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Electronic Cigarette

E-Cigarette Exposure for Vascular Reactivity (AeCE Trial)

N/A
Recruiting
Led By Felix W Wehrli, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-inhalation (baseline) to post-inhalation (60 minutes)
Awards & highlights

AeCE Trial Summary

This trial will use MRI and blood tests to study the effects of electronic cigarettes with and without nicotine, compared to regular cigarettes, on vascular reactivity and inflammation.

Who is the study for?
This trial is for adults with a BMI of 18.5 to 30 who have been using electronic or tobacco cigarettes for at least six months. It's not suitable for individuals with mental illness impairing judgment, cancer, HIV, significant heart or brain vascular disease, serious arrhythmias, severe lung conditions like asthma, recent respiratory infections, those on medication affecting blood vessels or anyone unable to undergo MRI scans due to metal implants or claustrophobia.Check my eligibility
What is being tested?
The study investigates how different smoking methods (electronic and nicotine cigarettes) affect blood vessel function and inflammation markers in the body. Participants will experience three exposure sessions followed by MRI scans and blood tests before and after each session. Results from smokers/vapers will be compared with non-smokers/non-vapers.See study design
What are the potential side effects?
Potential side effects may include discomfort from nicotine intake such as dizziness or nausea; reactions related to the MRI procedure like anxiety in confined spaces; bruising from blood draws; and temporary changes in vascular reactivity.

AeCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-inhalation (baseline) to post-inhalation (60 minutes)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-inhalation (baseline) to post-inhalation (60 minutes) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in blood inflammatory biomarkers
Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: aortic arch
Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: blood flow velocity
+3 more

AeCE Trial Design

2Treatment groups
Experimental Treatment
Group I: VapersExperimental Treatment2 Interventions
Electronic cigarette vapers
Group II: SmokersExperimental Treatment2 Interventions
Conventional tobacco cigarette smokers

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,993 Previous Clinical Trials
42,875,523 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,683 Previous Clinical Trials
6,930,818 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,819 Previous Clinical Trials
47,295,717 Total Patients Enrolled

Media Library

Nicotine Research Cigarette (Electronic Cigarette) Clinical Trial Eligibility Overview. Trial Name: NCT05271578 — N/A
Serum Biomarkers Research Study Groups: Smokers, Vapers
Serum Biomarkers Clinical Trial 2023: Nicotine Research Cigarette Highlights & Side Effects. Trial Name: NCT05271578 — N/A
Nicotine Research Cigarette (Electronic Cigarette) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05271578 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total participant count for this research endeavor?

"Affirmative. According to information available on clinicaltrials.gov, this medical trial is actively recruiting patients and was initially posted on June 7th 2022 before its most recent update on June 21st 2022. 40 participants are needed from one location for the study's duration."

Answered by AI

Does the age cap for this clinical research exclude those below 40?

"This research is looking for individuals aged 18 to 45 that are willing to participate."

Answered by AI

What type of participants is this experiment best suited for?

"This research investigation is searching for 40 individuals aged 18 to 45 that possess vascular reactivity. To be considered, candidates must have a BMI between 18.5 and 30, as well as 6 months or more of experience using e-cigarettes or traditional cigarettes."

Answered by AI

Is enrollment to this trial currently accessible for participants?

"Affirmative. As evidenced on clinicaltrials.gov, this trial is actively recruiting patients with the initial post date being June 7th 2022 and a recent update occurring on June 21st 2022. The study needs to enrol 40 participants across 1 site."

Answered by AI
~6 spots leftby Aug 2024