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| Name | Class |
|---|---|
| Leeds Beckett University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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 |
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Inclusion Criteria:
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:
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Vapers conforming to specific group criteria in wider Sheffield and Leeds areas, in the U.K.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheffield Hallam University | Sheffield | S10 2BP | United Kingdom |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000072137 | Vaping |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| 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 |