Neuropsychological and Neuroimaging Evaluation of the Cognitive Impairment in Aortic Valve Replacement (ARTiCO)

NCT05235529 | Unknown

• 1 other identifier: HUGTiP_ISC III_ PI19/01397
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement; Surgical Treatment; Cognitive Impairment; Stroke

Keywords

Silent stroke

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (9)

• 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.

• 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 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.

• 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.

• 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

Study Arms (2)

Aortic valve replacement with surgery (SVAo)

This group of patients with severe aortic stenosis will be treated with aortic valve replacement with surgery.

Procedure: Aortic valve replacement

Transcatheter aortic valve implant (TAVI)

This group of patients with severe aortic stenosis will be treated with transcatheter aortic valve implant (TAVI).

Device: TAVI

Interventions

Aortic valve replacement PROCEDURE

Surgery replacement od the aortic valve

Aortic valve replacement with surgery (SVAo)

TAVI DEVICE

Transcatheter aortic valve implantation

Transcatheter aortic valve implant (TAVI)

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population that will be analyzed in this study are those patients with severe aortic stenosis that are candidates on valve replacement treatment. Those who present an intermediate or high surgical risk, over 70 years and who are candidates for both a surgical replacement and a TAVI and who present a normal cognitive state evaluated by a neurologist will be included.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Meritxell Gomis Cortina

Badalona, Barcelona, 08917, Spain

RECRUITING

Related Publications (1)

• Gomis M, Fernandez C, Dacosta-Aguayo R, Carrillo X, Martinez S, Guijosa CM, Berastegui E, Valentin AG, Puig J, Bernal E, Ramos A, Caceres C. Aortic valve Replacement compared to Transcatheter Implant and its relationship with COgnitive Impairment (ARTICO) evaluated with neuropsychological and advanced neuroimaging: a longitudinal cohort study. BMC Neurol. 2023 Aug 23;23(1):310. doi: 10.1186/s12883-023-03362-9.

  PMID: 37612651 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Cognitive Dysfunction; Stroke

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Meritxell Gomis, MD, PhD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meritxell Gomis, MD, PhD

CONTACT

606 22 99 97; meritxellgomis@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: February 11, 2022
• Study Start: January 4, 2021
• Primary Completion: March 1, 2022
• Study Completion: December 1, 2023
• Last Updated: February 11, 2022

Record last verified: 2021-11

Locations

ES (1)