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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Hospital Italiano de Buenos Aires.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT01405209
First received: July 28, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted

July 28, 2011
July 28, 2011
July 2011
Not Provided
Variations (differences or deltas) between 2 standard ECG separated in time [ Time Frame: at least 20 days after the first ekg ] [ Designated as safety issue: No ]
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
Same as current
No Changes Posted
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Electrocardiogram Variations in the Prediction of Development of Atrial Fibrillation
Variaciones En El Elctrocardiograma Como Prediccion Del Desarrollo De Fibrilacion AURIC

Atrial fibrillation (AF) is the most common arrhythmia, affects 1% of adults and its prevalence increases with age [1]. 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 ECG [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, 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.

We propose 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.

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Observational
Observational Model: Cohort
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Non-Probability Sample

Adult patients belonging to Health Plan Hospital Italiano de Buenos Aires active members who have ambulatory monitoring after the last follow-up ECG

Adults Past 18years Old With Two Electrocardiogram
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  • Atrial Fibrillation
    Patients who develop atrial fibrillation
  • Non Atrial FIbrillation
    Patients without atrial fibrillation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
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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.
Both
18 Years and older
No
Contact: Diego H Giunta, MD 5411-49590200 ext 4419 diego.giunta@hospitalitaliano.org.ar
Contact: Maria L Posadas-MArtinez, md 5411-49590200 ext 4419 maria.posadas@hospitalitaliano.org.ar
Argentina
 
NCT01405209
1713
No
Giunta DIego, HIBA
Hospital Italiano de Buenos Aires
Not Provided
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Hospital Italiano de Buenos Aires
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP