Atrial Fibrillation/Flutter Outcome Risk Determination (AFFORD)
It is our hypotheses that 1) readily available Emergency Department data can be utilized in an Atrial Fibrillation clinical prediction rule to identify those patients at low or high risk for adverse outcomes; 2) Assigned risk can be utilized to drive physician decision-making by identifying patients who do not require hospital admission (low risk) and patients needing hospitalization (high risk); and 3) a facile version of the AFPR will be easily incorporated into standard Emergency Department patient management systems and assist physicians with risk stratification of patients presenting with Atrial Fibrillation.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||The "AFFORD" Study: Atrial Fibrillation/Flutter Outcome Risk Determination|
- 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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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
whole blood for storing and conducting genetic testing.
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138644
|United States, Tennessee|
|Vanderbilt University Medical Center - Emergency Medicine|
|Nashville, Tennessee, United States, 37232-4700|
|Principal Investigator:||Tyler W Barrett, MD||Vanderbilt University|