Pre- and Post TAVI Cognitive Functioning and Intraoperative Carotid Flow Measurements

April 3, 2023 updated by: Mariska te Pas, Catharina Ziekenhuis Eindhoven

Usability Study of the BAMCOG Followed by Concurrent Validation of the BAMCOG With the MoCA as a Monitoring Instrument for Perioperative Cognitive Function

Purpose:

  1. Measuring and optimize the usability of the BAMCOG (games to measure cognitive functioning)
  2. Concurrent validation of BAMCOG with MoCA to see if BAMCOG can serve as a monitoring instrument/screener
  3. Determination of carotid flow/cerebral blood flow pre- and post implant of prosthesis of aortic valve by ultrasound doppler measurements

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Eindhoven, Netherlands
        • Catharina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Elderly patients undergoing TAVI surgery

Description

Inclusion Criteria:

  • > 65 years old
  • Scheduled for TAVI surgery
  • Able to play games on a tablet
  • For usability part > MoCA score of 26 or higher
  • Near native dutch speaker

Exclusion Criteria:

  • Mental disorder (unable to play games)
  • Alcohol abuse (women <15 and men >22 alcoholic drinks/week)
  • No informed consent
  • Atrial fibrillitation (for ultrasound doppler)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Usability of BAMCOG
Time Frame: 3 months preoperative
3 months preoperative
Concurrent validation of BAMCOG with MoCA
Time Frame: 3 months preoperative - 3 months postoperative
3 months preoperative - 3 months postoperative
Cerebral perfusion/carotid flow measurements
Time Frame: Peroperative
Peroperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catharina Ziekenhuis Eindhoven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nWMO-2020.106

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Impairment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe