Exploring the Long-term Cardiovascular Effects of Vaping

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Diseases

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>vapers, who are ex-smokers. | |
| Group B<br>vapers with no previous smoking experience. | |
| Group C<br>vapers, who are dual users (i.e., those who vape and smoke). | |
| Group D<br>ex-smokers who don't vape. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial artery FMD using ultrasound | As in 24 months. | 3 months | 
| Brachial artery FMD using ultrasound | As in 24 months. | 6 months | 
| Brachial artery FMD using ultrasound | As in 24 months. | 12 months | 
| Brachial artery FMD using ultrasound | As in 24 months. | 18 months | 
| 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 | 
| 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 | 
| 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. | 
| 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 | 
| Lung function | Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines). | 24 months | 
| Lung function | Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines). | 6 months | 
| Lung function | Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines). | 12 months | 
| Lung function | Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines). | 18 months | 
| Smoking dependence | Using Fagerström questionnaire. | baseline | 
| Vaping dependence | Using Vaping dependence questionnaire. | baseline | 
| Vaping dependence | Using Vaping dependence questionnaire. | 6 months | 
| Vaping dependence | Using Vaping dependence questionnaire. | 12 months | 
| Vaping dependence | Using Vaping dependence questionnaire. | 18 months | 
| Vaping dependence | Using Vaping dependence questionnaire. | 24 months | 
| Smoking dependence | Using Fagerström questionnaire. | 24 months | 
| Smoking dependence | Using Fagerström questionnaire. | 18 months | 
| Smoking dependence | Using Fagerström questionnaire. | 12 months | 
| Smoking dependence | Using Fagerström questionnaire. | 6 months | 
| Change in CV risk profile | Q-risk assessment | 24 months | 
| Change in CV risk profile | Q-risk assessment | 18 months | 
| Change in CV risk profile | Q-risk assessment | 12 months | 
| Change in CV risk profile | Q-risk assessment | 6 months | 
| Anthropometrics | height (m), weight (m) to calculate body mass index (BMI) as weight divided by height squared, | baseline | 
| Anthropometrics | height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared, | 24 months | 
| Anthropometrics | height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared, | 18 months | 
| Anthropometrics | height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared, | 12 months | 
| Anthropometrics | height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared, | 6 months | 
| Anthropometrics | heart rate variability (assessed as normal-to-normal (NN) intervals). | baseline | 
| Anthropometrics | blood pressure (mmHg). | baseline | 
| Anthropometrics | blood pressure (mmHg). | 6 months | 
| Anthropometrics | blood pressure (mmHg). | 12 months | 
| Anthropometrics | blood pressure (mmHg). | 18 months | 
| Anthropometrics | blood pressure (mmHg). | 24 months | 
| Anthropometrics | heart rate variability (assessed as normal-to-normal (NN) intervals). | 24 months | 
| Anthropometrics | heart rate variability (assessed as normal-to-normal (NN) intervals). | 18 months | 
| Anthropometrics | heart rate variability (assessed as normal-to-normal (NN) intervals). | 12 months | 
| Anthropometrics | heart rate variability (assessed as normal-to-normal (NN) intervals). | 6 months | 
| Smoking abstinence | For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm | 24 months | 
| Smoking abstinence | For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm | 18 months | 
| Smoking abstinence | For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm | 12 months | 
| Smoking abstinence | For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaping, macrocirculation, smoking, blood biomarkers