Neuropsychological and Advanced Neuroimaging Evaluation of the Impact of Cognitive Impairment in Conventional Aortic Valve Replacement Compared to the Transcatheter Implant
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change from baseline neuropsychological study at late period (one year) after treatment in both groups
研究概览
简要总结
OBJECTIVE: To evaluate changes in cognitive performance in the early postoperative (1 month) and late (1 year) postoperative period in patients undergoing aortic valve replacement (SVAo) with surgery (SVA_Q) or transcatheter aortic valve implant (TAVI), by neuropsychological study (NRP), structural Brain Magnetic Resonance (sMRI) and functional MRI (fMRI). The specific objectives are: (1) to compare the early and late clinical-functional consequences with NRP study in both groups; (2) to compare the occurrence of cerebral clinical events during follow-up; (3) to quantify and compare the appearance of silent lesions in the early postoperative period and late of SVAo with sMRI with respect to the baseline MRI in both groups; (4) study with fMRI changes in the activity and functional connectivity and correlate them with the NRP findings in all patients in the early and late phase in comparison with the basal MRI. METHODOLOGY: Prospective longitudinal, unicentric, nonrandomized cohort study of consecutive patients> 70 years, with indication for SVAo and intermediate and high surgical risk. One month before surgery will be performed an sMRI and fMRI and a baseline NRP study. One month after surgery, sMRI, fMRI and NRP study will be performed to assess the appearance of new lesions, as well as changes in cognitive performance with respect to baseline cognitive status. One year later, sMRI, fMRI and NRP study will be performed to assess changes in cognitive status with respect to baseline and early postoperative. Response variables: changes in cognitive performance measured by a Global Cognitive Impairment Index and in cognitive status (normal vs. Mild Cognitive Impairment vs Moderate Impairment), number, size and location of new silent brain lesions, cerebral vascular clinical events, and changes in advanced neuroimaging (image by diffusion tensor (DTI), resting-state fMRI) and its relationship with cognitive changes.
详细描述
Design: Prospective, single-center, longitudinal cohort study with consecutive inclusion of patients older than 70 years of intermediate or high surgical risk who present Aortic Stenoses (AoS) that requires Aortic Valve Replacement (AVS). Two groups will be compared based on the type of treatment received, surgical valve replacement (SVA_Q) or transcatheter aortic valve implantation (TAVI). The choice of treatment will be made according to medical criteria decided by the "heart team" in which clinical cardiologists, hemodynamics and cardiac surgeons participate who follow the recommendations of the European Society Cardiology (ESC / EACTS) 2017 Guidelines. However, only those patients susceptible to treatment with both techniques, will be included. The decision will be agreed with the patient. A complete neuropsychological study and structural and functional MRI will be carried out, one month prior to treatment and one month and year after the procedure. Throughout the study, clinical follow-up will be carried out with evaluation of the appearance of clinical cerebrovascular events.
Study investigators will record the following variables; Once the patient is assigned to treatment, a visit will be scheduled where the surgeon in the case of SVA_Q or the cardiologist in the case of TAVI will assess whether the patient meets the eligibility criteria for the study. If patient fullfill all inclusion and none of exclusion criteria, study investigators will request the Informed Consent.
Baseline clinical variables:
- Age and sex
- Vascular risk factors
- Dyspnea: Functional class (New York Heart Association)
- Chronic obstructive pulmonary disease
- Preoperative Renal Insufficiency
- EuroScore II scale score
- Barthel scale score
- MMSE. The NRP study and neuroimaging will be scheduled for a maximum of one month before the procedure
Intraoperative characteristics:
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
- 70 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of severe / symptomatic aortic stenosis with indication for elective Aortic Valve Replacement
- •patients with intermediate or high surgical risk evaluated by EuroScore II 3-10%, susceptible to be treated with both techniques
- •age> 70 years
排除标准
- •contraindication to perform an MRI
- •severe renal failure
- •severe psychiatric illnesses
- •Diagnosed dementia or Mini Mental State Examination (MMSE) <19/35 corrected for age and education
- •surgical reintervention
- •patients with preoperative comorbidities that condition difficulties for a one-year clinical follow-up
- •aortic surgery concomitant to AVS or other than coronary revascularization
结局指标
主要结局
Change from baseline neuropsychological study at late period (one year) after treatment in both groups
时间窗: The cognition will be evaluated in two different time frames; at baseline and late period (one year) after the procedures.
Compare the mean score in the cognitive status evaluated with the Neuropsychological study (using the Global Cognitive Impairment Index) in the baseline period and at one year after treatment between both treatment groups (SVA_Q or TAVI). To compute the Global Cognitive Impairment Index (IDCG), first the direct scores obtained in the different neuropsychological tests will be transformed into z scores according to the scales of the normal population and taking into account age and level of schooling. The different tests will be grouped into cognitive domains that have been identified as relevant to detect the cognitive vascular impairment (CVI) to obtain subscripts of speed, attention, memory, language, visuospatial capacity and executive functions. The IDCG will include an average of the different domains evaluated.
Change from baseline neuropsychological study at early period (one month) after treatment in both groups
时间窗: The cognition will be evaluated in two different time frames; at baseline and early period (one month) after the procedures.
Compare the mean score in the cognitive status evaluated with the Neuropsychological study (using the Global Cognitive Impairment Index) in the baseline period and at one month after treatment between both treatment groups (SVA_Q or TAVI). To compute the Global Cognitive Impairment Index (IDCG), first the direct scores obtained in the different neuropsychological tests will be transformed into z scores according to the scales of the normal population and taking into account age and level of schooling. The different tests will be grouped into cognitive domains that have been identified as relevant to detect the cognitive vascular impairment (CVI) to obtain subscripts of speed, attention, memory, language, visuospatial capacity and executive functions. The IDCG will include an average of the different domains evaluated.
Change from early period (one month) neuropsychological study at late period (one year) after treatment in both groups
时间窗: The cognition will be evaluated in two different time frames; early period (one month) and late period (one year) after the procedures.
Compare the mean score in the cognitive status evaluated with the Neuropsychological study (using the Global Cognitive Impairment Index) in the early period and at one year after treatment between both treatment groups (SVA_Q or TAVI). To compute the Global Cognitive Impairment Index (IDCG), first the direct scores obtained in the different neuropsychological tests will be transformed into z scores according to the scales of the normal population and taking into account age and level of schooling. The different tests will be grouped into cognitive domains that have been identified as relevant to detect the cognitive vascular impairment (CVI) to obtain subscripts of speed, attention, memory, language, visuospatial capacity and executive functions. The IDCG will include an average of the different domains evaluated.
次要结局
- Measure and compare the disability due to new clinical strokes in both groups after procedures and till the end of follow-up.(The ischemic strokes will be evaluated in both groups during all the postoperative follow-up, so one year after treatment.)
- Comparison the number of silent ischemic lesions (MRI) between both groups after procedures in the late respect baseline period.(The ischemic silent lesions will be evaluated in both groups in the early (one month) and late period of follow-up (one year), after the procedures.)
- Rate of patients changing the cognitive status between baseline to end of follow-up in both groups and the relationship between this change with the functional data obtained with MRI(The data obtained with functional MRI will be compared with cognitive status one year after the procedures.)
- Assess changes in functional networks in those patients that developed cognitive impairment during the study (one year)(Evaluation of functional networks at baseline and at an average of one year)
- Comparison the incidence of number of new clinical ischemic strokes between both groups after procedures between baseline and one year after treatment (end of follow-up).(The ischemic strokes will be evaluated in both groups during all the postoperative follow-up, so one year after treatment.)
- Comparison the number of silent ischemic lesions (MRI) between both groups after procedures in the early respect baseline period..(The ischemic silent lesions will be evaluated in both groups in the early (one month) and late period of follow-up (one year), after the procedures.)
- Incidence of patients changing the cognitive status between baseline to end of follow-up in both groups and the correlation between this change and the number of new silent lesions in one year MRI.(Cognitive status (MMSE) and silent lesions will be obtained at baseline, one month and one year.)
- Comparison the size of silent ischemic lesions (MRI) between both groups after procedures(The ischemic silent lesions will be evaluated in both groups in the early (one month) and late period of follow-up (one year), after the procedures)
- Incidence of patients changing the cognitive status between baseline to end of follow-up in both groups and the correlation between this change with the structural data obtained with MRI(The data obtained with structural MRI will be compared with cognitive status one year after the procedures.)