Exploring the Long-term Cardiovascular Effects of Vaping

N/AActive Not RecruitingNCT05757934

Sheffield Hallam University172 enrolled

Overview

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

Conditions

Cardiovascular Diseases

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Exploring the Long-term Cardiovascular Effects of Vaping

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes