Exploring the Long-term Cardiovascular Effects of Vaping

NCT05757934 | Active Not Recruiting

• 1 other identifier: ER49341917
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

vaping; macrocirculation; smoking; blood biomarkers

Outcome Measures

Primary Outcomes (1)

• Brachial artery FMD using ultrasound

  Baseline scanning to assess resting vessel diameter will be recorded over 3 min, following a 10-min resting period. The brachial artery will be imaged at a location 3 to 7 cm above the antecubital crease to create a flow stimulus in the brachial artery. The images will be obtained with a Viamo C100 (Canon Medical Systems Europe B.V., Zoetermeer, Netherlands) unit using a 7.5MHz PSI-30BX (Canon Medical Systems Europe B.V., Zoetermeer, Netherlands) transducer. A sphygmomanometric cuff will be placed on the forearm; the cuff will be inflated at least 50 mmHg above systolic pressure to occlude artery inflow for 5 min. Recordings will commence 30s before cuff deflation and continuing for 3 min after. FMD will be expressed as a change in post-stimulus diameter evaluated as a percentage of the baseline diameter.

  24 months

Secondary Outcomes (45)

• Brachial artery FMD using ultrasound

  3 months

• Brachial artery FMD using ultrasound

  6 months

• Brachial artery FMD using ultrasound

  12 months

• Brachial artery FMD using ultrasound

  18 months

• Vascular assessment of biomarkers

  24 months

Study Arms (4)

Group A

vapers, who are ex-smokers.

Group B

vapers with no previous smoking experience.

Group C

vapers, who are dual users (i.e., those who vape and smoke).

Group D

ex-smokers who don't vape.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Vapers conforming to specific group criteria in wider Sheffield and Leeds areas, in the U.K.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Hallam University: lead
• Leeds Beckett University: collaborator

Study Sites (1)

Sheffield Hallam University

Sheffield, S10 2BP, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Vaping; Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Vascular and Clinical Physiology

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 7, 2023
• Study Start: April 16, 2023
• Primary Completion: January 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

GB (1)