Atrial FibrillationAFPRETNCT02307032
Atrial Fibrillation Prediction Trial.
An observational study of Atrial Fibrillation, run by University of Athens at 4 sites in Greece.
Trial summary
Atrial Fibrillation (AF) is a common arrhythmia with a prevalence of 1.5-2%. This prevalence increases significantly after 80 years of age. After the appearance of first episode(s) some of the patients will present frequent arrhythmia recurrences moving from the paroxysmal status to the persistent and the permanent… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 500 participants
- Where
- 4 sitesGreece
- Study dates
- Sep 2014to Dec 2020
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include > 500 patients 30-80 years old.
Who may be able to join
- Inclusion criteria is one up to five paroxysmal AF (PAF) episodes during the last three years. Patients during screening must maintaining Sinus Rhythm.
Who cannot join
- previous heart surgery, hyperthyroidism, severe diseases of the autonomic nervous system, alcoholism, diseases affecting seriously the survival and absence of adequate cooperation for the study
Trial locations and contacts
4 sites in 1 country.
Greece4 sites, 1 recruiting
- Active, not recruiting
Cardiology Department, Hippokration Hospital
Athens, Attica
- Active, not recruiting
First Department of Cardiology, Medical School, National & Kapodistrian University of Athens
Athens, Attica
- Active, not recruiting
Cardiology Department Thriasio Hospital
Eleysina, Attica
- Recruiting
Cardiology Department, Sismanogleion Hospital
Marousi
Dimitrios Mytas, MD, PhD
Dimitrios Mytas, MD, PhD
About this study
Official title: Atrial Fibrillation Prediction Trial of the Dynamic Changes Through the Continuous Spectrum of the Arrhythmia Evolution.
Atrial Fibrillation (AF) is a common arrhythmia with a prevalence of 1.5-2%. This prevalence increases significantly after 80 years of age. After the appearance of first episode(s) some of the patients will present frequent arrhythmia recurrences moving from the paroxysmal status to the persistent and the permanent status of the continuous spectrum of the natural time course of AF. In contrast some other will not present further relapses. To study and predict the dynamic evolution of AF is clinically important, furthermore, the detection of different sub populations risk for AF relapses will determine and different therapeutic approaches.
Read the detailed description
Atrial Fibrillation (AF) is a common arrhythmia with a prevalence of 1.5-2%. This prevalence increases significantly after 80 years of age. In the presence of the Arrhythmia the risk of stroke increases five fold while the congestive heart failure and the mortality rates are increasing significantly also.After the appearance of first episode(s) some of the patients will present frequent arrhythmia recurrences moving from the paroxysmal status to the persistent and the permanent status of the continuous spectrum of the natural time course of AF. In contrast some other will not present further relapses. To study and predict the dynamic evolution of AF is clinically important, furthermore, the detection of different sub populations risk for AF relapses will determine and different therapeutic approaches. The study will include > 500 patients 30-80 years old. Inclusion criteria is one up to five paroxysmal AF (PAF) episodes during the last three years. Patients during screening must maintaining Sinus Rhythm. Exclusion criteria are substrate of severe valvular diseases, congenital heart disease, previous heart surgery, hyperthyroidism, severe diseases of the autonomic nervous system, alcoholism, diseases affecting seriously the survival and absence of adequate cooperation for the study. Screening will include 12 lead surface digital ECG, 30 min High Resolution (1000 Hz) ECG recording from 3 pseudo orthogonal x,y,z leads system, and complete ECHO study (2D, PWD, TDI, Strain).Among other indices will be analyzed: P duration, P index, P dispersion, P wave signal for Late potentials, for Wavelets, PQ/RR Dynamics, Heart Rate Dynamics and various markers for the autonomic nervous system status.Primary end point is one or more PAF relapse(s) during a period of 12 months after recruitment in study.Secondary end point is permanent AF during a period of 36 months after recruitment in study.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation Relapses Prediction, P wave Signal Averaged ECG, P wave Wavelets, Strain, Tissue Doppler Imaging
- Medical subject headings
- Atrial Fibrillation, Sprains and Strains
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation Relapse
Primary end point is one or more PAF relapse(s) during a period of 12 months after recruitment in study.
Measured: 12 months
Secondary outcomes (1)
Permanent Atrial Fibrillation
Secondary end point is permanent AF during a period of 36 months after recruitment in study.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PETROS ARSENOS, University of Athens
- Investigators
- Petros Arsenos, MD, PhD, Principal investigator, First Department of Cardiology, Medical School, National & Kapodistrian University of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307032
- Sponsor's protocol ID
- 3037SH
- Other IDs
- 07062011
- Acronym
- AFPRET
- Status last verified
- Jan 2016
- First submitted
- 1 Dec 2014
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Prediction Trial of the Dynamic Changes Through the Continuous Spectrum of the Arrhythmia Evolution.
- ClinicalTrials.gov ID
- NCT02307032
- Acronym / sponsor ID
- AFPRET / 3037SH
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation Relapses Prediction, P wave Signal Averaged ECG, P wave Wavelets, Strain, Tissue Doppler Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 3 Dec 2014 (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.
Atrial Fibrillation (AF) is a common arrhythmia with a prevalence of 1.5-2%. This prevalence increases significantly after 80 years of age. After the appearance of first episode(s) some of the patients will present frequent arrhythmia recurrences moving from the paroxysmal status to the persistent and the permanent status of the continuous spectrum of the natural time course of AF. In contrast some other will not present further relapses. To study and predict the dynamic evolution of AF is clinically important, furthermore, the detection of different sub populations risk for AF relapses will determine and different therapeutic approaches.
Detailed description
Atrial Fibrillation (AF) is a common arrhythmia with a prevalence of 1.5-2%. This prevalence increases significantly after 80 years of age. In the presence of the Arrhythmia the risk of stroke increases five fold while the congestive heart failure and the mortality rates are increasing significantly also.After the appearance of first episode(s) some of the patients will present frequent arrhythmia recurrences moving from the paroxysmal status to the persistent and the permanent status of the continuous spectrum of the natural time course of AF. In contrast some other will not present further relapses. To study and predict the dynamic evolution of AF is clinically important, furthermore, the detection of different sub populations risk for AF relapses will determine and different therapeutic approaches. The study will include > 500 patients 30-80 years old. Inclusion criteria is one up to five paroxysmal AF (PAF) episodes during the last three years. Patients during screening must maintaining Sinus Rhythm. Exclusion criteria are substrate of severe valvular diseases, congenital heart disease, previous heart surgery, hyperthyroidism, severe diseases of the autonomic nervous system, alcoholism, diseases affecting seriously the survival and absence of adequate cooperation for the study. Screening will include 12 lead surface digital ECG, 30 min High Resolution (1000 Hz) ECG recording from 3 pseudo orthogonal x,y,z leads system, and complete ECHO study (2D, PWD, TDI, Strain).Among other indices will be analyzed: P duration, P index, P dispersion, P wave signal for Late potentials, for Wavelets, PQ/RR Dynamics, Heart Rate Dynamics and various markers for the autonomic nervous system status.Primary end point is one or more PAF relapse(s) during a period of 12 months after recruitment in study.Secondary end point is permanent AF during a period of 36 months after recruitment in study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include > 500 patients 30-80 years old.
Key inclusion criteria (1 listed)
- Inclusion criteria is one up to five paroxysmal AF (PAF) episodes during the last three years. Patients during screening must maintaining Sinus Rhythm.
Key exclusion criteria (1 listed)
- previous heart surgery, hyperthyroidism, severe diseases of the autonomic nervous system, alcoholism, diseases affecting seriously the survival and absence of adequate cooperation for the study
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
Atrial Fibrillation Relapse
Time frame: 12 months
Primary end point is one or more PAF relapse(s) during a period of 12 months after recruitment in study.
1 secondary outcome
Permanent Atrial Fibrillation
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
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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.
Petros Arsenos, MD, PhD principal investigator
First Department of Cardiology, Medical School, National & Kapodistrian University of Athens, Greece
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University of Athens at 4 sites in Greece.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petros Arsenos, MD, PhD (00306974338896, arspetr@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial Fibrillation Relapse (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2016.