PLUG Dementia Trial and MRI PLUG Dementia Sub-Study

NCT03091855 | Terminated

• 1 other identifier: 1050344
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Dementia; Cognitive Decline

Outcome Measures

Primary Outcomes (3)

• Dementia Incidence

  Incident dementia determined by a formal diagnosis by a neurologist.

  24 months

• Change in cognitive decline

  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.

  24 months

• Incidence of baseline micro- and macro-cerebral ischemic events (Sub-study Participants)

  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.

  24 months

Secondary Outcomes (1)

• Changes in cranial MRI

  24 months

Study Arms (2)

PLUG Dementia Trial

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.

Other: Questionnaire

MRI PLUG Dementia Sub-Study

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.

Diagnostic Test: Magnetic Resonance Imaging

Interventions

Questionnaire OTHER

Alzheimer's Disease Assessment Scale (ADAS-cog11) and Disability Assessment for Dementia (DAD) Questionnaires

PLUG Dementia Trial

Magnetic Resonance Imaging DIAGNOSTIC_TEST

MRI at baseline and at 24 months post-enrollment for 20 sub-study participants

MRI PLUG Dementia Sub-Study

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with atrial fibrillation that undergo a standard of care, clinically approved, left atrial appendage closure will be considered for study.

You may qualify if:

• Male or female \>65 years of age
• Atrial fibrillation documented by electrocardiogram, ambulatory event monitor, or telemetry within 6 months of enrollment
• Moderate risk of thromboembolism based upon a CHADS2 score or CHADS2 Vasc score of ≥2.
• 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)
• Have the ability to complete a mini-mental status evaluation
• Have the ability to independently comprehend and complete a quality of life and dementia questionnaires.
• Ability to provide informed consent for study participation
• Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

You may not qualify if:

• Have a history of any form of dementia
• Have a life expectancy less than 24 months
• Are unable to comply with the follow-up schedule
• Participation in any other clinical trials involving an investigational or marketed drug within 30 days prior to entry in this study;
• 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
• The Principal Investigator(s) determine(s) that the subject is not eligible for participation in this research study.
• Does not receive a left atrial appendage closure device
• Has contraindication towards the MRI scan (presence of a nonconditional cardiac implantable device, a history of metallic implants, shrapnel, neurosurgical clip placement)
• Has conditional cardiac MRI cardiac implantable device, joint replacements, coronary stents, ASD/PFO closure devices, sternal wires or most prosthetic heart valves
• Has severe renal dysfunction, defined as a creatinine clearance \<15 mL/min (documented within the last 3 months)

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Heart Institute

Murray, Utah, 84143, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Dementia; Cognitive Dysfunction

Interventions

Surveys and Questionnaires; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 27, 2017
• Study Start: April 3, 2017
• Primary Completion: January 8, 2021
• Study Completion: January 8, 2021
• Last Updated: April 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)