Frailty and Cognitive Function Assessment of TAVI Patients

NCT02650388 | Unknown Phase 4

• 1 other identifier: 56174-1/2015/EKU(0470/15)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Aortic stenosis (AS) is the most common valve disease among the adult population, in the majority of the cases it only requires treatment in advanced age. Transcatheter aortic valve implantation (TAVI) has become available as an alternative treatment for very high risk or even inoperative patients who are suffering from symptomatic aortic stenosis. Until now it has been learnt that there are group of patients who are in a very bad condition and who are so frail that they do not benefit from TAVI. These patients have worse survival rate and more importantly poor quality of life in spite of a successful procedure. Cardiac surgery risk scores like Society of Thoracic surgery score (STS) and EUROSCORE are less accurate in aging high risk people. In elderly it is principal to make differentiation between utility and futility. On the other hand, beside frailty status the main barrier to TAVI is the risk of neurological impairment. Neurological injury and impairment in TAVI can occur as cerebrovascular event (CVE) and/or neurocognitive dysfunction. The two neurocognitive dysfunctions - post-operative delirium (POD) and post-operative cognitive dysfunction (POCD). Most cases remain undetected although clinically could be apparent or silent. The neurological injury can be observed and/or detected by neuroimaging techniques and cognitive trajectories. A well established and validated frailty score based on relatively simple and feasible tests could help in our everyday practice to evaluate the prognosis of elderly people undergoing TAVI and to determine those patients who really benefit from the procedure.

Conditions

Quality of Life; Aortic Valve Stenosis; Heart Valve Disease

Outcome Measures

Primary Outcomes (1)

• To correlate HFS with mortality at 30 days and 1-year

  1 year

Secondary Outcomes (3)

• Find correlation and differences between HFS and QoL

  1 year

• Find correlation and differences between HFS and eyeball testing

  1 year

• Find correlation and differences between HFS and cognitive outcomes.

  1 year

Study Arms (1)

Post TAVI neurocognitive outcome

OTHER

TAVI with CoreValve will be done for all the patients and outcome will be assessed as Cognitive fuction, quality of life, Gait speed, Hand grip strength, Activities of daily living (ADL), Instrumental activities of daily living (IADL), Short- Form Mini Nutritional assessment (SF-MNA), Serum albumin level, Hemoglobin level, BMI, Montreal cognitive Assessment (MOCA), EQ-5D-3L-questionnaire, Ferreans and Powers Quality of life Index (QLI), MOCA, RBANS, Wisconsin test, Stroop test, Fluency test, Subjective "Eyeball test", Serial Transcranial Doppler (TCD) during TAVI. Finally, Hungarian frailty score will be deduced.

Behavioral: Cognitive fuction, quality of life

Interventions

Cognitive fuction, quality of life BEHAVIORAL

To test the above score in patients undergoing TAVI

Also known as: Gait speed, Hand grip strength, Activities of daily living (ADL), Instrumental activities of daily living (IADL), Short- Form Mini Nutritional Assessment (SF-MNA), Serum albumin level, Hemoglobin level, BMI, Montreal Cognitive Assessment (MOCA), EQ-5D-3L-questionnaire, Ferreans and Powers Quality of life Index (QLI), MOCA, RBANS, Wisconsin test, Stroop test, Fluency test, Subjective "Eyeball test", Serial Transcranial Doppler (TCD) during TAVI

Post TAVI neurocognitive outcome

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 75 years,
• Severe, symptomatic aortic stenosis,
• High risk for cardiac surgery (STS and logistic Euroscore ),
• According multidisciplinary (heart) team decision TAVI is preferable,
• Willing to participate

You may not qualify if:

• Died before TAVI
• Not willing to participate

Sponsors & Collaborators

• Hungarian Institute of Cardiology: lead
• Semmelweis University: collaborator

Study Sites (1)

Hungarian Institute of Cardiology

Budapest, Budapest, 1096, Hungary

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases

Interventions

Quality of Life; Walking Speed; Hand Strength; Activities of Daily Living; Serum Albumin; Mental Status and Dementia Tests; Wisconsin Card Sorting Test; Stroop Test

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Muscle Strength; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Peter Andreka, MD, PhD.

  Hungarían Institute of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Andreka, MD, PhD.

CONTACT

0036703820470; andreka.peter@kardio.hu

Gabor Dekany, MD

CONTACT

0036703796101; dekany.gabor@kardio.hu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of the department

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: January 8, 2016
• Study Start: November 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: January 8, 2016

Record last verified: 2015-12

Locations

HU (1)