Atrial Fibrillation/Flutter Outcome Risk Determination (AFFORD)
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|ClinicalTrials.gov Identifier: NCT01138644|
Recruitment Status : Completed
First Posted : June 7, 2010
Last Update Posted : April 29, 2015
|Condition or disease|
|Atrial Fibrillation Atrial Flutter|
AF: Impact on Present and Future National Health Over 2 million people in the United States have Atrial Fibrillation, the most common sustained arrhythmia.1 That number of patients is expected to increase to 5.6 million by 2050.1 Atrial Fibrillation is associated with a 4-5 fold increase in the risk of stroke, 3-fold increase in the risk of heart failure and 1.5-1.9 increased risk of death.2-6 The prevalence of Atrial Fibrillation increases as individuals age; 5.9% of those over 65 years of age and 9% of those over 80 years are diagnosed with the arrhythmia.25 The lifetime risk for development of Atrial Fibrillation is estimated to be 1 in 4 for men and women forty years of age and older.26 The proper management of patients with AF is critical due to the well-documented association with heart failure and stroke.2-6, 11, 27.
The number of Emergency Department visits for complaints related to Atrial Fibrillation increased by 88% between 1993 and 2003 and now account for approximately 1% percent of all Emergency Department visits in the United States.7, 24 More than 65% of these Atrial Fibrillation visits result in hospital admission and over $6.65 billion in expenditures, including $3.88 billion for hospitalizations, $1.53 billion for outpatient treatment and nearly $240 million for prescription drugs.8, 24 Patients with a primary admission diagnosis of AF had a mean length of stay and hospital charge of 4 days and $7000 in 1999.28 Over the past 20 years, the admission rate for Atrial Fibrillation has increased by 66%.29-31 The combination of increasing Atrial Fibrillation prevalence, unnecessarily high admission rate and Emergency Department crowding is likely to severely burden our healthcare system.
|Study Type :||Observational|
|Actual Enrollment :||519 participants|
|Official Title:||The "AFFORD" Study: Atrial Fibrillation/Flutter Outcome Risk Determination|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||April 2015|
- Incidence of an atrial-fibrillation or atrial flutter related adverse event at 5 days from the index ED visit. [ Time Frame: 5 days from ED visit ]We define adverse events as the following patient death, 5-day ED return visits and unscheduled hospital admissions for AF-related complaints, AF-related cardiovascular and thromboembolic complications.
- Incidence of an Atrial fibrillation or atrial flutter related adverse event within 30 days of index ED visit [ Time Frame: 30 days from ED visit ]We define adverse events as the following patient death, 30-day ED return visits and unscheduled hospital admissions for AF-related complaints, AF-related cardiovascular and thromboembolic complications.
- Patient death from any causes [ Time Frame: 30 days ]We will record patient deaths due to any cause within 30 days of their ED visit. Only deaths classified as having cardiovascular causes will be included in the development of the prediction rule.
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138644
|United States, Tennessee|
|Vanderbilt University Medical Center - Emergency Medicine|
|Nashville, Tennessee, United States, 37232-4700|
|Principal Investigator:||Tyler W Barrett, MD||Vanderbilt University|