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| Name | Class |
|---|---|
| NHS Tayside | OTHER_GOV |
| British Heart Foundation | OTHER |
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The purpose of this study is to assess the effects of electronic cigarettes-nicotine and electronic cigarette-nicotine free on endothelial function as compared to traditional cigarettes. Due to ethical reasons, we cannot fully randomise all particpants to the three arms.
Participants who wish to quit smoking will be randomized to
Electronic cigarettes (EC) are gaining popularity as an alternative to Traditional Cigarettes (TC). Despite not containing all the harmful substances seen in TC, EC are known to contain impurities that may have a detrimental impact on human health. The effects of ECs compared with TC on vascular function, inflammation and oxidative stress are unknown. It is increasingly recognised that nicotine itself has significant atherothrombotic effects. Therefore, clinicians are unable to confidently recommend ECs as a less risky alternative to TC.
Hypothesis: Endothelial function will be improved on EC compared to TC when measured by flow mediated dilatation (FMD).
Potential benefit: This study will provide further information on the potential use these devices and the risks and/or benefits associated with them, specifically in relation to vascular health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tobacco cigarette | Active Comparator | Intervention: tobacco cigarettes min 15/day |
|
| e.cigarettes + 16mg nicotine & flavor | Active Comparator | Intervention: One flavoured electronic cigarette 16mg nicotine/day |
|
| e.cigarettes + 0mg nicotine & flavour | Active Comparator | Intervention: One electronic cigarette with flavour +0mg nicotine/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electronic cigarette + 16mg nicotine & flavor | Device | comparison of different strengths of nicotine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups | Baseline and 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FMD between EC-nicotine and EC-nicotine free groups | Baseline and 1 month | |
| Change in FMD between TC and EC groups combined | Baseline and 1 month | |
| Change in oxidised LDL between the TC, EC-nicotine free and EC-nicotine groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob George | University of Dundee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Dundee | Dundee | Tayside | DD1 9SY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31740017 | Derived | George J, Hussain M, Vadiveloo T, Ireland S, Hopkinson P, Struthers AD, Donnan PT, Khan F, Lang CC. Cardiovascular Effects of Switching From Tobacco Cigarettes to Electronic Cigarettes. J Am Coll Cardiol. 2019 Dec 24;74(25):3112-3120. doi: 10.1016/j.jacc.2019.09.067. Epub 2019 Nov 15. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2018 | Jan 31, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 24, 2018 | Jan 31, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D066300 | Electronic Nicotine Delivery Systems |
| D009538 | Nicotine |
| D005421 | Flavoring Agents |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| electronic cigarette + 0mg nicotine & flavor | Other | comparison of different strengths of nicotine |
|
|
| Tobacco cigarette | Other | Participant to remain on traditional cigarettes for 28 days |
|
|
| Baseline and 1 month |
| Change in PAI-1 between the TC, EC-nicotine free and EC-nicotine groups | Baseline and 1 month |
| Change in hs-CRP between the TC, EC-nicotine free and EC-nicotine groups | Baseline and 1 month |
| Change in Pulse Wave Velocity between the TC group and the EC-nicotine free groups. | Baseline and 1 month |
| Change in tPA between the TC, EC-nicotine free and EC-nicotine groups | Baseline and 1 month |
| Change in Augmentation Index@75bpm between the TC group,EC-nicotine and the EC-nicotine free groups | Baseline and 1 month |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D005503 | Food Additives |
| D000074385 | Food Ingredients |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |