Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-03-06 @ 2:03 PM
Study NCT ID:
NCT05454267
Status:
RECRUITING
Last Update Posted:
2025-05-28
First Post:
2022-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Detection of Vaping-related Vascular Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072137', 'term': 'Vaping'}, {'id': 'D057772', 'term': 'Vascular System Injuries'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Oral swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-25', 'studyFirstSubmitDate': '2022-06-30', 'studyFirstSubmitQcDate': '2022-07-07', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Airway blood flow reactivity (QAW)', 'timeFrame': 'Up to 1 week', 'description': 'QAW will be measured via soluble gas uptake method'}, {'measure': 'Pulmonary vascular resistance (PVR)', 'timeFrame': 'Up to 4 weeks', 'description': 'PVR will be measured via echocardiography'}, {'measure': 'Flow-mediated vasodilation (FMD)', 'timeFrame': 'Up to 4 weeks', 'description': 'FMD will be measured by blood pressure cuff deflation using ultrasound'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaping', 'Blood Vessel Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how vaping affects blood vessels, in particular if early damage occurs in the lung vessels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy non smokers and vapers residing in Florida', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nVapers Group:\n\n1. Current electronic cigarette (EC) Puff Bar users defined as using EC either daily or occasionally in the past 30 days for at least 6 months, and with 5% nicotine concentration pods.\n2. Adults aged 18-40 years\n\nHealthy Group:\n\n1. Healthy never smokers, never vapers\n2. Adults aged 18-40 years\n\nExclusion Criteria:\n\n1. Current or past smoking of tobacco cigarette (TC) or other tobacco/nicotine products (e.g., smokeless tobacco, Hookah) or marijuana will be excluded from the study.\n2. Subjects with self-reported history of chronic health problems including asthma, chronic obstructive pulmonary disease (COPD), morbid obesity (BMI\\>40 kg/m2), hypertension or diabetes\n3. Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT05454267', 'acronym': 'ENDS', 'briefTitle': 'Early Detection of Vaping-related Vascular Diseases', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Early Detection of Vaping-related Vascular Diseases', 'orgStudyIdInfo': {'id': '20211060'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Volunteer Group', 'description': 'Participants who have never smoked or vaped'}, {'label': 'High Frequency Vaping Group', 'description': 'Participants who vape \\>20 days per month.'}, {'label': 'Low-Frequency Vaping Group', 'description': 'Participants who vape \\< 20 days per month'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Campos, MD', 'role': 'CONTACT', 'email': 'mcampos1@med.miami.edu', 'phone': '3052436388'}, {'name': 'Adam Wanner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael Campos, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Barry Hurwitz, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Taghrid Asfar, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Miami Health System', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Adam Wanner, MD', 'role': 'CONTACT', 'email': 'awanner@med.miami.edu', 'phone': '(305)243-2568'}, {'name': 'Michael Campos, MD', 'role': 'CONTACT', 'email': 'mcampos1@med.miami.edu', 'phone': '3052436388'}], 'overallOfficials': [{'name': 'Adam Wanner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Florida Department of Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Adam Wanner', 'investigatorAffiliation': 'University of Miami'}}}}