Cardiac ArrhythmiasARIANCT01723761
Correlations Between Arrhythmias and Air Pollution in Patients With Pacemaker and ICD
An observational study of Cardiac Arrhythmias, run by Effect Group, Italy at 9 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiac Arrhythmias
- How many people
- 473 participants
- Where
- 9 sitesItaly
- Study dates
- Apr 2011to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males and females, aged ≥ 18 years of age who have been implanted with a dual-chamber pacemaker, an ICD or ICD-CRT.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites
Ospedale S.Maria dei Battuti - Cardiologia
Conegliano, 31015
Ospedale di ESte
Este, 35042
Mater Salutis
Legnago, 37045
Dell'Angelo Hospital
Mestre, 30175
Ospedale Civile
Mirano, 30039
Ospedale S. Valentino
Montebelluna, 31044
Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova
Padova, 35128
Civic Hospital
Portogruaro, 30026
Ospedale Ca' Foncello - Divisione di Cardiologia
Treviso, 31100
About this study
Official title: Correlations Between Arrhythmias, Climatic Variables and Air Pollution in Patients With Pacemaker and ICD, Followed by Remote Monitoring.
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.
Read more
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.
Read the 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.
- Conditions
- Cardiac Arrhythmias
- Keywords
- air pollution, pacemaker, ICD, remote monitoring, supraventricular arrhythmias, ventricular arrhythmias
- Medical subject headings
- Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12-24 months
Secondary outcomes (5)
Mean heart rate
Mean heart rate obtained by remote monitoring of pacemaker and ICDs.
Measured: 12-24 months
Heart rate variability
Measures of heart rate variability calculated by devices and obtained by remote monitoring.
Measured: 12-24 months
Percentage of paced beats
Percentage of paced beats will be measured by devices diagnostic and obtained via remote monitoring.
Measured: 12-24 months
Mortality for myocardial infarction or heart failure.
Measured: 12-24 months
Hospitalization for myocardial infarction or heart failure.
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startApr 2011
- Primary completionNov 2013
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- Effect Group, Italy
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Gianfranco Buja, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723761
- Sponsor's protocol ID
- ARIAPOL 01
- Acronym
- ARIA
- Status last verified
- Jul 2015
- First submitted
- 23 Oct 2012
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29851582
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlations Between Arrhythmias, Climatic Variables and Air Pollution in Patients With Pacemaker and ICD, Followed by Remote Monitoring.
- ClinicalTrials.gov ID
- NCT01723761
- Acronym / sponsor ID
- ARIA / ARIAPOL 01
- Conditions
- Cardiac Arrhythmias
- Keywords
- air pollution, pacemaker, ICD, remote monitoring, supraventricular arrhythmias, ventricular arrhythmias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- Effect Group, ItalyResearch network
- Study start
- Apr 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females, aged ≥ 18 years of age who have been implanted with a dual-chamber pacemaker, an ICD or ICD-CRT.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of atrial arrhythmias.
Time frame: 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.
incidence of ventricular arrhythmias
Time frame: 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.
5 secondary outcomes
Mean heart rate
Time frame: 12-24 months
Heart rate variability
Time frame: 12-24 months
Percentage of paced beats
Time frame: 12-24 months
Mortality for myocardial infarction or heart failure.
Time frame: 12-24 months
Hospitalization for myocardial infarction or heart failure.
Time frame: 12-24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
- Derived from this study: PubMed 29851582Folino 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianfranco Buja, MD principal investigator
University of Padova
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmias, run by Effect Group, Italy at 9 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of atrial arrhythmias. (time frame: 12- 24 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01723761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2015.