Clinical trial NCT02307032: Atrial Fibrillation Prediction Trial.
Official title: Atrial Fibrillation Prediction Trial of the Dynamic Changes Through the Continuous Spectrum of the Arrhythmia Evolution.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation Relapses Prediction
P wave Signal Averaged ECG
P wave Wavelets
Strain
Tissue Doppler Imaging
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include \> 500 patients 30-80 years old.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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:

* 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

Primary outcomes:
measure: Atrial Fibrillation Relapse
timeFrame: 12 months
Secondary outcomes:
measure: Permanent Atrial Fibrillation
timeFrame: 36 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Cardiology Department, Hippokration Hospital
state: Attiki
city: Athens
country: Greece
facility: First Department of Cardiology, Medical School, National & Kapodistrian University of Athens
state: Attiki
city: Eleysina
country: Greece
facility: Cardiology Department Thriasio Hospital
state: Attiki
city: Marousi
country: Greece
facility: Cardiology Department, Sismanogleion Hospital
Study officials:
affiliation: First Department of Cardiology, Medical School, National & Kapodistrian University of Athens, Greece
name: Petros Arsenos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: