Exploring the Long-term Cardiovascular Effects of Vaping: a Longitudinal Study (LIGER Study)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Brachial artery FMD using ultrasound [24 months]
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.
Secondary Outcome Measures
- Brachial artery FMD using ultrasound [3 months]
As in 24 months.
- Brachial artery FMD using ultrasound [6 months]
As in 24 months.
- Brachial artery FMD using ultrasound [12 months]
As in 24 months.
- Brachial artery FMD using ultrasound [18 months]
As in 24 months.
- Vascular assessment of biomarkers [24 months]
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.
- Vascular assessment of biomarkers [12 months]
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.
- Vascular assessment of biomarkers [6 months.]
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.
- Vascular assessment of biomarkers [18 months]
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.
- Lung function [24 months]
Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).
- Lung function [6 months]
Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).
- Lung function [12 months]
Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).
- Lung function [18 months]
Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).
- Smoking dependence [baseline]
Using Fagerström questionnaire.
- Vaping dependence [baseline]
Using Vaping dependence questionnaire.
- Vaping dependence [6 months]
Using Vaping dependence questionnaire.
- Vaping dependence [12 months]
Using Vaping dependence questionnaire.
- Vaping dependence [18 months]
Using Vaping dependence questionnaire.
- Vaping dependence [24 months]
Using Vaping dependence questionnaire.
- Smoking dependence [24 months]
Using Fagerström questionnaire.
- Smoking dependence [18 months]
Using Fagerström questionnaire.
- Smoking dependence [12 months]
Using Fagerström questionnaire.
- Smoking dependence [6 months]
Using Fagerström questionnaire.
- Change in CV risk profile [24 months]
Q-risk assessment
- Change in CV risk profile [18 months]
Q-risk assessment
- Change in CV risk profile [12 months]
Q-risk assessment
- Change in CV risk profile [6 months]
Q-risk assessment
- Anthropometrics [baseline]
height (m), weight (m) to calculate body mass index (BMI) as weight divided by height squared,
- Anthropometrics [24 months]
height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,
- Anthropometrics [18 months]
height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,
- Anthropometrics [12 months]
height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,
- Anthropometrics [6 months]
height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,
- Anthropometrics [baseline]
heart rate variability (assessed as normal-to-normal (NN) intervals).
- Anthropometrics [baseline]
blood pressure (mmHg).
- Anthropometrics [6 months]
blood pressure (mmHg).
- Anthropometrics [12 months]
blood pressure (mmHg).
- Anthropometrics [18 months]
blood pressure (mmHg).
- Anthropometrics [24 months]
blood pressure (mmHg).
- Anthropometrics [24 months]
heart rate variability (assessed as normal-to-normal (NN) intervals).
- Anthropometrics [18 months]
heart rate variability (assessed as normal-to-normal (NN) intervals).
- Anthropometrics [12 months]
heart rate variability (assessed as normal-to-normal (NN) intervals).
- Anthropometrics [6 months]
heart rate variability (assessed as normal-to-normal (NN) intervals).
- Smoking abstinence [24 months]
For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm
- Smoking abstinence [18 months]
For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm
- Smoking abstinence [12 months]
For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm
- Smoking abstinence [6 months]
For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm
Eligibility Criteria
Criteria
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:
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Non-ambulant people and people with a recent (e.g., within 6 months) CVD event (e.g. stroke, myocardial infarction) or cardiac surgery,
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pregnancy,
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people who require major surgery (which will prevent them of taking part in the study),
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people who are unable or unwilling to give informed consent.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sheffield Hallam University
- Leeds Beckett University
- King's College London
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ER49341917