Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 6:40 PM
Study NCT ID:
NCT05757934
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-10
First Post:
2023-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Long-term Cardiovascular Effects of Vaping
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000072137', 'term': 'Vaping'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 172}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-09', 'studyFirstSubmitDate': '2023-02-07', 'studyFirstSubmitQcDate': '2023-02-23', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brachial artery FMD using ultrasound', 'timeFrame': '24 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Brachial artery FMD using ultrasound', 'timeFrame': '3 months', 'description': 'As in 24 months.'}, {'measure': 'Brachial artery FMD using ultrasound', 'timeFrame': '6 months', 'description': 'As in 24 months.'}, {'measure': 'Brachial artery FMD using ultrasound', 'timeFrame': '12 months', 'description': 'As in 24 months.'}, {'measure': 'Brachial artery FMD using ultrasound', 'timeFrame': '18 months', 'description': 'As in 24 months.'}, {'measure': 'Vascular assessment of biomarkers', 'timeFrame': '24 months', 'description': '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.'}, {'measure': 'Vascular assessment of biomarkers', 'timeFrame': '12 months', 'description': '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.'}, {'measure': 'Vascular assessment of biomarkers', 'timeFrame': '6 months.', 'description': '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.'}, {'measure': 'Vascular assessment of biomarkers', 'timeFrame': '18 months', 'description': '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.'}, {'measure': 'Lung function', 'timeFrame': '24 months', 'description': 'Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).'}, {'measure': 'Lung function', 'timeFrame': '6 months', 'description': 'Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).'}, {'measure': 'Lung function', 'timeFrame': '12 months', 'description': 'Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).'}, {'measure': 'Lung function', 'timeFrame': '18 months', 'description': 'Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).'}, {'measure': 'Smoking dependence', 'timeFrame': 'baseline', 'description': 'Using Fagerström questionnaire.'}, {'measure': 'Vaping dependence', 'timeFrame': 'baseline', 'description': 'Using Vaping dependence questionnaire.'}, {'measure': 'Vaping dependence', 'timeFrame': '6 months', 'description': 'Using Vaping dependence questionnaire.'}, {'measure': 'Vaping dependence', 'timeFrame': '12 months', 'description': 'Using Vaping dependence questionnaire.'}, {'measure': 'Vaping dependence', 'timeFrame': '18 months', 'description': 'Using Vaping dependence questionnaire.'}, {'measure': 'Vaping dependence', 'timeFrame': '24 months', 'description': 'Using Vaping dependence questionnaire.'}, {'measure': 'Smoking dependence', 'timeFrame': '24 months', 'description': 'Using Fagerström questionnaire.'}, {'measure': 'Smoking dependence', 'timeFrame': '18 months', 'description': 'Using Fagerström questionnaire.'}, {'measure': 'Smoking dependence', 'timeFrame': '12 months', 'description': 'Using Fagerström questionnaire.'}, {'measure': 'Smoking dependence', 'timeFrame': '6 months', 'description': 'Using Fagerström questionnaire.'}, {'measure': 'Change in CV risk profile', 'timeFrame': '24 months', 'description': 'Q-risk assessment'}, {'measure': 'Change in CV risk profile', 'timeFrame': '18 months', 'description': 'Q-risk assessment'}, {'measure': 'Change in CV risk profile', 'timeFrame': '12 months', 'description': 'Q-risk assessment'}, {'measure': 'Change in CV risk profile', 'timeFrame': '6 months', 'description': 'Q-risk assessment'}, {'measure': 'Anthropometrics', 'timeFrame': 'baseline', 'description': 'height (m), weight (m) to calculate body mass index (BMI) as weight divided by height squared,'}, {'measure': 'Anthropometrics', 'timeFrame': '24 months', 'description': 'height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,'}, {'measure': 'Anthropometrics', 'timeFrame': '18 months', 'description': 'height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,'}, {'measure': 'Anthropometrics', 'timeFrame': '12 months', 'description': 'height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,'}, {'measure': 'Anthropometrics', 'timeFrame': '6 months', 'description': 'height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,'}, {'measure': 'Anthropometrics', 'timeFrame': 'baseline', 'description': 'heart rate variability (assessed as normal-to-normal (NN) intervals).'}, {'measure': 'Anthropometrics', 'timeFrame': 'baseline', 'description': 'blood pressure (mmHg).'}, {'measure': 'Anthropometrics', 'timeFrame': '6 months', 'description': 'blood pressure (mmHg).'}, {'measure': 'Anthropometrics', 'timeFrame': '12 months', 'description': 'blood pressure (mmHg).'}, {'measure': 'Anthropometrics', 'timeFrame': '18 months', 'description': 'blood pressure (mmHg).'}, {'measure': 'Anthropometrics', 'timeFrame': '24 months', 'description': 'blood pressure (mmHg).'}, {'measure': 'Anthropometrics', 'timeFrame': '24 months', 'description': 'heart rate variability (assessed as normal-to-normal (NN) intervals).'}, {'measure': 'Anthropometrics', 'timeFrame': '18 months', 'description': 'heart rate variability (assessed as normal-to-normal (NN) intervals).'}, {'measure': 'Anthropometrics', 'timeFrame': '12 months', 'description': 'heart rate variability (assessed as normal-to-normal (NN) intervals).'}, {'measure': 'Anthropometrics', 'timeFrame': '6 months', 'description': 'heart rate variability (assessed as normal-to-normal (NN) intervals).'}, {'measure': 'Smoking abstinence', 'timeFrame': '24 months', 'description': 'For Groups A, B and D smoking abstinence will be defined by the presence of CO \\< 10ppm'}, {'measure': 'Smoking abstinence', 'timeFrame': '18 months', 'description': 'For Groups A, B and D smoking abstinence will be defined by the presence of CO \\< 10ppm'}, {'measure': 'Smoking abstinence', 'timeFrame': '12 months', 'description': 'For Groups A, B and D smoking abstinence will be defined by the presence of CO \\< 10ppm'}, {'measure': 'Smoking abstinence', 'timeFrame': '6 months', 'description': 'For Groups A, B and D smoking abstinence will be defined by the presence of CO \\< 10ppm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vaping', 'macrocirculation', 'smoking', 'blood biomarkers'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': '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.\n\nRecent 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.\n\nTherefore, 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.\n\nThe 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).\n\nTwo-hundred participants from Sheffield and Leeds will be invited on five occasions (baseline, as well as 6-,12-,18- and 24-months post-baseline).\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Vapers conforming to specific group criteria in wider Sheffield and Leeds areas, in the U.K.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion Criteria: Age ≥18 years of either gender. Specific group inclusion criteria include:\n\nGroup 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.\n\nGroup 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.\n\nExclusion Criteria:\n\n* Non-ambulant people and people with a recent (e.g., within 6 months) CVD event (e.g. stroke, myocardial infarction) or cardiac surgery,\n* pregnancy,\n* people who require major surgery (which will prevent them of taking part in the study),\n* people who are unable or unwilling to give informed consent.'}, 'identificationModule': {'nctId': 'NCT05757934', 'acronym': 'LIGER', 'briefTitle': 'Exploring the Long-term Cardiovascular Effects of Vaping', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Hallam University'}, 'officialTitle': 'Exploring the Long-term Cardiovascular Effects of Vaping: a Longitudinal Study', 'orgStudyIdInfo': {'id': 'ER49341917'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'vapers, who are ex-smokers.'}, {'label': 'Group B', 'description': 'vapers with no previous smoking experience.'}, {'label': 'Group C', 'description': 'vapers, who are dual users (i.e., those who vape and smoke).'}, {'label': 'Group D', 'description': "ex-smokers who don't vape."}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S10 2BP', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Sheffield Hallam University', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Hallam University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Leeds Beckett University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Vascular and Clinical Physiology', 'investigatorFullName': 'Markos Klonizakis', 'investigatorAffiliation': 'Sheffield Hallam University'}}}}