Electrocardiogram Variations in the Prediction of Development of Atrial Fibrillation (EKG)
Recruitment status was Not yet recruiting
|First Received Date ICMJE||July 28, 2011|
|Last Updated Date||July 28, 2011|
|Start Date ICMJE||July 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Electrocardiogram Variations in the Prediction of Development of Atrial Fibrillation|
|Official Title ICMJE||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 . 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  (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 . 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 . 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.
|Detailed Description||Not Provided|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||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
|Condition ICMJE||Adults Past 18years Old With Two Electrocardiogram|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||100|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
1. Patients over 18 years Health Plan members of the Italian Hospital of Buenos Aires with at least 2 ECG separated .
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||Argentina|
|Removed Location Countries|
|NCT Number ICMJE||NCT01405209|
|Other Study ID Numbers ICMJE||1713|
|Has Data Monitoring Committee||No|
|Responsible Party||Giunta DIego, HIBA|
|Study Sponsor ICMJE||Hospital Italiano de Buenos Aires|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||Hospital Italiano de Buenos Aires|
|Verification Date||December 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP