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PLUG Dementia Trial and MRI PLUG Dementia Sub-Study

NCT03091855 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2021-04-05

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Intermountain Health Care, Inc.

    lead OTHER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2021-01-08
Completion
2021-01-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03091855 on ClinicalTrials.gov