Atrial Fibrillation, Cognitive Decline, Dementia
Conditions
Brief summary
PLUG Dementia Trial: Patients will be screened at Intermountain Medical Center and at Intermountain affiliated anticoagulation clinics in the Salt Lake City region. Patients with atrial fibrillation that undergo a standard of care, clinically approved, left atrial appendage closure will be considered for study. All patients will be followed for 24 months, and will be assessed at the 3-, 6-, 12-, 18- and 24-months post-left atrial appendage closure as well as other visits deemed necessary for clinical care. All subjects will undergo protocol-specified laboratory tests and will complete 6 standard, validated questionnaires at each follow-up visit, except at the 3-month visit when only one questionnaire will be administered. A subset of patients (n=20), will receive a cranial MRI at baseline and 24-month visit. MRI PLUG Dementia Sub-Study: In addition to the above, 20 of the 60 subjects who are selected for participation in this sub-study will receive a cranial MRI at baseline and at the 2-year (24 months) follow-up visit.
Interventions
OTHERQuestionnaire
Alzheimer's Disease Assessment Scale (ADAS-cog11) and Disability Assessment for Dementia (DAD) Questionnaires
DIAGNOSTIC_TESTMagnetic Resonance Imaging
MRI at baseline and at 24 months post-enrollment for 20 sub-study participants
Sponsors
Intermountain Health Care, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female \>65 years of age 2. Atrial fibrillation documented by electrocardiogram, ambulatory event monitor, or telemetry within 6 months of enrollment 3. Moderate risk of thromboembolism based upon a CHADS2 score or CHADS2 Vasc score of ≥2. 4. Recipient of a left atrial appendage closure device within 3 months of enrollment (within 6 months, for patients considered for the MRI PLUG Dementia Sub-Study) 5. Have the ability to complete a mini-mental status evaluation 6. Have the ability to independently comprehend and complete a quality of life and dementia questionnaires. 7. Ability to provide informed consent for study participation 8. Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
Exclusion criteria
1. Have a history of any form of dementia 2. Have a life expectancy less than 24 months 3. Are unable to comply with the follow-up schedule 4. An upper age limit not to be used if participation inclusion criteria are met. 5. Participation in any other clinical trials involving an investigational or marketed drug within 30 days prior to entry in this study; 6. Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial 7. The Principal Investigator(s) determine(s) that the subject is not eligible for participation in this research study. In addition to the above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dementia Incidence | 24 months | Incident dementia determined by a formal diagnosis by a neurologist. |
| Change in cognitive decline | 24 months | Moderate cognitive decline defined as a 30% decrease in Alzheimer's Disease Assessment Scale score or those with a score \<50% or a 30% change on the Disability Assessment for Dementia. |
| Incidence of baseline micro- and macro-cerebral ischemic events (Sub-study Participants) | 24 months | assess the incidence of baseline micro- and macro-cerebral ischemic events (both bleeds and clots) at the time of left atrial appendage closure and compare this with a serial study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in cranial MRI | 24 months | Incidence of bleeding and/or clots in the brain. |
Countries
United States
Outcome results
None listed