Acute Cognitive Changes During Atrial Fibrillation Episodes (AFCOG) (AFCOG)

September 11, 2023 updated by: David Brunk

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Inclusion Criteria

  • Subjects who are patients at Colorado Springs Cardiology (CSC) or Penrose-St. Francis Health Services.
  • Patients who are between 35-80 years of age.
  • Subjects actively in an episode of paroxysmal, or persistent AF (who are expected to receive treatment and converted back to sinus rhythm (through antiarrhythmic drug therapy, direct current cardioversion, ablation or Maze/Minimally invasive Maze procedure).
  • Subjects with a history of AF who have had >3 documented episodes of AF over the preceding 12 months and meet all other inclusion/exclusion criteria can pre-enroll. The cognition tests will be administered during the patient's next captured AF episode.

Method of Recruitment

  • Study participants will be recruited after it is determined that they are acutely in an episode of AF by a standard of care 12-lead EKG (or KardiaApp), during an outpatient clinical visit (established patient clinical visits, consultations, or new patient visits) at CSC, or when being consulted on or rounded on at Penrose Hospital or St. Francis Medical Center.
  • A baseline 12 lead EKG (or KardiaApp) at recruitment will establish or confirm the presence of AF
  • The research personnel will review the consent for the study with the patient while they are in the CSC office or the patient's room if they are recruited during their time admitted to Penrose-St. Francis Health Services. After the patient has signed the consent, patient eligibility will be confirmed and the study process will continue.

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:

  • While a potential participant at CSC, Penrose Hospital, or St. Francis Medical Center, patients who are determined to be in an active episode of AF by 12 Lead EKG, will be informed about the research study by research personnel and if they are interested in participating, the research personnel will proceed with the informed consent. Alternatively, patients of CSC with a known history of AF will be sent information on the study. If they are interested and have had > 3 documented episodes of AF over the preceding 12 months they will be invited to pre-enroll in the study (even when in normal rhythm) with the intention of having the subject already enrolled in the study before their next episode of AF.
  • After receiving informed consent and confirming eligibility, patients will have vital signs performed according to standard of care and a history taken. The subject will then be asked to answer the Cambridge Cognition test while in AF. This can happen on the same date the informed consent is performed.
  • If a patient decides to drop out of the study after signing the consent form routine clinical care will be followed.
  • The Cambridge Cognition test will be performed again at any point after 5 days from the termination of the AF episode after a 12 lead EKG confirms that they are no longer in AF (including after spontaneous conversion, pharmacologic cardioversion, electrical cardioversion, ablation or Maze procedure).
  • The results of each subject's cognitive testing while in an acute episode of AF (experimental) will be compared to the results of the same subject's results in normal rhythm (control).
  • Should a patient's AF episode not resolve within 6 months' time of the documented AF episode on the EKG the patient will be screen-failed and exited from the study without having taken the follow-up cognition test. All data collected prior to the subject exit will be kept for data analysis.

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Penrose St. Francis
        • Principal Investigator:
          • Christopher R Cole, MD
        • Principal Investigator:
          • Diana Adkins, BSN
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

  • 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).
  • Subjects with a history of AF who have had >3 documented episodes of AF over the preceding 12 months and meet all other inclusion/exclusion criteria can pre-enroll. The cognition tests will be administered during the patient's next captured AF episode.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Direct current cardioversion, PVAI-atrial fibrillation ablation, Minimally Invasive Surgical Maze procedure, Medications
Other Names:
  • Direct current cardioversion, PVAI, Minimally Invasive Surgical Maze, Medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Cognitive Score in Atrial Fibrillation compared to Normal Rhythm
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Brunk

Collaborators

Colorado Cardiac Alliance

Investigators

  • Principal Investigator: David R Brunk, PA-C, MMS, Centura Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2019

Primary Completion (Estimated)

July 24, 2026

Study Completion (Estimated)

July 24, 2026

Study Registration Dates

First Submitted

July 24, 2019

First Submitted That Met QC Criteria

July 24, 2019

First Posted (Actual)

July 26, 2019

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1416701

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Impairment

Clinical Trials on Standard of Care Interventions to convert patient from atrial fibrillation to normal rhythm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe