Stroke Clinical Trial
— ARTiCOOfficial title:
Neuropsychological and Advanced Neuroimaging Evaluation of the Impact of Cognitive Impairment in Conventional Aortic Valve Replacement Compared to the Transcatheter Implant
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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | December 2023 |
Est. primary completion date | March 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. presence of severe / symptomatic aortic stenosis with indication for elective Aortic Valve Replacement 2. patients with intermediate or high surgical risk evaluated by EuroScore II 3-10%, susceptible to be treated with both techniques 3. age> 70 years Exclusion Criteria: 1. contraindication to perform an MRI 2. severe renal failure 3. severe psychiatric illnesses 4. Diagnosed dementia or Mini Mental State Examination (MMSE) <19/35 corrected for age and education 5. surgical reintervention 6. patients with preoperative comorbidities that condition difficulties for a one-year clinical follow-up 7. aortic surgery concomitant to AVS or other than coronary revascularization |
Country | Name | City | State |
---|---|---|---|
Spain | Meritxell Gomis Cortina | Badalona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Germans Trias i Pujol Hospital | Instituto de Salud Carlos III |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline neuropsychological study at early period (one month) after treatment in both groups | 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. | The cognition will be evaluated in two different time frames; at baseline and early period (one month) after the procedures. | |
Primary | Change from baseline neuropsychological study at late period (one year) after treatment in both groups | 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. | The cognition will be evaluated in two different time frames; at baseline and late period (one year) after the procedures. | |
Primary | Change from early period (one month) neuropsychological study at late period (one year) after treatment in both groups | 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. | The cognition will be evaluated in two different time frames; early period (one month) and late period (one year) after the procedures. | |
Secondary | 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). | Compare the number of new symptomatic ischemic strokes observed in MRI that occur in the postoperative period of aortic valve replacement, between both groups at one year after treatment respect baseline. | The ischemic strokes will be evaluated in both groups during all the postoperative follow-up, so one year after treatment. | |
Secondary | Measure and compare the disability due to new clinical strokes in both groups after procedures and till the end of follow-up. | Describe the clinical strokes that occur in the postoperative period of aortic valve replacement, between both groups till the end of follow-up. To measure the disability due to new clinical strokes the investigators will use mRS. The modified Rankin score (mRS) ranged from 0 to 6. 0 is normal and 6 is dead. | The ischemic strokes will be evaluated in both groups during all the postoperative follow-up, so one year after treatment. | |
Secondary | Comparison the number of silent ischemic lesions (MRI) between both groups after procedures in the early respect baseline period.. | Compare the number of silent ischemic lesions that occur in the postoperative period of aortic valve replacement, between both groups in the early respect the 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. | |
Secondary | Comparison the number of silent ischemic lesions (MRI) between both groups after procedures in the late respect baseline period. | Compare the number of silent ischemic lesions that occur in the postoperative period of aortic valve replacement, between both groups in the late respect the 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. | |
Secondary | Comparison the size of silent ischemic lesions (MRI) between both groups after procedures | Compare the total size of all new silent lesions that are observed in the last MRI performed compared to baseline MRI after the aortic valve replacement, between both groups. The size of lesions will be obtained from MRI and calculated in milliliters. | 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 | |
Secondary | 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. | Rate of patients that change the cognitive status (normal; mild cognitive impairment; moderate cognitive impairment) measured with the MMSE between baseline and the end of follow-up in both groups and related with the number of new silent lesions observed in MRI between baseline to one year MRI. The cognitive status is evaluated with MMSE. Normal >25; mild cognitive impairment 20-24 and moderate cognitive impairment <15. The new silent lesions will be a number and a correlation will be done. | Cognitive status (MMSE) and silent lesions will be obtained at baseline, one month and one year. | |
Secondary | 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 | Rate of patients that change the cognitive status (normal; mild cognitive impairment; moderate cognitive impairment) measured with the MMSE between baseline and the end of follow-up in both groups and related with the neuroanatomical data of the MRI (DTI, T1-weighted image, as well as T2-weighted images and fluid attenuated inversion recovery image (FLAIR) with the objective of assessing the presence of lesions of the white matter and lacunar infarcts as well as the appearance of silent lesions) between baseline to one year MRI. The cognitive status is evaluated with MMSE. Normal >25; mild cognitive impairment 20-24 and moderate cognitive impairment <15. The presence in number of lacunar infarcts and the volume in cc of lesions of the white matter will be calculated and a correlation will be done. | The data obtained with structural MRI will be compared with cognitive status one year after the procedures. | |
Secondary | 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 | Rate of patients that change the cognitive status (normal; mild cognitive impairment; moderate cognitive impairment) measured with the MMSE between baseline and the end of follow-up in both groups and related with the functional data of the MRI (resting state) between baseline to one year MRI. The cognitive status is evaluated with MMSE. Normal >25; mild cognitive impairment 20-24 and moderate cognitive impairment <15. | The data obtained with functional MRI will be compared with cognitive status one year after the procedures. | |
Secondary | Assess changes in functional networks in those patients that developed cognitive impairment during the study (one year) | Assess whether there are or not changes in the following functional networks; Default Mode Network (DMN), Salience Network (SN), Central Executive Network (CEN) in subjects who develop cognitive impairment in both groups. Cognitive impairment will be measured with MMSE. It will be considered cognitive impairment if MMSE<25. | Evaluation of functional networks at baseline and at an average of one year |
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