Genomic and Biomarker Predictors of Acute Kidney Injury and Other Post-Procedural Outcomes Following Transcatheter Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 3
- 主要终点
- Acute Kidney Injury using KDIGO criteria
研究概览
简要总结
In the last decade, transcatheter aortic valve replacement (TAVR) has become an increasingly utilized alternative procedure for replacing a stenotic aortic valve. This study collects clinical information, DNA, blood and urine samples (throughout procedural hospitalization) in order to investigate the incidence of acute kidney injury (AKI) in patients undergoing TAVR and to identify key clinical and procedural predictors of AKI. This study seeks to identify blood and urine biomarkers that can be used for early detection of AKI around the time of the procedure. The study seeks to assess for novel genetic variants associated with development of AKI after TAVR. Finally the study seeks to assess for novel genetic variants and biomarkers that are associated with adverse cardiovascular events after TAVR and to further explore how these events may inter-relate with acute kidney injury.
详细描述
This study enrolls patients who have aortic stenosis who undergo TAVR at the University of Texas Southwestern Medical Center University Hospital. Development of post-TAVR AKI defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) SCr based criteria will be ascertained. Patients will be followed during primary hospitalization and during the 5 years following TAVR for adverse kidney outcomes as well as potentially related adverse cardiovascular outcomes. Clinical and procedural data is collected for each study patient. All subjects will have paired blood and urine collection done pre-TAVR, 6 hours after aortic valve prosthesis deployment, and on post-procedure days 1 and 2. Subjects who develop AKI will also have paired blood and urine samples collected on days 3, 4 and 5. Patients receive follow-up questionnaires by mail or email asking about hospitalizations as well as visits to cardiology, nephrology and primary care physicians. Questionnaires will also ask about health-related quality of life using validated study questionnaires. Patient follow-up will occur at regular intervals until 5 years after TAVR procedure.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •The patient cannot or will not provide informed consent.
- •The patient is aged less than 18 years.
- •The patient's pre-procedural hematocrit is less than 25%.
- •The patient has known human immunodeficiency virus infection
- •The patient has known hepatitis C that has not been treated with antiviral medications
- •In the opinion of the principal investigator, the patient will be unlikely to complete long-term follow up for medical or social reasons (this includes transient patients and patients who have no fixed address).
结局指标
主要结局
Acute Kidney Injury using KDIGO criteria
时间窗: Day of procedure to post procedure day 5
Data will be collected from electronic medical records; data points to be collected for this measurement include serum creatinine
次要结局
- Need for dialysis (e.g. number of participants who undergo post-procedural dialysis)(Day of procedure to year 5)
- Heart failure per NYHA class II, III, IV(Day of procedure to year 5)
- Vascular complications (i.e. number of participants who develop arterial injury, dissection, limb ischemia during postoperative day 0 up to year 5)(Day of procedure to year 5)
- Mortality (i.e. number of participants who are deceased during postoperative day 0 up to year 5)(Day of procedure to year 5)
- SAQ Quality of Life Survey(Administered once prior to the procedure and 1 month to 5 years after hospital discharge)
- KCCQ Quality of Life Survey(Administered once prior to the procedure and 1 month to 5 years after hospital discharge)
- Chronic renal insufficiency (i.e. number of patients that will have received a diagnosis of chronic renal insufficiency)(Day of procedure to year 5)
- Presence of Arrhythmia (i.e. number of patients who develop an arrhythmia from postoperative day 0 to 5 years).(Day of procedure to year 5)
- Myocardial Infarction (i.e. number of participants who develop a MI during postoperative day 0 to year 5)(Day of procedure to year 5)
- Cerebrovascular accident (i.e. number of participants who develop transient ischemic attack or permanent stroke during postoperative day 0 up to 5 years)(Day of procedure to year 5)
- SF12 Quality of Life Survey(Administered once prior to the procedure and 1 month to 5 years after hospital discharge)
研究者
Amanda A Fox, MD, MPH
Professor of Anesthesiology
University of Texas Southwestern Medical Center