A.O. Papa Giovanni XXIII - U.O. Nefrologia e Dialisi
Bergamo, 20147, Italy
Location status: Recruiting
NCT Number: NCT06411353
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Bergamo, 20147, Italy
Location status: Recruiting
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 > 0.1. 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-contrast enhanced acquisitions will be performed using a whole-body MRI scanner operating at 1.5 Tesla or greater.
A complete assessment of the AVF vessels is performed using advanced 3D US procedures.
Time frame: At each established study visit (i.e., at day 14, at months 3, 6, 12, 24)
LHPR: ratio between the amplitude of maximum peak in the range of low-frequency (100-250 Hz) and the amplitude of the maximum peak at high frequency (500-750 Hz). OSI: oscillatory shear index, common metric for disturbed blood flow.
Contact information is provided by the study sponsor or research team.
Mario Negri Institute for Pharmacological Research
Other
The Relationship Between Blood Flow Conditions and Sounds in Arteriovenous Fistulae for Hemodialysis
Acronym: APOLLO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04698512
Arteriovenous Fistula, Arteriovenous Malformations
Singapore
View Trial DetailsNCT06001827
Arteriovenous Fistula, Arteriovenous Malformations
Bullhead City, Arizona, United States
View Trial DetailsNCT04399941
Chronic Disease, Constriction, Pathologic
Boston, Massachusetts, United States
View Trial DetailsNCT02513303
Arteriovenous Fistula, Arteriovenous Malformations
Huntsville, Alabama, United States
View Trial Details