Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PLUG Dementia Trial and MRI PLUG Dementia Sub-Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03091855
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

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.


Condition or disease Intervention/treatment
Atrial Fibrillation Dementia Cognitive Decline Other: Questionnaire Diagnostic Test: Magnetic Resonance Imaging

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Overall and MRI-based Impact of Percutaneous Left Atrial Appendage Closure on the Cognitive Decline and Dementia in Patients With Atrial Fibrillation (PLUG Dementia Trial and MRI PLUG Dementia Sub-Study)
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Alzheimer's Disease Assessment Scale (ADAS-cog11) and Disability Assessment for Dementia (DAD) Questionnaires

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




Primary Outcome Measures :
  1. Dementia Incidence [ Time Frame: 24 months ]
    Incident dementia determined by a formal diagnosis by a neurologist.

  2. Change in cognitive decline [ Time Frame: 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.

  3. Incidence of baseline micro- and macro-cerebral ischemic events (Sub-study Participants) [ Time Frame: 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 Outcome Measures :
  1. Changes in cranial MRI [ Time Frame: 24 months ]
    Incidence of bleeding and/or clots in the brain.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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 exclusion criteria, patients considered for the MRI PLUG Dementia Sub-Study will be excluded if the patient -

  1. Does not receive a left atrial appendage closure device
  2. Has contraindication towards the MRI scan (presence of a nonconditional cardiac implantable device, a history of metallic implants, shrapnel, neurosurgical clip placement)
  3. Has conditional cardiac MRI cardiac implantable device, joint replacements, coronary stents, ASD/PFO closure devices, sternal wires or most prosthetic heart valves
  4. Has severe renal dysfunction, defined as a creatinine clearance <15 mL/min (documented within the last 3 months)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091855


Contacts
Layout table for location contacts
Contact: Patti Spencer 801-507-4778 patti.spencer@imail.org

Locations
Layout table for location information
United States, Utah
Intermountain Heart Institute Recruiting
Murray, Utah, United States, 84143
Contact: T Jared Bunch, MD    801-507-4701    jared.bunch@imail.org   
Contact: Patti Spencer    801-507-4778    patti.spencer@imail.org   
Sponsors and Collaborators
Intermountain Health Care, Inc.

Layout table for additonal information
Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT03091855     History of Changes
Other Study ID Numbers: 1050344
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Atrial Fibrillation
Cognitive Dysfunction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders