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.
Study Type
OBSERVATIONAL
Enrollment
172
Sheffield Hallam University
Sheffield, United Kingdom
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.
Time frame: 24 months
Brachial artery FMD using ultrasound
As in 24 months.
Time frame: 3 months
Brachial artery FMD using ultrasound
As in 24 months.
Time frame: 6 months
Brachial artery FMD using ultrasound
As in 24 months.
Time frame: 12 months
Brachial artery FMD using ultrasound
As in 24 months.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 18 months
Lung function
Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).
Time frame: 24 months
Lung function
Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).
Time frame: 6 months
Lung function
Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).
Time frame: 12 months
Lung function
Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).
Time frame: 18 months
Smoking dependence
Using Fagerström questionnaire.
Time frame: baseline
Vaping dependence
Using Vaping dependence questionnaire.
Time frame: baseline
Vaping dependence
Using Vaping dependence questionnaire.
Time frame: 6 months
Vaping dependence
Using Vaping dependence questionnaire.
Time frame: 12 months
Vaping dependence
Using Vaping dependence questionnaire.
Time frame: 18 months
Vaping dependence
Using Vaping dependence questionnaire.
Time frame: 24 months
Smoking dependence
Using Fagerström questionnaire.
Time frame: 24 months
Smoking dependence
Using Fagerström questionnaire.
Time frame: 18 months
Smoking dependence
Using Fagerström questionnaire.
Time frame: 12 months
Smoking dependence
Using Fagerström questionnaire.
Time frame: 6 months
Change in CV risk profile
Q-risk assessment
Time frame: 24 months
Change in CV risk profile
Q-risk assessment
Time frame: 18 months
Change in CV risk profile
Q-risk assessment
Time frame: 12 months
Change in CV risk profile
Q-risk assessment
Time frame: 6 months
Anthropometrics
height (m), weight (m) to calculate body mass index (BMI) as weight divided by height squared,
Time frame: baseline
Anthropometrics
height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,
Time frame: 24 months
Anthropometrics
height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,
Time frame: 18 months
Anthropometrics
height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,
Time frame: 12 months
Anthropometrics
height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,
Time frame: 6 months
Anthropometrics
heart rate variability (assessed as normal-to-normal (NN) intervals).
Time frame: baseline
Anthropometrics
blood pressure (mmHg).
Time frame: baseline
Anthropometrics
blood pressure (mmHg).
Time frame: 6 months
Anthropometrics
blood pressure (mmHg).
Time frame: 12 months
Anthropometrics
blood pressure (mmHg).
Time frame: 18 months
Anthropometrics
blood pressure (mmHg).
Time frame: 24 months
Anthropometrics
heart rate variability (assessed as normal-to-normal (NN) intervals).
Time frame: 24 months
Anthropometrics
heart rate variability (assessed as normal-to-normal (NN) intervals).
Time frame: 18 months
Anthropometrics
heart rate variability (assessed as normal-to-normal (NN) intervals).
Time frame: 12 months
Anthropometrics
heart rate variability (assessed as normal-to-normal (NN) intervals).
Time frame: 6 months
Smoking abstinence
For Groups A, B and D smoking abstinence will be defined by the presence of CO \< 10ppm
Time frame: 24 months
Smoking abstinence
For Groups A, B and D smoking abstinence will be defined by the presence of CO \< 10ppm
Time frame: 18 months
Smoking abstinence
For Groups A, B and D smoking abstinence will be defined by the presence of CO \< 10ppm
Time frame: 12 months
Smoking abstinence
For Groups A, B and D smoking abstinence will be defined by the presence of CO \< 10ppm
Time frame: 6 months
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