Vaping Adverse Lung and Heart Events Cohort

NCT06291597 | Recruiting

• 1 other identifier: 22071
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study assesses the pulmonary and cardiovascular effets of vaping in adult electronic cigarette users with biannual visits and a 5-year follow-up.

Conditions

Vaping; Electronic Cigarette Use

Keywords

Vaping; Vape; Electronic cigarette; Electronic and vaping acute lung injury; EVALI

Outcome Measures

Primary Outcomes (7)

• Number of participants who vape daily with impaired lung volumes.

  Participants will perform plethysmography assessments to measure changes in lung volumes. Data will be expressed as a percentage of predicted values.

  Every 6 months for 5 years

• Number of participants who vape daily with impaired lung diffusion capacity.

  Participants will perform diffusion capacity of the lung for carbon monoxide (DLCO) measures to assess changes in lung diffusion capacity. Data will be expressed as a percentage of predicted values.

  Every 6 months for 5 years

• Number of participants who vape daily with impaired spirometry.

  Participants will perform spirometry tests measures to assess changes in forced expiratory lung volumes. Data will be expressed as a percentage of predicted values.

  Every 6 months for 5 years

• Number of participants who vape daily with airway hyperresponsiveness.

  Participants will perform methacholine provocation challenge measures to assess changes in airway hyperresponsiveness. Data will be expressed as the methacholine concentration inducing a fall of 20% of forced expiratory volume in the first second assessed (PC20).

  Every 6 months for 5 years

• Number of participants who vape daily with changes in blood cell count.

  Participants will perform a blood draw to assess blood cell count. Data will be expressed as a percentage of eosinophils, neutrophils, macrophages and lymphocytes of the total cell count.

  Every 6 months for 5 years

• Number of participants who vape daily with changes in sputum cell count.

  Participants will perform sputum inductions to assess cell count in the sputum. Data will be expressed as a percentage of eosinophils, neutrophils, macrophages and lymphocytes of the total cell count.

  Every 6 months for 5 years

• Vaping, tobacco and cannabis smoking habits of participants.

  Participants will complete questionnaires assessing their vaping habits, tobacco smoking and cannabis smoking history.

  Every 3 months for 5 years

Study Arms (1)

Daily electronic cigarette users

Participants must use their vaping device everyday at time of enrollment.

Other: Vaping

Interventions

Vaping OTHER

Participants use their vaping products at their own discretion and their intake is monitored via questionnaires.

Daily electronic cigarette users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We seek to recruit 250 volunteers from the community with twice-a-year visits for a 5-year follow-up. We will recruit healthy volunteers as well as volunteers who have been previously diagnosed with chronic illness.

You may qualify if:

• Age 18 years or older
• Daily electronic cigarette user
• No respiratory infection in the 4 weeks before a visit

You may not qualify if:

• Women who are pregnant or breast-feeding.

Sponsors & Collaborators

• Laval University: lead
• Ministere de la Sante et des Services Sociaux: collaborator

Study Sites (1)

IUCPQ-UL

Québec, G1V 4G5, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Buffy coat obtained from plasma

MeSH Terms

Conditions

Vaping; Lung Injury

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Smoking; Behavior; Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mathieu C Morissette, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariane Lechasseur, PhD

CONTACT

418-656-8711; ariane.lechasseur@criucpq.ulaval.ca

Mathieu C Morissette, PhD

CONTACT

418-656-8711; mathieu.morissette@criucpq.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2023
• First Posted: March 4, 2024
• Study Start: October 14, 2021
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): June 1, 2032
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)