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PLUG Dementia Trial and MRI PLUG Dementia Sub-Study

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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.

Tracking Information
First Submitted Date March 15, 2017
First Posted Date March 27, 2017
Last Update Posted Date August 21, 2019
Actual Study Start Date April 3, 2017
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2019)
  • Dementia Incidence [ Time Frame: 24 months ]
    Incident dementia determined by a formal diagnosis by a neurologist.
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: March 24, 2017)
  • Dementia Incidence [ Time Frame: 24 months ]
    Incident dementia determined by a formal diagnosis by a neurologist.
  • 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.
Change History Complete list of historical versions of study NCT03091855 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 16, 2018)
Changes in cranial MRI [ Time Frame: 24 months ]
Incidence of bleeding and/or clots in the brain.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PLUG Dementia Trial and MRI PLUG Dementia Sub-Study
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)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Atrial Fibrillation
  • Dementia
  • Cognitive Decline
Intervention
  • Other: Questionnaire
    Alzheimer's Disease Assessment Scale (ADAS-cog11) and Disability Assessment for Dementia (DAD) Questionnaires
  • Diagnostic Test: Magnetic Resonance Imaging
    MRI at baseline and at 24 months post-enrollment for 20 sub-study participants
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Diagnostic Test: Magnetic Resonance Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 20, 2019)
60
Original Estimated Enrollment
 (submitted: March 24, 2017)
80
Estimated Study Completion Date October 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Patti Spencer 801-507-4778 patti.spencer@imail.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03091855
Other Study ID Numbers 1050344
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Intermountain Health Care, Inc.
Study Sponsor Intermountain Health Care, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Intermountain Health Care, Inc.
Verification Date August 2019