NCT02777515: ECLOPE

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

Terminated NA Last updated 30 May 2018

What this trial tests

NA trial testing using electronic cigarette in CARDIOVASCULAR DISEASES in 5 participants. Terminated before completion.

Timeline

30 October 2015

Primary endpoint
5 December 2015

1 June 2016

Quick facts

Lead sponsor	Fondation Hôpital Saint-Joseph
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	5
Start date	30 October 2015
Primary completion	5 December 2015
Estimated completion	1 June 2016
Sites	1 location across France

Drugs / interventions tested

• using electronic cigarette

Conditions studied

• CARDIOVASCULAR DISEASES — all drugs for CARDIOVASCULAR DISEASES →

Sponsor

Fondation Hôpital Saint-Joseph — full company profile →

Who can join

Adults 18 to 35, any sex, with CARDIOVASCULAR DISEASES. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.