Impact of TAVI on Cognition, Mood and Health-related Qual... | NCT04371172

Studies
Impact of TAVI on Cognition, Mood and Health-related Quality of Life

NCT04371172

Sponsor

Medical University of Graz

Status

Unknown status

Last Update Posted

Jan 11, 2023Actual

Enrollment

128Estimated

Phase

Not provided

Conditions

Cognitive Impairment

Interventions

cognitive research battery, MRI, laboratory values

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
32-249 ex19/20	Other Identifier	Ethikkommission, Medical university of Graz

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2023Estimated

Primary Completion Date

May 29, 2025Estimated

Completion Date

May 29, 2025Estimated

First Submitted Date

Apr 29, 2020

First Submission Date that Met QC Criteria

Apr 29, 2020

First Posted Date

May 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2023

Last Update Posted Date

Jan 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In the proposed study, patients with and without embolic protection devices during Transcatheter Aortic Valve Implantation will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a post-interventional period of 6 months after TAVI, with regard to the effects on mood, cognitive Performance and health-related Quality of life.

Detailed Description

The percutaneous aortic valve replacement (TAVI, Transcatheter Aortic Valve Implantation) enables the implantation of a new biological aortic valve at the beating heart. The procedure is performed under local anaesthesia and is a gold standard in the therapy of aortic stenosis, especially in patients with a too high health risk for cardiovascular surgery.

In the proposed study, patients with and without embolic protection devices during TAVI will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a post-interventional period of 6 months after TAVI, with regard to the effects on mood, cognitive Performance and health-related quality of life.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

128Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with TAVI		cognitive research battery, MRI, laboratory values	Other: cognitive research battery, MRI, laboratory values

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cognitive research battery, MRI, laboratory values	Other	cognitive research battery, MRI, laboratory values	Patients with TAVI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cognition	Montreal-Cognitive-Assessment, cognitive test battery	12 months

Secondary Outcomes

Measure	Description	Time Frame
health-related quality of life	Short Form (36) Health Survey (SF-36): The SF-36 consists of 8 scales. scores. Each scale is directly transformed into a 0-100 scale. A score of 100 is equivalent to no disability.	12 months

Other Outcomes

Measure	Description	Time Frame
mood	Hospital Anxiety and Depression Scale (HADS): A person can score between 0 and 21 for either anxiety or depression); Montgomery-Åsberg Depression Rating Scale: usual cutoff points are: 0 to 6 - normal, 7 to 19 - mild depression, 20 to 34 - moderate depression, >34 - severe Depression	12 months
MRI

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written declaration of consent of the study participants to participate in the study after detailed information on the nature, significance, risks and scope of the study.
Women and men between the ages of 19 and 90
Clinical indication for TAVI intervention
No previous psychiatric illness before TAVI
No other serious disease affecting the immune system

Exclusion Criteria:

Non-compliance with the inclusion criteria
Persons unable to give consent (e.g. dementia, delirium etc.)
Magnetic resonance imaging (MR) contraindications
ophthalmological inability to read

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with percutaneous aortic valve replacement

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andreas Baranyi, Prof.	Contact	0043-316-385-86241		an.baranyi@medunigraz.at
Albrecht Schmidt, PD.	Contact	0043-316-385		albrecht.schmidt@klinikum-graz.at

Overall Officials

Name	Affiliation	Role
Andreas Baranyi, Prof.	Medical University Graz, Austria	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz		Graz	Styria	8036	Austria

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided