Correlations Between Arrhythmias and Air Pollution in Patients With Pacemaker and ICD

NCT01723761 | Completed

• 1 other identifier: ARIAPOL 01
• Study Type: observational
• Target: 473
• Locations: 1 country
• Sites: 9

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.

Conditions

Cardiac Arrhythmias

Keywords

air pollution; pacemaker; ICD; remote monitoring; supraventricular arrhythmias; ventricular arrhythmias

Outcome Measures

Primary Outcomes (2)

• incidence of atrial arrhythmias.

  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.

  12- 24 months.

• incidence of ventricular arrhythmias

  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.

  12-24 months

Secondary Outcomes (5)

• Mean heart rate

  12-24 months

• Heart rate variability

  12-24 months

• Percentage of paced beats

  12-24 months

• Mortality for myocardial infarction or heart failure.

  12-24 months

• Hospitalization for myocardial infarction or heart failure.

  12-24 months

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Effect Group, Italy: lead

Study Sites (9)

Ospedale S.Maria dei Battuti - Cardiologia

Conegliano, 31015, Italy

Location

Ospedale di ESte

Este, 35042, Italy

Location

Mater Salutis

Legnago, 37045, Italy

Location

Dell'Angelo Hospital

Mestre, 30175, Italy

Location

Ospedale Civile

Mirano, 30039, Italy

Location

Ospedale S. Valentino

Montebelluna, 31044, Italy

Location

Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova

Padua, 35128, Italy

Location

Civic Hospital

Portogruaro, 30026, Italy

Location

Ospedale Ca' Foncello - Divisione di Cardiologia

Treviso, 31100, Italy

Location

Related Publications (1)

• 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.

  PMID: 29851582 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gianfranco Buja, MD

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: November 8, 2012
• Study Start: April 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: June 1, 2015
• Last Updated: July 2, 2015

Record last verified: 2015-07

Locations

IT (9)