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

NCT02777515 | Terminated DMC

• 1 other identifier: ECLOPE
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

CARDIOVASCULAR DISEASES

Keywords

electronic cigarette

Outcome Measures

Primary Outcomes (4)

• Assessment of change of blood pressure

  before smoking then 15 min after smoking

• Assessment of change of Electrocardiogram (ECG)

  before smoking then 15 min after smoking

• Assessment of change of Holter-ECG

  before smoking then 15 min after smoking

• Assessment of change of transthoracic echocardiogram

  before smoking then 15 min after smoking

Study Arms (1)

Patients using electronic cigarette

OTHER

The patients under the age of 35 followed at the consultation of rythmology for a cardiovascular assessment and already smoking the electronic cigarette and this since at least 1 month. The patient will receive a clinical examination, an electrocardiogram, a Holter-ECG and an echocardiogram before and after electronic cigarette consumption for 15 minutes.

Behavioral: using electronic cigarette

Interventions

using electronic cigarette BEHAVIORAL

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

Patients using electronic cigarette

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged under 35 years
• Having no known heart disease
• Not consuming any toxic
• Already smoking the electronic cigarette and that for at least one month to ensure good tolerance of the electronic cigarette

You may not qualify if:

• Subjects also smoking a conventional cigarette or using other nicotine substitutes will be excluded

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Ghassan MOUBARAK, MD

  Groupe Hospitalier Paris Saint-Joseph (FRANCE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 19, 2016
• Study Start: October 30, 2015
• Primary Completion: December 5, 2015
• Study Completion: June 1, 2016
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

FR (1)