Atrial Fibrillation/Flutter Outcome Risk Determination (AFFORD)

Study Description

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Brief 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.

Condition or disease
Atrial Fibrillation; Atrial Flutter

Detailed 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.

Study Design

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Study Type :	Observational
Actual Enrollment :	519 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
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

Groups and Cohorts

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Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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

whole blood for storing and conducting genetic testing.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Participants for this study will be those with AF who present to the ED for their care. This study population will come from all walks of life and will not exclude any one group, sex, ethnicity, etc.

Criteria

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.

Contacts and Locations

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Locations

United States, Tennessee
Vanderbilt University Medical Center - Emergency Medicine
Nashville, Tennessee, United States, 37232-4700

Sponsors and Collaborators

Vanderbilt University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	Tyler W Barrett, MD	Vanderbilt University

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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 events. Am J Cardiol. 2015 Mar 15;115(6):763-70. doi: 10.1016/j.amjcard.2014.12.036. Epub 2015 Jan 6.

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: 10.1016/j.annemergmed.2014.08.023. Epub 2014 Sep 20.

Other Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Barrett TW, Self WH, Darbar D, Jenkins CA, Wasserman BS, Kassim NA, Casner M, Shoemaker MB. Association of atrial fibrillation risk alleles and response to acute rate control therapy. Am J Emerg Med. 2016 Apr;34(4):735-40. doi: 10.1016/j.ajem.2016.01.034. Epub 2016 Feb 10.

Responsible Party:	Tyler Barrett, Assistant Professor of Emergency Medicine MD, MSCI, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT01138644 History of Changes
Other Study ID Numbers:	The "AFFORD" Study; NHLBI ( Other Grant/Funding Number: 1K23HL102069-01 )
First Posted:	June 7, 2010
Last Update Posted:	April 29, 2015
Last Verified:	April 2015

Keywords provided by Tyler Barrett, Vanderbilt University:

Atrial Fibrillation; Atrial Flutter

Additional relevant MeSH terms:

Atrial Fibrillation; Atrial Flutter; Arrhythmias, Cardiac	Heart Diseases; Cardiovascular Diseases; Pathologic Processes