Clinical trial NCT01723761: Correlations Between Arrhythmias and Air Pollution in Patients With Pacemaker and ICD
Official title: Correlations Between Arrhythmias, Climatic Variables and Air Pollution in Patients With Pacemaker and ICD, Followed by Remote Monitoring.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmias
Keywords: air pollution
pacemaker
ICD
remote monitoring
supraventricular arrhythmias
ventricular arrhythmias
Lead sponsor: Effect Group, Italy
Sponsor class: NETWORK
First posted: 2012-11-08
Enrollment: 473
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females, aged ≥ 18 years of age who have been implanted with a dual-chamber pacemaker, an ICD or ICD-CRT.

Brief summary: 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.

Detailed description: 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.

The study will include 500 subjects and will consist of two periods:

Screening: we will collect baseline characteristics of subjects in the clinical examination. The period recruitment will run for 12 months.

Follow-up: After written informed consent will be signed, subjects who meet the criteria for inclusion will be enrolled in the study and followed up for a minimum period of 12 months. The data obtained from the remote monitoring will be evaluated for the daily values provided for the parameters considered in the study.

Periodical visits in pacemaker clinic will be scheduled at the discretion of the referring cardiologist of the center. The arrhythmic events that will occur in this period, detected by means of remote monitoring or through other clinical evaluations will be recorded. Atrial arrythmias: atrial fibrillation or atrial flutter, supraventricular tachycardia.

Ventricular arrhythmias: ventricular tachycardia, ventricular fibrillation, ventricular extrasystoles.

Physiological variables: average heart rate (24 hours and at rest), heart rate variability, the percentage of paced beats.

In addition, any changes in drug therapies and all clinically relevant events, will be recorded.

During the same period data from monitoring stations of ARPAV (Regional Agency for Environmental Prevention and Protection of Veneto Region) will be collected.

Climatic variables: temperature, humidity, atmospheric pressure. Parameters of air pollution: PM10, PM2.5, O3, CO, SO2, NO2. For each patient, the data from the monitoring station ARPAV of the urban area of residence of the subject will be considered. The mean exposure level used in the analytical studies on the health effects is calculated on the average number of units active in the area. This number is usually of 2-3 units in large centers, while it is generally only 1 in small towns. The residents in centers without monitoring will be excluded from the study. The mean value is the best approximation ... to be continued page 6.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: incidence of atrial arrhythmias.
timeFrame: 12- 24 months.
measure: incidence of ventricular arrhythmias
timeFrame: 12-24 months
Secondary outcomes:
measure: Mean heart rate
timeFrame: 12-24 months
measure: Heart rate variability
timeFrame: 12-24 months
measure: Percentage of paced beats
timeFrame: 12-24 months
measure: Mortality for myocardial infarction or heart failure.
timeFrame: 12-24 months
measure: Hospitalization for myocardial infarction or heart failure.
timeFrame: 12-24 months
Other outcomes:
Locations:
city: Conegliano
country: Italy
facility: Ospedale S.Maria dei Battuti - Cardiologia
city: Este
country: Italy
facility: Ospedale di ESte
city: Legnago
country: Italy
facility: Mater Salutis
city: Mestre
country: Italy
facility: Dell'Angelo Hospital
city: Mirano
country: Italy
facility: Ospedale Civile
city: Montebelluna
country: Italy
facility: Ospedale S. Valentino
city: Padova
country: Italy
facility: Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova
city: Portogruaro
country: Italy
facility: Civic Hospital
city: Treviso
country: Italy
facility: Ospedale Ca' Foncello - Divisione di Cardiologia
Study officials:
affiliation: University of Padova
name: Gianfranco Buja, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Folino F, Buja G, Zanotto G, Marras E, Allocca G, Vaccari D, Gasparini G, Bertaglia E, Zoppo F, Calzolari V, Suh RN, Ignatiuk B, Lanera C, Benassi A, Gregori D, Iliceto S. Association between air pollution and ventricular arrhythmias in high-risk patients (ARIA study): a multicentre longitudinal study. Lancet Planet Health. 2017 May;1(2):e58-e64. doi: 10.1016/S2542-5196(17)30020-7. Epub 2017 May 5.