Correlations Between Arrhythmias, Climatic Variables and Air Pollution in Patients With Pacemaker and ICD, Followed by Remote Monitoring.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 473
- 试验地点
- 9
- 主要终点
- incidence of ventricular arrhythmias
研究概览
简要总结
It is a clinical, observational study to evaluate the correlations among arrhythmias, climatic variables and air pollution in patients with pacemaker and implantable defibrillator (ICD), followed by remote monitoring.
Purpose of the Study: The purpose of this study is to test the hypothesis that changes in climatic variables, such as temperature, pressure and humidity, and changes of particulate matter <10µ (PM10), particulate matter <2.5µ (PM2.5), ozone (O3), carbon monoxide (CO), sulfur dioxide (SO2), nitrogen dioxide (NO2), are associated with an increase of supraventricular and ventricular arrhythmias.
Objectives: The aim of this study is to determine whether changes in variables conditions affect the electrical stability of the myocardium in patients with pacemakers and ICDs.
Population: male and female subjects, aged ≥ 18 years, implanted by a dual-chamber pacemaker, ICD or biventricular ICD (ICD-CRT). A total of 500 subjects from 15 cardiology centers of the Veneto region will be included.
详细描述
The primary objectives of this study are as follows:
- Determine if the changes of temperature, pressure and humidity, are associated with an increase of atrial and ventricular arrhythmias.
- Determine if the changes of air pollution (gas and particulate), are associated with an increase of atrial and ventricular arrhythmias.
The secondary objectives of the study are:
- Determine if the changes of air pollution (gas and particulate), are associated with significant changes in mean heart rate, rate variability rate and the percentage of paced beats.
- Determine whether changes in temperature, pressure or humidity, are associated with significant changes in mean heart rate, heart rate variability and the percentage of paced beats.
- Determine if the changes of temperature, pressure and humidity, are associated with an increase in mortality or hospitalization for myocardial infarction or congestive heart failure.
- Determine if the changes of air pollution (gas and particulate), are associated with an increase in mortality or hospitalization for myocardial infarction or congestive heart failure.
Study Design This is a prospective, observational study, which compares the occurrence of atrial and ventricular arrhythmias and changes in physiological parameters, with climatic variables and air pollution.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable subjects,> 18 years, who have been implanted with a dual-chamber pacemaker, an ICD or ICD-CRT, compatible with remote monitoring systems, with daily transmission of data.
排除标准
- •Presence of heart failure clinically manifest.
- •Concomitant illness or a significant condition which severely limits the life expectancy.
- •Any medical or surgical condition that, at the discretion of the investigator, places the patient at higher risk for his participation in the study.
- •History of malignancy of any organ system in the last two years, whether treated or untreated, including leukemia and lymphoma (with the exception of basal cell carcinoma of the skin) if there is evidence of local recurrence of metastasis.
- •History of drug or alcohol abuse in the last 2 years.
- •Participation in another study of a drug or device within 30 days after randomization.
- •Inability to communicate and to comply with all such obligations including the unwillingness or inability to give an informed consent.
- •Residence in urban centers without environmental monitoring.
结局指标
主要结局
incidence of ventricular arrhythmias
时间窗: 12-24 months
The arrhythmic events that will occur during follow-up period, detected by remote monitoring or through other clinical evaluations, will be recorded and classified as follows: ventricular tachycardia, ventricular fibrillation, premature ventricular beats.
incidence of atrial arrhythmias.
时间窗: 12- 24 months.
The arrhythmic events that will occur during follow-up period, detected by remote monitoring or through other clinical evaluations, will be recorded and classified as follows: atrial fibrillation or atrial flutter, supraventricular tachycardia.
次要结局
- Percentage of paced beats(12-24 months)
- Mortality for myocardial infarction or heart failure.(12-24 months)
- Mean heart rate(12-24 months)
- Heart rate variability(12-24 months)
- Hospitalization for myocardial infarction or heart failure.(12-24 months)