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Frailty and Cognitive Function Assessment of TAVI Patients

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ClinicalTrials.gov Identifier: NCT02650388
Recruitment Status : Unknown
Verified December 2015 by ANDREKA PETER, Hungarian Institute of Cardiology.
Recruitment status was:  Recruiting
First Posted : January 8, 2016
Last Update Posted : January 8, 2016
Sponsor:
Collaborator:
Semmelweis University
Information provided by (Responsible Party):
ANDREKA PETER, Hungarian Institute of Cardiology

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.

Condition or disease Intervention/treatment Phase
Quality of Life Aortic Valve Stenosis Heart Valve Disease Behavioral: Cognitive fuction, quality of life Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Frailty and Cognitive Function Assessment of TAVI Patients (The Hungarian Frailty Score) - Observational, Prospective, Singe Center Study
Study Start Date : November 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Post TAVI neurocognitive outcome
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
To test the above score in patients undergoing TAVI
Other Names:
  • 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




Primary Outcome Measures :
  1. To correlate HFS with mortality at 30 days and 1-year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Find correlation and differences between HFS and QoL [ Time Frame: 1 year ]
  2. Find correlation and differences between HFS and eyeball testing [ Time Frame: 1 year ]
  3. Find correlation and differences between HFS and cognitive outcomes. [ Time Frame: 1 year ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Died before TAVI
  • Not willing to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650388


Contacts
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Contact: Peter Andreka, MD, PhD. 0036703820470 andreka.peter@kardio.hu
Contact: Gabor Dekany, MD 0036703796101 dekany.gabor@kardio.hu

Locations
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Hungary
Hungarian Institute of Cardiology Recruiting
Budapest, Hungary, 1096
Contact: Gabor no Dekany, MD    00367037996101    dekany.gabor@kardio.hu   
Principal Investigator: Gabor Dekany, MD         
Sub-Investigator: Marton Asztalos, MD         
Sub-Investigator: Adrienn Manzak, MD         
Sub-Investigator: Geza Fontos, MD         
Sub-Investigator: NIkolett Hegedus, M.Sc         
Principal Investigator: Peter Andreka, MD, PhD.         
Sponsors and Collaborators
Hungarian Institute of Cardiology
Semmelweis University
Investigators
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Principal Investigator: Peter Andreka, MD, PhD. Hungarían Institute of Cardiology

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Responsible Party: ANDREKA PETER, Professor and Head of the department, Hungarian Institute of Cardiology
ClinicalTrials.gov Identifier: NCT02650388     History of Changes
Other Study ID Numbers: 56174-1/2015/EKU(0470/15)
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Frailty
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction