Status:
ACTIVE_NOT_RECRUITING
Acute Cognitive Changes During Atrial Fibrillation Episodes (AFCOG)
Lead Sponsor:
David Brunk, PA-C, MMS
Collaborating Sponsors:
Colorado Cardiac Alliance
Conditions:
Atrial Fibrillation
Cognitive Symptom
Eligibility:
All Genders
35-80 years
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 speci...
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 ep...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 30 2027
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04033510
Start Date
August 14 2019
End Date
January 30 2027
Last Update
October 14 2025
Active Locations (1)
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1
Penrose St. Francis
Colorado Springs, Colorado, United States, 80907