- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01405209
Electrocardiogram Variations in the Prediction of Development of Atrial Fibrillation (EKG)
Variaciones En El Elctrocardiograma Como Prediccion Del Desarrollo De Fibrilacion AURIC
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Buenos Aires, Argentina
- Hospital Italiano de Buenos Aires
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
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Atrial Fibrillation
Patients who develop atrial fibrillation
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Non Atrial FIbrillation
Patients without atrial fibrillation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Variations (differences or deltas) between 2 standard ECG separated in time
Time Frame: at least 20 days after the first ekg
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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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at least 20 days after the first ekg
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1713
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