- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04535076
Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement (COSTA)
September 21, 2023 updated by: Heart and Brain Research Group, Germany
Aortic valve stenosis is one of the most common types of heart disease in the aging Western population.
While surgical cardiac valve replacement (SAVR) is a standard therapy for patients with aortic stenosis, catheter-assisted aortic valve implantation (TAVI) has developed as an alternative to open-heart surgery, especially for high-risk patients.
Recently, increased surgeon experience and improved transcatheter valve systems have led to a global trend to use TAVI in patients with low or intermediate risk.
Although cognitive impairment after cardiac surgery is well known, the effect of TAVI on cognitive function has not yet been adequately investigated.
The aim of this study is to compare the occurrence and progression of delirium, postoperative cognitive decline (POCD), cerebral infarction, and health-related quality of life (QOL) in patients with intermediate risk for catheter-assisted (TAVI) and surgical (SAVR) aortic valve replacement.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The present project is a substudy of the DEDICATE Trial (ID: NCT03112980).
It is a randomized intervention study taking place at the Kerckhoff-Klink Bad Nauheim Germany (Campus Justus Liebig University Giessen) involving 100 patients undergoing aortic valve replacement (TAVI vs. SAVR) with a focus on cognitive outcome.
A detailed assessment of psychological and health-related functions will be performed before intervention, during hospitalization and 3 months after intervention.
During hospitalization, the occurrence and progression of delirium will be assessed with the Intensive Care Delirium Screening Checklist (ICDSC).
Other cognitive data will be collected before and 3 months after surgery with a selected and comprehensive neuropsychological test battery, including the evaluation of attention, word fluency, executive functions and various functional areas of memory.
In addition, parameters of health-related QOL will be collected before and 3 months after the intervention using the SF-36, and information on anxiety and depression will be collected using the Hospital Anxiety and Depression Scale (HADS).
A few days after the intervention, magnetic resonance images of the brain will be acquired to assess cerebral infarction.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marius Butz, Dipl.-Psych.
- Phone Number: +496032 996 5812
- Email: m.butz@kerckhoff-klinik.de
Study Contact Backup
- Name: Martin Jünemann, Dr.med.M.Sc.
- Phone Number: +49641 98545301
- Email: Martin.Juenemann@neuro.med.uni-giessen.de
Study Locations
-
-
-
Bad Nauheim, Germany, 61231
- Department of Cardiac Surgery, Kerckhoff-Klinik GmbH
-
-
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
63 years to 83 years (Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Heart team decision that both TAVI and SAVR are medically justified based on
Degenerative aortic valve stenosis:
- Mean gradient > 40 mmHg or
- Jet velocity > 40 m/s or
- Surface of aortic valve < 1.0 cm²
Patient shows symptoms of aortic stenosis
- NYHA functional class ≥ II or
- Angina pectoris or
- Syncope
- Low to intermediate surgical risk (STS: 2-6%)
- A transfemoral or alternative access for TAVI can be implemented
- Patient has agreed in writing to participate in the study
- Patient is able to understand the patient information and sign it personally
- Patient agrees to undergo SAVR if randomization into the control group occurs
- Readiness for MRT examination and neuropsychological testing after 3 months
- Patients aged 65 to 85 years.
- Native German speaker (since a neuropsychological test is language dependent)
Exclusion Criteria:
- Congenital aortic valve defects
- Untreated clinically significant coronary artery disease or severe mitral or tricuspid insufficiency or mitral stenosis
- Previous heart surgery
- Percutaneous coronary intervention performed within one month prior to the study
- Hemodynamic instability requiring inotropic support or mechanical circulatory support
- Ischemic stroke or intracranial bleeding within the month before the start of the study
- Severe ventricular dysfunction with left ventricular ejection fraction < 20% as measured by echocardiogram
- Hypertrophic obstructive cardiomyopathy or severe basal septum hypertrophy
- Echocardiographic detection of intracardiac mass, thrombus, vegetation, or endocarditis
- Any other atherosclerotic disease that is considered as a contraindication for isolated aortic valve surgery
- Symptomatic carotid or vertebral artery disease
- Existing neurological or psychiatric disease (particularly cerebral infarction, cranio- cerebral trauma, manifest depression or dementia) that may interfere with neuropsychological testing.
- Contraindications for MRI examination (e.g. cardiac pacemaker, vena cava filter, claustrophobia)
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transcatheter Aortic Valve Implantation
|
Transcatheter Aortic Valve Implantation
|
Active Comparator: Surgical Aortic Valve Replacement
|
Surgical Aortic Valve Replacement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with postoperative cognitive decline at 3 months after surgery, defined as a decrease between pre- and postoperative examinations of one standard deviation in at least 20% of all objective neuropsychological parameters
Time Frame: Immediately pre-surgery to 3 months post-surgery
|
The objective neuropsychological parameters measure cognitive domains like immediate memory span, free recall, recognition memory, selective attention, working memory, inhibition and word fluency.
These cognitive domains will be measured with the following instruments: "Verbaler Lern- und Merkfähigkeitstest" (VLMT), "Trail Making Test A/B" (TMT), "Letter Number Span Test" (LNS), Block Tapping Test (BTT), "Regensburger Wortflüssigkeits-Test" (RWT), and "Syndrom-Kurz Test" (SKT).
|
Immediately pre-surgery to 3 months post-surgery
|
Number of participants with postoperative cognitive decline at the time of discharge from the acute clinic, defined as a decrease between the pre- and postoperative examinations of one standard deviation measured with the "Montreal Cognitive Assessment"
Time Frame: Immediately pre-surgery to approximately 1 week post-surgery
|
The "Montreal Cognitive Assessment" (MOCA) is a screening procedure for general cognitive function.
|
Immediately pre-surgery to approximately 1 week post-surgery
|
Number of participants with postoperative delirium during the stay in the intensive care unit as assessed by the "Intensive Care Delirium Screening Checklist" (ICDSC)
Time Frame: Immediately post-surgery to approximately 7 days post-surgery
|
Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in the intensive care unit.
The "Intensive Care Delirium Screening Checklist" (ICDSC) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.
|
Immediately post-surgery to approximately 7 days post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed by the "Cognitive Failures Questionnaire" (CFQ)
Time Frame: Immediately pre-surgery to 3 months post-surgery
|
The "Cognitive Failures Questionnaire" (CFQ) measure the frequency of failures in daily living in terms of memory, attention, action, and perception.
It comprises 29 questions, which are answered on a 5-step Likert scale.
Higher scores mean a worse outcome.
|
Immediately pre-surgery to 3 months post-surgery
|
Change from baseline health-related quality of life at 3 months after surgery as assessed by the "36-Item Short Form Health Survey" (SF36)
Time Frame: Immediately pre-surgery to 3 months post-surgery
|
The "36-Item Short Form Health Survey" (SF36) includes 36 questions covering 8 health-related factors: vitality, physical functioning, bodily pain, general health perception, physical role function, emotional role function, social role functioning, and mental health.
An aggregated percentage score is calculated for each of the eight factors.
The percentage scores range from 0% to 100%.
Higher scores mean a better outcome.
|
Immediately pre-surgery to 3 months post-surgery
|
Change from baseline anxiety at 3 months after surgery as assessed by the "Hospital Anxiety and Depression Scale" (HADS).
Time Frame: Immediately pre-surgery to 3 months post-surgery
|
With the "Hospital Anxiety and Depression Scale" (HADS), an instrument will be used that refers to the psychological core aspects of depression and anxiety.
Each scale contains 7 questions to be answered on a 4-step Likert scale by the patients themselves.
After inverting negative questions, higher scores mean a worse outcome.
|
Immediately pre-surgery to 3 months post-surgery
|
Change from baseline depression at 3 months after surgery as assessed by the "Hospital Anxiety and Depression Scale" (HADS).
Time Frame: Immediately pre-surgery to 3 months post-surgery
|
With the "Hospital Anxiety and Depression Scale" (HADS), an instrument will be used that refers to the psychological core aspects of depression and anxiety.
Each scale contains 7 questions to be answered on a 4-step Likert scale by the patients themselves.
After inverting negative questions, higher scores mean a worse outcome.
|
Immediately pre-surgery to 3 months post-surgery
|
Number of participants with postoperative acute ischemic lesions at the time of discharge from the acute clinic as assessed by magnetic resonance images (MRI).
Time Frame: Once within the 6th-10th day immediately post-surgery
|
Cranial MRI will be performed using a 3-T scanner (Skyra; Siemens, Erlangen, Germany).
The protocol of imaging will include a T2-weighted turbo spin-echo sequence, a T2-weighted turbo spin-echo sequence for dark fluid, a T1-weighted FLASH sequence and a diffusion-weighted echo-planar imaging sequence.
|
Once within the 6th-10th day immediately post-surgery
|
Number of participants with postoperative microemboli at the time of discharge from the acute clinic as assessed by magnetic resonance images (MRI).
Time Frame: Once within the 6th-10th day immediately post-surgery
|
Cranial MRI will be performed using a 3-T scanner (Skyra; Siemens, Erlangen, Germany).
The protocol of imaging will include a T2-weighted turbo spin-echo sequence, a T2-weighted turbo spin-echo sequence for dark fluid, a T1-weighted FLASH sequence and a diffusion-weighted echo-planar imaging sequence.
|
Once within the 6th-10th day immediately post-surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marius Butz, Dipl.-Psych., Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim
- Principal Investigator: Tibo Gerriets, Prof.Dr.med., Department of Neurology, Gesundheitszentrum Wetterau
- Principal Investigator: Markus Schönburg, Prof.Dr.med., Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim
- Principal Investigator: Martin Jünemann, Dr.med.M.Sc., Clinic for Neurology, University Hospital Gießen
- Principal Investigator: Won-Keun Kim, Dr.med., Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim
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)
February 28, 2019
Primary Completion (Actual)
December 19, 2022
Study Completion (Actual)
December 19, 2022
Study Registration Dates
First Submitted
August 27, 2020
First Submitted That Met QC Criteria
August 27, 2020
First Posted (Actual)
September 1, 2020
Study Record Updates
Last Update Posted (Actual)
September 22, 2023
Last Update Submitted That Met QC Criteria
September 21, 2023
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MC 68/2017
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 Postoperative Delirium
-
Qin ZhangNational Natural Science Foundation of ChinaRecruiting
-
Qin ZhangNational Natural Science Foundation of ChinaRecruitingDelirium, PostoperativeChina
-
University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyRecruitingPostoperative Delirium (POD)Switzerland
-
Konya City HospitalCompletedPREOPERATIVE SLEEP QUALITY ON POSTOPERATIVE DELIRIUMTurkey
-
University of VirginiaNational Institutes of Health (NIH); National Institute on Aging (NIA)RecruitingIdentify Postoperative Delirium Using Exhaled Gas PatternsUnited States
-
University Hospital, GhentCompletedPostoperative Pain | Postoperative DeliriumBelgium
-
Menoufia UniversityCompleted
-
Heart and Brain Research Group, GermanyRecruitingPostoperative Delirium | Postoperative Cognitive Dysfunction | Postoperative Cognitive DeclineGermany
-
Marmara UniversityActive, not recruitingPostoperative Delirium | Postoperative Nausea | Postoperative VomitingTurkey
-
West China HospitalRecruitingDelirium | Postoperative Cognitive DysfunctionChina
Clinical Trials on Transcatheter Aortic Valve Implantation
-
Clinique PasteurUnknownBicuspid Aortic ValveFrance
-
University of PadovaFondazione GISE OnlusRecruiting
-
Xijing HospitalRecruitingAortic Valve Disease MixedChina
-
Edwards LifesciencesCompletedSevere Aortic StenosisSpain, Italy, Canada, Belgium, Greece, Germany, Austria, United Kingdom, Finland, Denmark, France, Switzerland, Israel, Poland, South Africa, Czechia, Netherlands, Norway
-
Medical University of WarsawRecruitingAortic Valve Stenosis | Ventricular Outflow Obstruction, LeftPoland
-
Segeberger Kliniken GmbHCompleted
-
IRCCS Policlinico S. DonatoRecruiting
-
University of AthensRecruitingTranscatheter Aortic Valve ReplacementGreece
-
Centre Cardiologique du NordUniversita degli Studi di Genova; Campus Bio-Medico University; Henri Mondor... and other collaboratorsActive, not recruitingProsthesis Survival | Prosthesis; Cardiac, Heart, Functional Disturbance as ResultFrance
-
Central Hospital, Nancy, FranceNot yet recruitingTranscatheter Aortic Valve Replacement