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NCT Number: NCT05757934

Exploring the Long-term Cardiovascular Effects of Vaping

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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Key information

Conditions

Cardiovascular Diseases Behavior Smoking Vaping

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheffield Hallam University

Sheffield, S10 2BP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Brachial artery FMD using ultrasound

    Time frame: 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 outcomes

  1. Brachial artery FMD using ultrasound

    Time frame: 3 months

    As in 24 months.

  2. Brachial artery FMD using ultrasound

    Time frame: 6 months

    As in 24 months.

  3. Brachial artery FMD using ultrasound

    Time frame: 12 months

    As in 24 months.

  4. Brachial artery FMD using ultrasound

    Time frame: 18 months

    As in 24 months.

  5. Vascular assessment of biomarkers

    Time frame: 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.

  6. Vascular assessment of biomarkers

    Time frame: 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.

  7. Vascular assessment of biomarkers

    Time frame: 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.

  8. Vascular assessment of biomarkers

    Time frame: 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.

  9. Lung function

    Time frame: 24 months

    Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).

  10. Lung function

    Time frame: 6 months

    Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).

  11. Lung function

    Time frame: 12 months

    Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).

  12. Lung function

    Time frame: 18 months

    Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).

  13. Smoking dependence

    Time frame: baseline

    Using Fagerström questionnaire.

  14. Vaping dependence

    Time frame: baseline

    Using Vaping dependence questionnaire.

  15. Vaping dependence

    Time frame: 6 months

    Using Vaping dependence questionnaire.

  16. Vaping dependence

    Time frame: 12 months

    Using Vaping dependence questionnaire.

  17. Vaping dependence

    Time frame: 18 months

    Using Vaping dependence questionnaire.

  18. Vaping dependence

    Time frame: 24 months

    Using Vaping dependence questionnaire.

  19. Smoking dependence

    Time frame: 24 months

    Using Fagerström questionnaire.

  20. Smoking dependence

    Time frame: 18 months

    Using Fagerström questionnaire.

  21. Smoking dependence

    Time frame: 12 months

    Using Fagerström questionnaire.

  22. Smoking dependence

    Time frame: 6 months

    Using Fagerström questionnaire.

  23. Change in CV risk profile

    Time frame: 24 months

    Q-risk assessment

  24. Change in CV risk profile

    Time frame: 18 months

    Q-risk assessment

  25. Change in CV risk profile

    Time frame: 12 months

    Q-risk assessment

  26. Change in CV risk profile

    Time frame: 6 months

    Q-risk assessment

  27. Anthropometrics

    Time frame: baseline

    height (m), weight (m) to calculate body mass index (BMI) as weight divided by height squared,

  28. Anthropometrics

    Time frame: 24 months

    height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,

  29. Anthropometrics

    Time frame: 18 months

    height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,

  30. Anthropometrics

    Time frame: 12 months

    height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,

  31. Anthropometrics

    Time frame: 6 months

    height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,

  32. Anthropometrics

    Time frame: baseline

    heart rate variability (assessed as normal-to-normal (NN) intervals).

  33. Anthropometrics

    Time frame: baseline

    blood pressure (mmHg).

  34. Anthropometrics

    Time frame: 6 months

    blood pressure (mmHg).

  35. Anthropometrics

    Time frame: 12 months

    blood pressure (mmHg).

  36. Anthropometrics

    Time frame: 18 months

    blood pressure (mmHg).

  37. Anthropometrics

    Time frame: 24 months

    blood pressure (mmHg).

  38. Anthropometrics

    Time frame: 24 months

    heart rate variability (assessed as normal-to-normal (NN) intervals).

  39. Anthropometrics

    Time frame: 18 months

    heart rate variability (assessed as normal-to-normal (NN) intervals).

  40. Anthropometrics

    Time frame: 12 months

    heart rate variability (assessed as normal-to-normal (NN) intervals).

  41. Anthropometrics

    Time frame: 6 months

    heart rate variability (assessed as normal-to-normal (NN) intervals).

  42. Smoking abstinence

    Time frame: 24 months

    For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm

  43. Smoking abstinence

    Time frame: 18 months

    For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm

  44. Smoking abstinence

    Time frame: 12 months

    For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm

  45. Smoking abstinence

    Time frame: 6 months

    For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm

Sponsors and collaborators

Lead sponsor

Sheffield Hallam University

Other

Collaborators

  • Leeds Beckett University

Registry information

Official study title

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

Acronym: LIGER

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2023
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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