Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411353
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-08
Brief Title:
Blood Flow Conditions and Sounds in AVFs
Sponsor:
Mario Negri Institute for Pharmacological Research
Organization:
Mario Negri Institute for Pharmacological Research
Study Overview
Official Title:
The Relationship Between Blood Flow Conditions and Sounds in Arteriovenous Fistulae for Hemodialysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APOLLO
Brief Summary:
This is a prospective non-pharmacological interventional study aimed at investigating the relationship between the blood flow condition and the arteriovenous fistula AVF sound with the ultimate aim of predicting the AVF clinical in patients with end-stage renal disease ESRD who require the creation of a vascular access for extracorporeal circulation
Detailed Description:
The native arteriovenous fistula AVF is the lifeline for patients on hemodialysis treatment but it is still affected by high non-maturation and early failure rates requiring in most of the cases the creation of a new vascular access
Despite the exact mechanism underlying stenosis development and consequent AVF failure remains tentative there is a general consensus that hemodynamic conditions play a key role The hemodynamic conditions can be studied using computational fluid dynamic simulations CFD advanced computational techniques that allow to simulate blood flowing in virtual 3D models generated from medical images The current gold standard in the clinical studies with CFD is to obtain reliable 3D AVF models from non-contrast enhanced MRI and our group developed a novel MRI protocol for this purpose However recent studies performed by other groups suggest that US technique can also provide accurate and reliable models and the hit on the market and the tUS Piur Device which was recently made available to the investigators research group offers new avenues for non-invasive and inexpensive 3D patient-specific AVF model generation Previous computational fluid dynamics investigations inside patient-specific AVF models conducted by the investigators revealed transitional turbulent-like flow in the vein In particular the investigators evaluated the venous surface areas occupied by high values of the Oscillatory Shear Index OSI a well-accepted hemodynamic metric for the identification of disturbed flow conditions and they found that wide areas of the venous segment of AVFs are characterized by OSI 01 More recently by using fluid structure interaction simulations the investigators have shown that such turbulent-like blood flow conditions cause the venous wall to vibrate at high frequencies and that wall vibrations phenotypically collocate with typical regions of stenosis formation The investigators hypothesis is that flow-induced vibrations are transmitted to the skin surface of the patient and then result in those palpable thrills and audible bruits that over the years nurses and nephrologists got used to qualitatively evaluate using their stethoscopes However up to now sound evaluation has only been qualitative and therefore very subjective but it may provide a strong indication of aberrant hemodynamic conditions and could have a potential as a non-invasive and unexpensive surveillance method
Therefore studies aimed at clarifying the relationship between the blood flow conditions and the AVF sound will help advancing the knowledge in the field providing indications on the role of hemodynamics in AVF failure and bringing out novel methods such as sound analysis for AVF surveillance
Despite the exact mechanism underlying stenosis development and consequent AVF failure remains tentative there is a general consensus that hemodynamic conditions play a key role The hemodynamic conditions can be studied using computational fluid dynamic simulations CFD advanced computational techniques that allow to simulate blood flowing in virtual 3D models generated from medical images The current gold standard in the clinical studies with CFD is to obtain reliable 3D AVF models from non-contrast enhanced MRI and our group developed a novel MRI protocol for this purpose However recent studies performed by other groups suggest that US technique can also provide accurate and reliable models and the hit on the market and the tUS Piur Device which was recently made available to the investigators research group offers new avenues for non-invasive and inexpensive 3D patient-specific AVF model generation Previous computational fluid dynamics investigations inside patient-specific AVF models conducted by the investigators revealed transitional turbulent-like flow in the vein In particular the investigators evaluated the venous surface areas occupied by high values of the Oscillatory Shear Index OSI a well-accepted hemodynamic metric for the identification of disturbed flow conditions and they found that wide areas of the venous segment of AVFs are characterized by OSI 01 More recently by using fluid structure interaction simulations the investigators have shown that such turbulent-like blood flow conditions cause the venous wall to vibrate at high frequencies and that wall vibrations phenotypically collocate with typical regions of stenosis formation The investigators hypothesis is that flow-induced vibrations are transmitted to the skin surface of the patient and then result in those palpable thrills and audible bruits that over the years nurses and nephrologists got used to qualitatively evaluate using their stethoscopes However up to now sound evaluation has only been qualitative and therefore very subjective but it may provide a strong indication of aberrant hemodynamic conditions and could have a potential as a non-invasive and unexpensive surveillance method
Therefore studies aimed at clarifying the relationship between the blood flow conditions and the AVF sound will help advancing the knowledge in the field providing indications on the role of hemodynamics in AVF failure and bringing out novel methods such as sound analysis for AVF surveillance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None