Exploring the Long-term Cardiovascular Effects of Vaping

Cardiovascular Diseases Clinical Trial

— LIGER  

Official title:

Exploring the Long-term Cardiovascular Effects of Vaping: a Longitudinal Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757934
• Other study ID #: ER49341917
• Status: Recruiting
• Start date: April 16, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: November 2023
• Source: Sheffield Hallam University
• Contact: Markos Klonizakis, D.Phil.
• Phone: 01142255697
• Email: heartresearch[@]shu.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2026
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

Country	Name	City	State
United Kingdom	Sheffield Hallam University	Sheffield

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Hallam University	Leeds Beckett University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Brachial artery FMD using ultrasound	As in 24 months.	3 months
Secondary	Brachial artery FMD using ultrasound	As in 24 months.	6 months
Secondary	Brachial artery FMD using ultrasound	As in 24 months.	12 months
Secondary	Brachial artery FMD using ultrasound	As in 24 months.	18 months
Secondary	Vascular assessment of biomarkers	Venous blood samples (10 ml) will be obtained from the participants via a superficial arm vein to assess C-reactive protein, IL-12 (p70), sICAM-1, IL-8 and vWF.	24 months
Secondary	Vascular assessment of biomarkers	Venous blood samples (10 ml) will be obtained from the participants via a superficial arm vein to assess C-reactive protein, IL-12 (p70), sICAM-1, IL-8 and vWF.	12 months
Secondary	Vascular assessment of biomarkers	Venous blood samples (10 ml) will be obtained from the participants via a superficial arm vein to assess C-reactive protein, IL-12 (p70), sICAM-1, IL-8 and vWF.	6 months.
Secondary	Vascular assessment of biomarkers	Venous blood samples (10 ml) will be obtained from the participants via a superficial arm vein to assess C-reactive protein, IL-12 (p70), sICAM-1, IL-8 and vWF.	18 months
Secondary	Lung function	Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).	24 months
Secondary	Lung function	Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).	6 months
Secondary	Lung function	Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).	12 months
Secondary	Lung function	Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).	18 months
Secondary	Smoking dependence	Using Fagerström questionnaire.	baseline
Secondary	Vaping dependence	Using Vaping dependence questionnaire.	baseline
Secondary	Vaping dependence	Using Vaping dependence questionnaire.	6 months
Secondary	Vaping dependence	Using Vaping dependence questionnaire.	12 months
Secondary	Vaping dependence	Using Vaping dependence questionnaire.	18 months
Secondary	Vaping dependence	Using Vaping dependence questionnaire.	24 months
Secondary	Smoking dependence	Using Fagerström questionnaire.	24 months
Secondary	Smoking dependence	Using Fagerström questionnaire.	18 months
Secondary	Smoking dependence	Using Fagerström questionnaire.	12 months
Secondary	Smoking dependence	Using Fagerström questionnaire.	6 months
Secondary	Change in CV risk profile	Q-risk assessment	24 months
Secondary	Change in CV risk profile	Q-risk assessment	18 months
Secondary	Change in CV risk profile	Q-risk assessment	12 months
Secondary	Change in CV risk profile	Q-risk assessment	6 months
Secondary	Anthropometrics	height (m), weight (m) to calculate body mass index (BMI) as weight divided by height squared,	baseline
Secondary	Anthropometrics	height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,	24 months
Secondary	Anthropometrics	height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,	18 months
Secondary	Anthropometrics	height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,	12 months
Secondary	Anthropometrics	height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,	6 months
Secondary	Anthropometrics	heart rate variability (assessed as normal-to-normal (NN) intervals).	baseline
Secondary	Anthropometrics	blood pressure (mmHg).	baseline
Secondary	Anthropometrics	blood pressure (mmHg).	6 months
Secondary	Anthropometrics	blood pressure (mmHg).	12 months
Secondary	Anthropometrics	blood pressure (mmHg).	18 months
Secondary	Anthropometrics	blood pressure (mmHg).	24 months
Secondary	Anthropometrics	heart rate variability (assessed as normal-to-normal (NN) intervals).	24 months
Secondary	Anthropometrics	heart rate variability (assessed as normal-to-normal (NN) intervals).	18 months
Secondary	Anthropometrics	heart rate variability (assessed as normal-to-normal (NN) intervals).	12 months
Secondary	Anthropometrics	heart rate variability (assessed as normal-to-normal (NN) intervals).	6 months
Secondary	Smoking abstinence	For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm	24 months
Secondary	Smoking abstinence	For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm	18 months
Secondary	Smoking abstinence	For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm	12 months
Secondary	Smoking abstinence	For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm	6 months