Skip to main content
OpenTrials
Completed

NCT Number: NCT01405209

Electrocardiogram Variations in the Prediction of Development of Atrial Fibrillation

Atrial fibrillation (AF) is the most common arrhythmia, affecting 1% of adults, with its prevalence increasing with age [1]. It is associated with increased morbidity and mortality.

Most patients who develop AF have architectural and anisotropic micro changes in the atrial myocardium. These cause heterogeneous and discontinuous changes in the patterns of impulse propagation, heterogeneous atrial activation and shortening of atrial refractory period [2, 3].

Since 1911 the standard EKG [4] (approximately 15 seconds of recording and bandwidth 0.05 to 150 Hz) is the most used tool for the evaluation of patients with arrhythmias, due to its low cost and high availability. Various electrocardiographic patterns are known predictors of AF as evidenced by direct visual inspection. For example, prolongation of P wave duration during sinus rhythm would correlate with structural changes such as increasing the size of the left atrium (the increase in left atrial pressure) or a decrease in driving time [5]. These changes favor the development of reentry circuits responsible for the development and maintenance of AF.

The registration of the electrocardiographic activity provides much more information than evidenced by direct visual inspection. Biosignal processing of these specific techniques to detect potential delays caused by abnormal conduction of the myocardium that favor re-entry mechanisms [6-10]. For this purpose prolonged ECG with 1000 Hz sampling frequency. Knowledge about the prediction of the development of AF with the standard ECG is not obvious on visual inspection is limited.

Many of these structural changes and anisotropic, occur slowly over time and may be evidenced by direct variations between 2 ECG from the same individual [11]. Little is known about whether differences in morphology, axis, scope or duration of P wave related to these structural changes may predict the development of AF.

Our main purpose is to evaluate the prognostic performance of a set of parameters as evidenced by direct inspection of the ECG, and ECG changes from 2 to predict the FA development. The design of this tool could allow future generation of software capable of identifying and reporting these variations, most useful prognostic risk in patients with AF.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Italiano de Buenos AIres

Buenos Aires, Argentina

About this study

Retrospective cohort of patients 18 years or older with 2 EKG with sinusal rithm between 2004 - 2011.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 years Health Plan members of the Italian Hospital of Buenos Aires with at least 2 ECG separated .

Exclusion criteria

  • Patients with sinus rhythm different.
  • Patients with a history of congenital heart disease (tetralogy of fallot, CIA)
  • Patients with implanted defibrillator or pacemaker.
  • Patients with a history of cardiac surgery or performing heart surgery from the last ECG and the development of AF.
  • Patients with a history of radiofrequency ablation for treatment of arrhythmias.

Treatment and study plan

Primary outcomes

  1. Variations (differences or deltas) between 2 standard ECG separated in time

    Time frame: at least 20 days after the first ekg

    To describe and evaluate the association between the variations (differences or deltas) between 2 standard ECG separated in time (eg difference in p-wave amplitude, difference in wavelength p) to predict development of AF

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Official study title

Variaciones En El Elctrocardiograma Como Prediccion Del Desarrollo De Fibrilacion AURIC

Acronym: EKG

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 29, 2011
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.