Atrial Fibrillation Prediction Trial. (AFPRET)

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Petros Arsenos, MD, PhD; Phone Number: 00306974338896; Email: arspetr@otenet.gr

Study Locations

• Greece
  • Marousi, Greece
    • Recruiting
    • Cardiology Department, Sismanogleion Hospital
    • Contact: Dimitrios Mytas, MD, PhD
    • Sub-Investigator: Dimitrios Mytas, MD, PhD
  • Attiki
    • Athens, Attiki, Greece
      • Active, not recruiting
      • Cardiology Department, Hippokration Hospital
    • Athens, Attiki, Greece
      • Active, not recruiting
      • First Department of Cardiology, Medical School, National & Kapodistrian University of Athens
    • Eleysina, Attiki, Greece
      • Active, not recruiting
      • Cardiology Department Thriasio Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study will include > 500 patients 30-80 years old.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial Fibrillation Relapse	Primary end point is one or more PAF relapse(s) during a period of 12 months after recruitment in study.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Permanent Atrial Fibrillation	Secondary end point is permanent AF during a period of 36 months after recruitment in study.	36 months

Collaborators and Investigators

• Sponsor: University of Athens
• Investigators: Principal Investigator: Petros Arsenos, MD, PhD, First Department of Cardiology, Medical School, National & Kapodistrian University of Athens, Greece

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimate): December 3, 2014

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Strain; Tissue Doppler Imaging; Atrial Fibrillation Relapses Prediction; P wave Signal Averaged ECG; P wave Wavelets
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 3037SH; 07062011 (Other Identifier: Sismanogleion Hospital Marousi Greece)