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)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Dementia Incidence
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •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.
排除标准
- •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
- •An upper age limit not to be used if participation inclusion criteria are met.
- •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.
- •In addition to the above exclusion criteria, patients considered for the MRI PLUG Dementia Sub-Study will be excluded if the patient -
- •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)
结局指标
主要结局
Dementia Incidence
时间窗: 24 months
Incident dementia determined by a formal diagnosis by a neurologist.
Incidence of baseline micro- and macro-cerebral ischemic events (Sub-study Participants)
时间窗: 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.
Change in cognitive decline
时间窗: 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.
次要结局
- Changes in cranial MRI(24 months)