New Causes and Predictors for the Development of Atrial Fibrillation and Its Complications

May 23, 2013 updated by: Rambam Health Care Campus

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.

Study Overview

Status

Completed

Conditions

Detailed Description

This is an observational historical prospective study. All patients admitted to the Rambam health care campus between 1.1.2007 and 31.11.2011 with the primary diagnosis with Acute Atrial Fibrillation and were 18 years old or older at the time of diagnosis, will be included in this historical prospective study.

Patients' demographic data, medical history, permanent medications, laboratory studies, electrocardiographic and echocardiographic reports will be collected from the radiologic information system; a computed medical registry.

After collecting the data, statistical analysis will be performed aiming to discover possible causes or predictors for atrial fibrillation development and the occurrence of its adverse complications, especially thromboembolism.

Study Type

Observational

Enrollment (Actual)

500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to the Rambam health care campus between 1.1.2007 and 31.12.2011 with the primary diagnosis with Acute Atrial Fibrillation and were 18 years old or older at the time of diagnosis, will be included in this historical prospective study

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Acute Atrial Fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Readmission due to Atrial Fibrillation
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Developement of stroke or transient ischemic attack, Developement of Congestive heart failure and Death
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 12, 2013

First Submitted That Met QC Criteria

May 23, 2013

First Posted (Estimate)

May 29, 2013

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 23, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMB-0514-12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Complications of Atrial Fibrillation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe