Complications of Atrial Fibrillation Clinical Trial
Official title:
New Causes and Predictors for the Development of Atrial Fibrillation and Its Complications
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and its prevalence
increases with aging of the population. It is reflected in the ECG recording by the
replacement of regular P-waves by an undulating baseline and irregular ventricular complexes
[2]. The uncoordinated atrial activity prevents effective atrial contraction, leading to
clot formation. Atrial fibrillation contributes significantly to population morbidity and
mortality, and presently available therapeutic approaches have major limitations, including
limited efficacy and potentially serious side effects. It can be classified into one of the
three following categories:
1. Paroxysmal: self-termination within 7 days
2. Persistent: requires termination by pharmacological or direct-current electric
cardioversion
3. Permanent: restoration to sinus rhythm is impossible or inadvisable
It is believed that in many cases the natural history of AF involves evolution from
paroxysmal to persistent to permanent forms through the influence of atrial remodeling
caused by the arrhythmia itself and/or progression of underlying heart disease. As many
underlying conditions contribute to the development and progression of AF, the full and
exact mechanisms standing behind this common arrhythmia are not completely or sufficiently
understood.
Thromboembolism is by far the most important complication of AF, and the most common factor
in stroke in the elderly. The determinants of Virchow triad, including stasis, endothelial
damage, and coagulation properties, are centrally involved in AF- related thrombus
formation.
Hence, thorough searching for new possible causes or contributing factors for the developing
and progression of AF and its most threatening complication, thromboembolism, is mandatory
The aim of the study is to look for new possible causes of atrial fibrillation and its
complications.
| Status | Completed |
| Enrollment | 500 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - primary diagnosis with Acute Atrial Fibrillation - 18 years old or older at the time of diagnosis - admitted between 1.1.2007 and 31.12.2011 Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Rambam Health Care Campus |
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Dobrev D, Nattel S. New antiarrhythmic drugs for treatment of atrial fibrillation. Lancet. 2010 Apr 3;375(9721):1212-23. doi: 10.1016/S0140-6736(10)60096-7. Epub 2010 Mar 22. Review. — View Citation
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Nattel S, Opie LH. Controversies in atrial fibrillation. Lancet. 2006 Jan 21;367(9506):262-72. Review. — View Citation
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Watson T, Shantsila E, Lip GY. Mechanisms of thrombogenesis in atrial fibrillation: Virchow's triad revisited. Lancet. 2009 Jan 10;373(9658):155-66. doi: 10.1016/S0140-6736(09)60040-4. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Readmission due to Atrial Fibrillation | 3 years | No | |
| Secondary | Developement of stroke or transient ischemic attack, Developement of Congestive heart failure and Death | 3 years | No |