Atrial Fibrillation/Flutter Outcome Risk Determination

Atrial Fibrillation Clinical Trial

— AFFORD  

Official title:

The "AFFORD" Study: Atrial Fibrillation/Flutter Outcome Risk Determination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138644
• Other study ID #: The "AFFORD" Study
• Secondary ID: NHLBI
• Status: Completed
• Phase: N/A
• First received: May 28, 2010
• Last updated: April 28, 2015
• Start date: June 2010
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 519
• Est. completion date: April 2015
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ED patients 18 years and older

• Provide informed consent

• Have a documented diagnosis of AF or atrial flutter on electrocardiogram or rhythm strip from an ED, prehospital provider or outside medical facility on day of enrollment.

• Present with signs (tachycardia, dyspnea) or symptoms (palpitations, chest pain, shortness of breath, weakness, lightheadedness, pre-syncope, or syncope) consistent with primary symptomatic AF

• Patients whose primary complaint is not directly related to their AF diagnosis (e.g. evaluation for febrile illness, gastrointestinal complaint, injury) BUT have a secondary complaint consistent with symptomatic AF that requires ED evaluation (e.g. new AF diagnosis, AF associated with inadequate rate control (defined as resting heart rate greater than 100bon), AF associated with heart failure symptoms, AF in the setting of CVA or TIA, AF associated with other thromboembolic complications).

Exclusion Criteria:

• Patients who are under the age of 18

• Previously enrolled patients

• ED patients who present with complaints unrelated to their AF (e.g. sprained ankle,pharyngitis) and have adequately rate (<100 bpm at rest) or rhythm controlled-AF.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center - Emergency Medicine	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Barrett TW, Jenkins CA, Self WH. Validation of the Risk Estimator Decision Aid for Atrial Fibrillation (RED-AF) for predicting 30-day adverse events in emergency department patients with atrial fibrillation. Ann Emerg Med. 2015 Jan;65(1):13-21.e3. doi: 10 — View Citation

Barrett TW, Storrow AB, Jenkins CA, Abraham RL, Liu D, Miller KF, Moser KM, Russ S, Roden DM, Harrell FE Jr, Darbar D. The AFFORD clinical decision aid to identify emergency department patients with atrial fibrillation at low risk for 30-day adverse event — View Citation

Barrett TW, Storrow AB, Jenkins CA, Harrell FE Jr, Miller KF, Moser KM, Russ S, Roden DM, Darbar D. Atrial fibrillation and flutter outcomes and risk determination (AFFORD): design and rationale. J Cardiol. 2011 Sep;58(2):124-30. doi: 10.1016/j.jjcc.2011.06.007. Epub 2011 Aug 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of an atrial-fibrillation or atrial flutter related adverse event at 5 days from the index 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.	5 days from ED visit	Yes
Primary	Incidence of an Atrial fibrillation or atrial flutter related adverse event within 30 days of index 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.	30 days from ED visit	Yes
Secondary	Patient death from any causes	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.	30 days	Yes