Neurologic Injury AAR: Neurologic Injury Following Aortic Arch Replacement: A Comparison of Two Different Cerebral Protection Strategies (A Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Rate of Neurologic Injury assessed by Magnetic Resonance Imaging (MRI)
研究概览
简要总结
Investigators are seeking to learn how well different cooling temperatures along with different blood flow pathways to the brain reduce the risk of injury to the brain in participants planning to undergo elective aortic arch and hemiarch surgery. Participants will be randomized to receive a cerebral protection strategy of either: deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP) or moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP). Evidence of neurologic injury will be assessed with neurologic exams, neurocognitive tests, MRI imaging of the brain and measurement of plasma S-100 levels during post operative follow ups.
详细描述
The purpose of this study is to investigate the impact of the two most commonly employed methods of cerebral protection upon mitigating neurologic injury in participants planning to undergo elective aortic arch and hemiarch surgery. Participants will be recruited from patients undergoing ascending aortic and hemiarch replacement using hypothermic circulatory arrest at Emory University Hospital and Emory Saint Joseph's Hospital. Participants will be randomized to receive a cerebral protection strategy of either: deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP) or moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP). Evidence of neurologic injury will be assessed with neurologic exams, neurocognitive tests, MRI imaging of the brain and measurement of plasma S-100 levels during post operative follow up. Follow up visits will be conducted at Days 1, 3, 7, and 180 post operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at Emory University Hospital and Emory Saint Joseph's Hospital planning to undergo:
- •Elective surgical replacement of the ascending aorta and proximal ("hemiarch") using hypothermic circulatory arrest
- •Concomitant cardiac procedures (e.g valve replacement, coronary artery bypass, etc.) in addition to ascending aortic and hemiarch replacement
- •Any of the following cannulation and cerebral protection strategies:
- •Right axillary artery cannulation, deep hypothermic circulatory arrest, retrograde cerebral perfusion
- •Right axillary artery cannulation, moderate hypothermic circulatory arrest, unilateral selective antegrade cerebral perfusion
排除标准
- •Undergoing total arch replacement
- •Undergoing hemiarch replacement without the use of hypothermic circulatory arrest
- •Undergoing hemiarch replacement using hypothermic circulatory arrest with a method of cerebral protection not listed in the Eligibility Criteria.
- •Pregnant women or women who are nursing.
研究组 & 干预措施
DHCA+RCP
Participants undergoing ascending aortic and hemiarch replacement will receive deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP).
干预措施: DHCA+RCP (Procedure)
MHCA+uSACP
Participants undergoing ascending aortic and hemiarch replacement will receive moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP).
干预措施: MHCA + SACP (Procedure)
结局指标
主要结局
Rate of Neurologic Injury assessed by Magnetic Resonance Imaging (MRI)
时间窗: Duration of Study (Up to 180 days)
The number of participants with evidence of neurologic injury assessed by MRI.
Change in Verbal Memory Test Score
时间窗: Post Operative Visit Day 1, Post Operative Visit Day 180
The verbal memory test measures how many words participants can keep in short term memory at once. A higher score indicates better short term memory.
Incidence of Transient Ischemic Attack (TIA)
时间窗: Duration of Study (Up to 180 days)
The number of participants with a new focal neurologic symptom lasting less than 24 hours without radiographic evidence of infarction.
Change in Finger Tapping Test Score
时间窗: Post Operative Visit Day 1, Post Operative Visit Day 180
The finger-tapping test (FTT) is a neuropsychological test that examines motor functioning, specifically, motor speed and lateralized coordination. During administration, the participant's palm should be immobile and flat on the board, with fingers extended, and the index finder placed on the counting device. One hand at a time, participants tap their index finger on the lever as quickly as possible within a 10-s time interval, in order to increase the number on the counting device with each tap.
Change in Continuous Performance Test Score
时间窗: Post Operative Visit Day 1, Post Operative Visit Day 180
The continuous performance test measures a participant's sustained and selective attention. Sustained attention is the ability to maintain a consistent focus on some continuous activity or stimuli, and is associated with impulsivity. Selective attention is the ability to focus on relevant stimuli and ignore competing stimuli. This skill is associated with distractibility.\[1\]
Change in Shifting Attention Test Score
时间窗: Post Operative Visit Day 1, Post Operative Visit Day 180
The Shifting Attention Test measures a participant's executive functions (rules, categories, rapid decision making) or their ability to shift from one instruction set to another quickly and accurately.
Change in Visual Memory Test Score
时间窗: Post Operative Visit Day 1, Post Operative Visit Day 180
The visual memory test measures how many items a participant can keep in short term memory at once. A higher score indicates better short term memory.
Change in Symbol Digit Coding Score
时间窗: Post Operative Visit Day 1, Post Operative Visit Day 180
The Digit symbol substitution test (DSST) is a neuropsychological test sensitive to brain damage, dementia, age and depression. It consists of nine digit-symbol pairs followed by a list of digits.Under each digit the participant should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.
Change in Stroop Test Score
时间窗: Post Operative Visit Day 1, Post Operative Visit Day 180
The Stroop effect is a demonstration of interference in the reaction time of a task. Participants will be asked the name of a color printed in a color not denoted by the name. Naming the color of the word takes longer and is more prone to errors than when the color of the ink matches the name of the color.
Incidence of Stroke
时间窗: Duration of Study (Up to 180 days)
The number of participants with a new focal neurologic deficit lasting greater than 24 hours that is confirmed by radiographic evidence of infarction.
次要结局
- Incidence of Temporary Neurologic Deficit (TND)(Duration of Study (Up to 180 days))
- Change in Serum S-100 Levels(Post Operative Visit Day 1, Post Operative Visit Day 180)
研究者
Bradley Leshnower
Assistant Professor
Emory University