Atrial Fibrillation/Flutter Outcome Risk Determination

NCT ID: NCT01138644

Last Updated: 2015-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

519 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrial Fibrillation Atrial Flutter

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Tyler Barrett

Assistant Professor of Emergency Medicine MD, MSCI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tyler W Barrett, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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Vanderbilt University Medical Center - Emergency Medicine

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21820279 (View on PubMed)

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.

Reference Type RESULT
PMID: 25633190 (View on PubMed)

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.

Reference Type RESULT
PMID: 25245277 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26920668 (View on PubMed)

Other Identifiers

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NHLBI

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

The "AFFORD" Study

Identifier Type: -

Identifier Source: org_study_id

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