Acute Cognitive Changes During Atrial Fibrillation Episodes (AFCOG)

NCT04033510 | Active Not Recruiting

• 1 other identifier: 1416701
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives:

• First, to determine if patients with a history of AF have acute measurable changes in cognitive functioning while in an episode of AF.
• Second, to collect basic insight into what specific physiologic (blood pressure, pulse oximetry, heart rate, temperature) and pharmacologic (antiarrhythmic medications, rate control medications, anticoagulants, antiplatelet medications, etc.) factors minimize the neurological impact on patients while they are in AF. It is hypothesized that when using a tablet-based cognitive testing software - Cambridge Cognition (specifically to assess executive function, learning and working memory: Rapid Visual Information Processing test, Spatial Working Memory/Spatial Span Task tests, One touch Stockings of Cambridge test, Cambridge Gambling Task, Multitasking Test/Intra-Extra Dimensional Set shift tests) - a significant difference will be noted between how the patients perform while in atrial fibrillation compared to the patients' performance while in normal sinus rhythm.

Conditions

Atrial Fibrillation; Cognitive Symptom; Executive Dysfunction; Cognitive Change; Cognitive Impairment; Cognitive Impairment, Mild

Keywords

atrial fibrillation; cognitive symptoms; executive dysfunction; cognitive change; cognitive impairment; tablet-based cognitive evaluation; Cambridge Cognition; CANTAB; Afib

Outcome Measures

Primary Outcomes (1)

• Difference in Cognitive Score in Atrial Fibrillation compared to Normal Rhythm

  Cognitive score determined by Cambridge Cognition tablet-based cognitive testing software (CANTAB), determining if there is a significant difference between subjects in atrial fibrillation as compared to when those same subjects are in normal rhythm.

  While in atrial fibrillation with the intention of regaining normal rhythm either through spontaneous, pharmacologic, direct current cardioversion, atrial fibrillation catheter ablation (PVAI), or Maze procedure.

Study Arms (1)

AF/NR

Single cohort with a known or new diagnosis of atrial fibrillation, and intention attain/maintain normal rhythm. Subjects with be their own controls: Tablet-based cognitive testing to be performed while in atrial fibrillation (AF), and while they are in normal rhythm (NR). Results of both sets of cognitive testing will be compared.

Other: Standard of Care Interventions to convert patient from atrial fibrillation to normal rhythm

Interventions

Standard of Care Interventions to convert patient from atrial fibrillation to normal rhythm OTHER

Direct current cardioversion, PVAI-atrial fibrillation ablation, Minimally Invasive Surgical Maze procedure, Medications

Also known as: Direct current cardioversion, PVAI, Minimally Invasive Surgical Maze, Medications

AF/NR

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of Colorado Springs Cardiology: A Centura Health Clinic (CSC) with a history of, or new diagnosis of, Atrial fibrillation with the intention of being converted back to normal rhythm.

You may qualify if:

• Subjects who are patients at CSC or Penrose-St. Francis Health Services.
• Subjects actively in an episode of paroxysmal, or persistent AF (who are expected to receive treatment and converted back to normal rhythm (through antiarrhythmic drug therapy, direct current cardioversion, ablation or Maze/Minimally invasive Maze procedure).

You may not qualify if:

• Patients who had coronary bypass surgery during their life time.
• Patients with a previously documented history of post-pump syndrome during their life time.
• Patients with presence of, or medical diagnosis of Transient Ischemic Attack (TIA) or Cerebral Vascular Accident (CVA).
• Patients with presence of, or medical diagnosis of cognitive impairment (dementia, multiple sclerosis, traumatic brain injury, etc.).
• Female patients who are pregnant or post-partum.
• Individuals unwilling or unable to take an anticoagulant.

Sponsors & Collaborators

• David Brunk, PA-C, MMS: lead
• Colorado Cardiac Alliance: collaborator

Study Sites (1)

Penrose St. Francis

Colorado Springs, Colorado, 80907, United States

Location

Related Publications (11)

• What is Atrial Fibrillation? American Heart Association (2017). Retrieved from: http://www.heart.org/HEARTORG/Conditions/Arrhythmia/AboutArrhythmia/What-is-Atrial-Fibrillation-AFib-or-AF_UCM_423748_Article.jsp#.WuoR0aQvyUk on May, 2018.

  BACKGROUND

• Bajpai, A.; Savelieva, I.; Camm, AJ. Epidemiology AND Economic Burden of Atrial Fibrillation. Touch Briefings US Cardiovascular Disease (2007).

  BACKGROUND

• Writing Group Members; January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Heart Rhythm. 2019 Aug;16(8):e66-e93. doi: 10.1016/j.hrthm.2019.01.024. Epub 2019 Jan 28. No abstract available.

  PMID: 30703530 BACKGROUND

• Miyasaka Y, Barnes ME, Gersh BJ, Cha SS, Bailey KR, Abhayaratna WP, Seward JB, Tsang TS. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation. 2006 Jul 11;114(2):119-25. doi: 10.1161/CIRCULATIONAHA.105.595140. Epub 2006 Jul 3.

  PMID: 16818816 BACKGROUND

• Alonso A, Arenas de Larriva AP. Atrial Fibrillation, Cognitive Decline And Dementia. Eur Cardiol. 2016 Summer;11(1):49-53. doi: 10.15420/ecr.2016:13:2.

  PMID: 27547248 BACKGROUND

• Ott A, Breteler MM, de Bruyne MC, van Harskamp F, Grobbee DE, Hofman A. Atrial fibrillation and dementia in a population-based study. The Rotterdam Study. Stroke. 1997 Feb;28(2):316-21. doi: 10.1161/01.str.28.2.316.

  PMID: 9040682 BACKGROUND

• Dublin S, Anderson ML, Haneuse SJ, Heckbert SR, Crane PK, Breitner JC, McCormick W, Bowen JD, Teri L, McCurry SM, Larson EB. Atrial fibrillation and risk of dementia: a prospective cohort study. J Am Geriatr Soc. 2011 Aug;59(8):1369-75. doi: 10.1111/j.1532-5415.2011.03508.x. Epub 2011 Aug 1.

  PMID: 21806558 BACKGROUND

• Marzona I, O'Donnell M, Teo K, Gao P, Anderson C, Bosch J, Yusuf S. Increased risk of cognitive and functional decline in patients with atrial fibrillation: results of the ONTARGET and TRANSCEND studies. CMAJ. 2012 Apr 3;184(6):E329-36. doi: 10.1503/cmaj.111173. Epub 2012 Feb 27.

  PMID: 22371515 BACKGROUND

• Chen LY, Agarwal SK, Norby FL, Gottesman RF, Loehr LR, Soliman EZ, Mosley TH, Folsom AR, Coresh J, Alonso A. Persistent but not Paroxysmal Atrial Fibrillation Is Independently Associated With Lower Cognitive Function: ARIC Study. J Am Coll Cardiol. 2016 Mar 22;67(11):1379-80. doi: 10.1016/j.jacc.2015.11.064. No abstract available.

  PMID: 26988962 BACKGROUND

• Knecht S, Oelschlager C, Duning T, Lohmann H, Albers J, Stehling C, Heindel W, Breithardt G, Berger K, Ringelstein EB, Kirchhof P, Wersching H. Atrial fibrillation in stroke-free patients is associated with memory impairment and hippocampal atrophy. Eur Heart J. 2008 Sep;29(17):2125-32. doi: 10.1093/eurheartj/ehn341. Epub 2008 Jul 29.

  PMID: 18667399 BACKGROUND

• Kalantarian S, Stern TA, Mansour M, Ruskin JN. Cognitive impairment associated with atrial fibrillation: a meta-analysis. Ann Intern Med. 2013 Mar 5;158(5 Pt 1):338-46. doi: 10.7326/0003-4819-158-5-201303050-00007.

  PMID: 23460057 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Neurobehavioral Manifestations; Cognitive Dysfunction

Interventions

Electric Countershock; Dosage Forms

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• David R Brunk, PA-C, MMS

  Common Spirit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 26, 2019
• Study Start: August 14, 2019
• Primary Completion: November 25, 2024
• Study Completion (Estimated): January 30, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)