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Study of the Immediate Cardiovascular Effects of Electronic Cigarette in Subjects With Cardiovascular Disease

NCT02777515 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-05-30

No results posted yet for this study

Summary

Justification Smoking is a major factor for mortality and cardiovascular morbidity. The electronic cigarette, sometimes presented as smoking cessation "classic" is expanding but its safety has not been established to date. The smoke from the electronic cigarette is mainly composed of propylene glycol, some adverse effects were observed in animals.

Study Type interventional study assessing the effect of the electronic cigarette Inclusion criteria Topics under 35 years presenting to Rhythm of the consultation for a cardiovascular evaluation and already smoking the electronic cigarette and that for at least 1 month

Exclusion criteria

* Consumption of traditional cigarettes, nicotine replacement or toxic
* Presence of heart disease Primary objective To evaluate in a pilot study the immediate cardiovascular effects of electronic cigarette consumption Number of patients 20 Duration of Study Recruitment in 2015 for an unlimited period of inclusion. Exam time is about two hours.

Procedures performed during the study Physical examination, ECG, Holter-ECG 10 minutes and echocardiography were performed before and 15 minutes after the consumption of the usual electronic cigarette of the subject.

No additional follow-up visit is required

Conditions

Interventions

BEHAVIORAL

using electronic cigarette

Assesment of patients, using electronic cigarette, presenting to the Rhythm of consultation for a cardiovascular evaluation by: 1. A compendium of history, a general physical examination (weight, height) and cardiovascular with measurement of oxygen saturation, an assessment of past and current smoking (with documentation of the concentration of nicotine in the electronic cigarette and the product brand used) 2. measurement of blood pressure 3. An electrocardiogram 4. A Holter-ECG 10 minutes 5. A transthoracic echocardiogram

Sponsors & Collaborators

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Principal Investigators

  • Ghassan MOUBARAK, MD · Groupe Hospitalier Paris Saint-Joseph (FRANCE)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-30
Primary Completion
2015-12-05
Completion
2016-06-01

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02777515 on ClinicalTrials.gov