Pilot Study of the Immediate Cardiovascular Effects of Electronic Cigarette in Subjects With Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Assessment of change of blood pressure
研究概览
简要总结
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
详细描述
I. Introduction
The objective of this study was to evaluate the acute cardiovascular effects of electronic cigarette in young patients by non-invasive methods.
II. State of the question and justification for the research
State of the question
Coronary artery disease is the death rate cause, responsible for around 7 million deaths each year, or 12.8% of causes of death. Myocardial infarction has an incidence of 66/100 000 inhabitants per year. It is now undoubtedly recognized that smoking is a major independent cardiovascular risk factor and tobacco is responsible for over 5 million deaths per year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Subjects also smoking a conventional cigarette or using other nicotine substitutes will be excluded
研究组 & 干预措施
Patients using electronic cigarette
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.
干预措施: using electronic cigarette (Behavioral)
结局指标
主要结局
Assessment of change of blood pressure
时间窗: before smoking then 15 min after smoking
Assessment of change of transthoracic echocardiogram
时间窗: before smoking then 15 min after smoking
Assessment of change of Holter-ECG
时间窗: before smoking then 15 min after smoking
Assessment of change of Electrocardiogram (ECG)
时间窗: before smoking then 15 min after smoking
次要结局
未报告次要终点