Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603454
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-27
Brief Title:
Preoperative Chest CT-imaging in Surgical Aortic Valve Replacement with or Without CABG
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Preoperative Chest CT-imaging in Surgical Aortic Valve Replacement with or Without CABG a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GUIDE-SAVR
Brief Summary:
Rationale When determining the strategy for aortic valve replacement echocardiography is still considered the golden standard 1 While pre-procedural MSCT is standard of care in TAVR patients this is not yet part of routine clinical practice in SAVR patients The researchers hypothesise that when atherosclerosis of the ascending aorta is identified preoperatively on contrast-enhanced multi-slice computed tomography MSCT the subclinical perioperative stroke rate as detected on diffusion-weighted magnetic resonance imaging DW-MRI can be reduced by modification of the operative strategy if necessary
Detailed Description:
When determining the strategy for aortic valve replacement echocardiography is still considered the golden standard 1 While pre-procedural MSCT is standard of care in TAVR patients this is not yet part of routine clinical practice in SAVR patients The investigators hypothesise that when atherosclerosis of the ascending aorta is identified preoperatively on contrast-enhanced multi-slice computed tomography MSCT the subclinical perioperative stroke rate as detected on diffusion-weighted magnetic resonance imaging DW-MRI can be reduced by modification of the operative strategy if necessary
The primary objective is to assess whether the use of pre-operative MSCT will reduce subclinical stroke rates ie ischemic brain lesions as identified with the use of DW-MRI after SAVR with or without concomitant CABG surgery
The secondary objective is to assess whether the use of pre-operative MSCT will improve neurological assessment score reduce clinical stroke mortality change in intervention strategy pre- or intra-operatively cannulation strategy and clamping strategy as well as reduce procedural times and improve quality of life with the application of EQ-5D and KCCQ questionnaires
This is a prospective multicenter parallel open-label randomized controlled trial RCT with a 11 randomization including patients aged 18 years and older accepted for SAVR with or without concomitant CABG by the Heart Team at the St Antonius Hospital Nieuwegein All patients enrolled in the study will be randomized to additional pre-operative MSCT or no additional pre-operative MSCT Postoperatively a DW-MRI will be made in all patients The trial will end after 30-day follow-up of all enrolled patients
The main primary endpoint is the incidence of subclinical stroke rate ie presence of new ischemic brain lesions as identified with the use of DW-MRI made within one week postoperatively or before discharge Secondary endpoints include the National Institutes of Health Stroke Scale NIHSS score within one week postoperatively targeted at day two postoperatively clinical ischemic stroke conform VARC-3transient ischemic attack diagnosed by a neurologist within one week postoperatively defined by transient focal neurological signs or symptoms lasting 24 h presumed to be due to focal brain spinal cord or retinal ischemia but without evidence of acute infarction by neuroimaging or pathology or with no imaging performed conform VARC-3 mortality at discharge normally at three to five days postoperatively or within one week postoperatively if discharge is 1 week postoperatively and at three months postoperatively the change in intervention strategy the change in cannulation strategy the change in clamping strategy procedural times and the quality of life at three months postoperatively assessed by EQ-5D and KCCQ
When severe calcification of the ascending aorta is identified preoperatively on multi-slice computed tomography MSCT the operative strategy can be modified if necessary This could possibly prevent stroke or even mortality in the study patients randomized to additional pre-operative MSCT The MSCT will take 5-10 minutes Only low-dose contrast-enhanced CT will be used which results in a very low radiation risk With application of too high dosages of contrast there is a slight chance of kidney insufficiency Furthermore an allergic reaction to contrast could occur However patients with known allergies to contrast and patients with low renal function will be excluded from participation in this trial
The patients receiving a preoperative CT-scan will have to be informed about all incidental findings found on the CT-scan A possible disadvantage is found in the additional costs of a CT-scan but the costs associated with stroke would outweigh the costs of a preoperative CT-scan All patients will receive a DW-MRI before discharge Contra-indications for MRI include pacemaker wires or implantable cardioverter defibrillators ICDs metallic implants cochlearear implants Swan-Ganz catheter claustrophobia and contrast allergy The presence of an aortic valve prosthesis is not a contra-indication for DW-MRI scanning
All patients will be asked to fill out a questionnaire at baseline and within 90 days postoperatively Since this will soon be implemented as part of standard care the latter is not seen as extra burden for the patients
The primary objective is to assess whether the use of pre-operative MSCT will reduce subclinical stroke rates ie ischemic brain lesions as identified with the use of DW-MRI after SAVR with or without concomitant CABG surgery
The secondary objective is to assess whether the use of pre-operative MSCT will improve neurological assessment score reduce clinical stroke mortality change in intervention strategy pre- or intra-operatively cannulation strategy and clamping strategy as well as reduce procedural times and improve quality of life with the application of EQ-5D and KCCQ questionnaires
This is a prospective multicenter parallel open-label randomized controlled trial RCT with a 11 randomization including patients aged 18 years and older accepted for SAVR with or without concomitant CABG by the Heart Team at the St Antonius Hospital Nieuwegein All patients enrolled in the study will be randomized to additional pre-operative MSCT or no additional pre-operative MSCT Postoperatively a DW-MRI will be made in all patients The trial will end after 30-day follow-up of all enrolled patients
The main primary endpoint is the incidence of subclinical stroke rate ie presence of new ischemic brain lesions as identified with the use of DW-MRI made within one week postoperatively or before discharge Secondary endpoints include the National Institutes of Health Stroke Scale NIHSS score within one week postoperatively targeted at day two postoperatively clinical ischemic stroke conform VARC-3transient ischemic attack diagnosed by a neurologist within one week postoperatively defined by transient focal neurological signs or symptoms lasting 24 h presumed to be due to focal brain spinal cord or retinal ischemia but without evidence of acute infarction by neuroimaging or pathology or with no imaging performed conform VARC-3 mortality at discharge normally at three to five days postoperatively or within one week postoperatively if discharge is 1 week postoperatively and at three months postoperatively the change in intervention strategy the change in cannulation strategy the change in clamping strategy procedural times and the quality of life at three months postoperatively assessed by EQ-5D and KCCQ
When severe calcification of the ascending aorta is identified preoperatively on multi-slice computed tomography MSCT the operative strategy can be modified if necessary This could possibly prevent stroke or even mortality in the study patients randomized to additional pre-operative MSCT The MSCT will take 5-10 minutes Only low-dose contrast-enhanced CT will be used which results in a very low radiation risk With application of too high dosages of contrast there is a slight chance of kidney insufficiency Furthermore an allergic reaction to contrast could occur However patients with known allergies to contrast and patients with low renal function will be excluded from participation in this trial
The patients receiving a preoperative CT-scan will have to be informed about all incidental findings found on the CT-scan A possible disadvantage is found in the additional costs of a CT-scan but the costs associated with stroke would outweigh the costs of a preoperative CT-scan All patients will receive a DW-MRI before discharge Contra-indications for MRI include pacemaker wires or implantable cardioverter defibrillators ICDs metallic implants cochlearear implants Swan-Ganz catheter claustrophobia and contrast allergy The presence of an aortic valve prosthesis is not a contra-indication for DW-MRI scanning
All patients will be asked to fill out a questionnaire at baseline and within 90 days postoperatively Since this will soon be implemented as part of standard care the latter is not seen as extra burden for the patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None