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NCT03091855 · ClinicalTrials.gov registry record
PLUG Dementia Trial and MRI PLUG Dementia Sub-Study
A clinical trial, sponsored by Intermountain Health Care.
- Terminated
- Registry status
- 22
- Enrollment target
NCT03091855: Clinical Trial study, sponsored by Intermountain Health Care.
NCT03091855 is a clinical trial that was terminated before completion, run by Intermountain Health Care. The registered enrollment target is 22 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03091855 was terminated before completion, sponsored by Intermountain Health Care.
- TERMINATED
- Registry status
- 22 participants
- Enrollment target
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.
Primary Outcome
Incident dementia determined by a formal diagnosis by a neurologist.
Interventions
- DIAGNOSTIC_TEST Magnetic Resonance Imaging
- OTHER Questionnaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2017-04-03 |
| Est. Completion | 2021-01-08 |
Why NCT03091855 stopped before completion
NCT03091855 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 22 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Magnetic Resonance Imaging is the first listed.
NCT03091855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03091855 about?
NCT03091855 is a clinical study titled "PLUG Dementia Trial and MRI PLUG Dementia Sub-Study". 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 consider...
What is the current status of trial NCT03091855?
This trial is currently terminated. The enrollment target is 22 participants. The study started on 2017-04-03. Estimated completion is 2021-01-08.
What interventions are being tested in trial NCT03091855?
The interventions under investigation include: Magnetic Resonance Imaging (DIAGNOSTIC_TEST), Questionnaire (OTHER).
Who is sponsoring clinical trial NCT03091855?
This trial is sponsored by Intermountain Health Care, which has 85 total clinical trials registered on ClinicalTrials.gov.
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