Electrocardiogram Variations in the Prediction of Development of Atrial Fibrillation (EKG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01405209
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : March 24, 2015
Information provided by (Responsible Party):
Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires

Brief Summary:

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.

Condition or disease
Atrial Fibrillation

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

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Official Title: Variaciones En El Elctrocardiograma Como Prediccion Del Desarrollo De Fibrilacion AURIC
Study Start Date : July 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Atrial Fibrillation
Patients who develop atrial fibrillation
Non Atrial FIbrillation
Patients without atrial fibrillation

Primary Outcome Measures :
  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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients belonging to Health Plan Hospital Italiano de Buenos Aires active members who have ambulatory monitoring after the last follow-up ECG

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01405209

Hospital Italiano de Buenos AIres
Buenos Aires, Argentina
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Principal Investigator: Diego H Giunta, MD Hospital Italiano de Buenos Aires

Responsible Party: Diego Hernan Giunta, MD, MD, Hospital Italiano de Buenos Aires Identifier: NCT01405209     History of Changes
Other Study ID Numbers: 1713
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015

Keywords provided by Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires:

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes