Brain Lesions After Transcatheter Aortic Valve Replacement
27 december 2021 uppdaterad av: Mao Chen, West China Hospital
The Brain lEsions after TrAnscatheter aorTic ValvE Replacement (BETTER) registry is a prospective, observational, multi-center registry aiming to assess the presence of new brain microbleeds assessed on susceptibility-weighted imaging at 3 enrolling sites, in China (West China Hospital, Sichuan University), UK (St Thomas' Hospital) and Denmark (Rigshospitalet, University of Copenhagen).
The main study arm is planned to include 100 patients with symptomatic severe aortic stenosis undergoing transfemoral TAVR of any devices and 50 isolated bioprosthetic SAVR patients treated during the enrollment period as a control arm.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
"Silent" stroke post-TAVR presents as asymptomatic brain ischemic lesions detected on diffusion-weighted magnetic resonance imaging (DW-MRI), with an incidence ranging from 60% to 100% in different studies.
On the contrary, hemorrhagic lesions are not systematically studied given the poor visualization of small hemorrhage (i.e.
microbleeds) on traditional T1, T2 or DW-MRI sequences.
We have previously identified an incidence of new brain microbleeds early after TAVR of 100% with the routine use of susceptibility-weighted imaging (SWI).
We hypothesize that new brain microbleeds are prevalent in patients with aortic stenosis after either TAVR or SAVR.
The key objective of this registry is to evaluate the incidence, distribution and clinical impact of new brain microbleeds after transfemoral TAVR in patients with symptomatic severe aortic stenosis, in comparison with SAVR.
Studietyp
Observationell
Inskrivning (Förväntat)
150
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Tian-Yuan Xiong, MBBS, PhD
- Telefonnummer: +86-028-85423582
- E-post: xiongtianyuan@wchscu.cn
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
60 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients with symptomatic severe aortic stenosis (>60 years old) being scheduled for either transfemoral TAVR or isolated SAVR at enrolling sites will be invited to participate in the study
Beskrivning
Inclusion Criteria:
- Symptomatic severe aortic stenosis (>60 years old) being scheduled for either transfemoral TAVR or isolated SAVR
Exclusion Criteria:
- Patients who have been diagnosed with brain cancer, brain haemorrhage, brain abscess, aneurysm, cerebral palsy, encephalitis, nervous system infection, head or neurological injury, or trauma, stroke
- Contraindications for a magnetic resonance imaging (MRI) scan (i.e. metallic implants, claustrophobia, MR-incompatible pacemakers or prosthetic heart valves)
- Unremovable dental prostheses that are deemed to affect MRI quality
- Severe coronary artery disease that is unrevascularized
- Prior stroke within the last 12 months
- Expected non-compliance concerning follow-up examinations
- Have participated in other clinical trials
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
TAVR arm
Symptomatic severe aortic stenosis undergoing transfemoral TAVR of any devices
|
Brain MRI will be scheduled within three days before the procedure and within seven days after the procedure, as well as at 1-year follow-up.
MRI will be preferably performed using a 3.0-Tesla system unless patients are pacemaker-dependent after the procedure.
In such case, a 1.5-Tesla system will be used.
The MRI protocol consists of standardized conventional diffusion-weighted MRI (DW-MRI), T2-FLAIR (fluid-attenuated recovery inversion) and SWI (susceptibility-weighted imaging) parameters.
Andra namn:
|
|
SAVR arm
Symptomatic severe aortic stenosis undergoing isolated bioprosthetic surgical aortic valve replacement
|
Brain MRI will be scheduled within three days before the procedure and within seven days after the procedure, as well as at 1-year follow-up.
MRI will be preferably performed using a 3.0-Tesla system unless patients are pacemaker-dependent after the procedure.
In such case, a 1.5-Tesla system will be used.
The MRI protocol consists of standardized conventional diffusion-weighted MRI (DW-MRI), T2-FLAIR (fluid-attenuated recovery inversion) and SWI (susceptibility-weighted imaging) parameters.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The incidence of new brain microbleeds detected on MRI
Tidsram: Post-procedurally (up to 7 days) and 6 months
|
Microbleeds (including the number and size) on SWI after TAVR or SAVR during the index hospitalization and their evolution at the follow-up
|
Post-procedurally (up to 7 days) and 6 months
|
|
The incidence of new brain embolisms detected on MRI
Tidsram: Post-procedurally (up to 7 days) and 6 months
|
Ischemic infarcts (including the number and size) on DW-MRI after TAVR or SAVR during the index hospitalization and their evolution at the follow-up
|
Post-procedurally (up to 7 days) and 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in the neurological and cognitive status of the patients (see description for specific assessments)
Tidsram: Post-procedurally (up to 7 days), 6 months and 1 year
|
NIH Stroke Scale (NIHSS) and Montreal Cognitive Assessment (MoCA, cognitive impairment = score <23/30) for overall cognitive status, and tests for five individual cognitive domains (Attention: Digit Symbol-Coding test [DSST]; Memory: Hopkins Verbal Learning Test-Revised [HVLT-R], Brief Visual Memory Test-Revised [BVMT-R]; Executive Function: Stroop Color-Word Association Test [SCWT], Category and Verbal Fluency [both semantic and phonemic]; Visuospatial Function: BVMT-R).
The change of score in each assessment will be calculated.
|
Post-procedurally (up to 7 days), 6 months and 1 year
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Perfusion changes on transcranial doppler during TAVR or SAVR (if obtained)
Tidsram: Intra-procedurally
|
Baseline perfusion will be obtained before femoral puncture in TAVR and the start of cardiopulmonary bypass in SAVR, until completion of eventual postimplantation maneuvers in TAVR and the stop of cardiopulmonary bypass in SAVR
|
Intra-procedurally
|
Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 januari 2022
Primärt slutförande (Förväntat)
1 januari 2023
Avslutad studie (Förväntat)
1 januari 2024
Studieregistreringsdatum
Först inskickad
8 september 2021
Först inskickad som uppfyllde QC-kriterierna
22 september 2021
Första postat (Faktisk)
4 oktober 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 januari 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 december 2021
Senast verifierad
1 december 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2021V1
Läkemedels- och apparatinformation, studiedokument
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