timeFrame: 6 months
measure: Smoking abstinence
timeFrame: 24 months
measure: Smoking abstinence
timeFrame: 18 months
measure: Smoking abstinence
timeFrame: 12 months
measure: Smoking abstinence
timeFrame: 6 months
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Hallam University
Study officials:
References: