Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Colorado Cardiac Alliance | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Objectives:
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.
Inclusion Criteria
Method of Recruitment
Patients may also be phone consented and complete the testing at home via web-based testing.
• Patients of CSC with a known history of AF with be contacted with information on the study. If the patient is interested and have had >3 documented episodes of AF over the preceding 12 months they will be invited to pre-enroll in the study with the intention of having the subject already enrolled in the study before their next episode of AF.
Procedure:
The study involves an observational study design. Before the study begins:
• All nursing and study personnel participating in the study will undergo routine in-service notification/training about the study.
After the study is open:
Number of Subjects Previous similar studies suggest various findings for their effect size11. However, all the findings have been consistently supporting association between atrial fibrillation and cognitive impairment. Based upon a power of 80% and alpha of 0.05, most of the studies suggesting a need of over 250 subjects (98-472), therefore up to 600 subjects will be recruited in this study with a goal of obtaining data on at least 250 participants.
PROCEDURES TO MINIMIZE RISKS To minimize risks associated with breach of confidentiality all data will be entered into Centura work stations where clinicians enter patient data into the Electronic Medical Record (EMR), which is the patient's clinical record, that includes firewall and password protection. Data pertinent to this study will be transferred to a Centura Health password protected computer in a non-identifiable manner. All identifiable data will be kept in a key protected room only accessible by the research staff.
To minimize risks associated with psychological discomfort as a result of taking the Cambridge Cognition test or its results, breaks will be given where appropriate and the patient will be reminded frequently that they may stop the test at any time should they feel uncomfortable.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David R Brunk, PA-C, MMS | Common Spirit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penrose St. Francis | Colorado Springs | Colorado | 80907 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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). | ||
| 30703530 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 16818816 | 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. |
| 27547248 | 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. |
| 9040682 | 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. |
| 21806558 | 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. |
| 22371515 | 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. |
| 26988962 | 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. |
| 18667399 | 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. |
| 23460057 | 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. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D019954 | Neurobehavioral Manifestations |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D004554 | Electric Countershock |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
Not provided
Not provided