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
  Purpose

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.


Condition
Adults Past 18years Old With Two Electrocardiogram

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Variaciones En El Elctrocardiograma Como Prediccion Del Desarrollo De Fibrilacion AURIC

Resource links provided by NLM:


Further study details as provided by Hospital Italiano de Buenos Aires:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: July 2011
Groups/Cohorts
Atrial Fibrillation
Patients who develop atrial fibrillation
Non Atrial FIbrillation
Patients without atrial fibrillation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405209

Contacts
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

Locations
Argentina
Hospital Italiano de Buenos AIres Not yet recruiting
Buenos Aires, Argentina
Contact: Diego h Giunta, md    5411-49590200 ext 4419    diego.giunta@hospitalitaliano.org.ar   
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
  More Information

No publications provided

Responsible Party: Giunta DIego, HIBA
ClinicalTrials.gov Identifier: NCT01405209     History of Changes
Other Study ID Numbers: 1713
Study First Received: July 28, 2011
Last Updated: July 28, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Hospital Italiano de Buenos Aires:
EKG
AF
biosignals

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

ClinicalTrials.gov processed this record on July 22, 2014