Atrial Fibrillation/Flutter Outcome Risk Determination

NCT01138644 | Completed

• 2 other identifiers: The "AFFORD" StudyNHLBI
• Study Type: observational
• Target: 519
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Atrial Flutter

Keywords

Atrial Fibrillation; Atrial Flutter

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Patient death from any causes

  30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center - Emergency Medicine

Nashville, Tennessee, 37232-4700, United States

Location

Related Publications (4)

• 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.

  PMID: 21820279 BACKGROUND

• 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.

  PMID: 25633190 RESULT

• 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.

  PMID: 25245277 RESULT

• 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.

  PMID: 26920668 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood for storing and conducting genetic testing.

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tyler W Barrett, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine MD, MSCI

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 7, 2010
• Study Start: June 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2015
• Last Updated: April 29, 2015

Record last verified: 2015-04

Locations

US (1)