Clinical study protocol for the ARCH project - computational modeling for improvement of outcome after vascular access creation

J Vasc Access. 2011 Oct-Dec;12(4):369-76. doi: 10.5301/JVA.2011.8382.

Abstract

Despite clinical guidelines and the possibility of diagnostic vascular imaging, creation and maintenance of a vascular access (VA) remains problematic: avoiding short- and long-term VA dysfunction is challenging. Although prognostic factors for VA dysfunction have been identified in previous studies, their potential interplay at a systemic level is disregarded. Consideration of multiple prognostic patient specific factors and their complex interaction using dedicated computational modeling tools might improve outcome after VA creation by enabling a better selection of VA configuration. These computational modeling tools are developed and validated in the ARCH project: a joint initiative of four medical centers and three industrial partners (FP7-ICT-224390). This paper reports the rationale behind computational modeling and presents the clinical study protocol designed for calibrating and validating these modeling tools. The clinical study is based on the pre-operative collection of structural and functional data at a vascular level, as well as a VA functional evaluation during the follow-up period. The strategy adopted to perform the study and for data collection is also described here.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Angiography, Digital Subtraction
  • Arteriovenous Shunt, Surgical* / adverse effects
  • Computer Simulation*
  • Europe
  • Hemodynamics
  • Humans
  • Image Processing, Computer-Assisted*
  • Kidney Failure, Chronic / diagnosis
  • Kidney Failure, Chronic / physiopathology
  • Kidney Failure, Chronic / therapy*
  • Magnetic Resonance Angiography
  • Models, Cardiovascular*
  • Predictive Value of Tests
  • Prospective Studies
  • Regional Blood Flow
  • Renal Dialysis*
  • Reproducibility of Results
  • Research Design*
  • Risk Assessment
  • Risk Factors
  • Tomography, X-Ray Computed
  • Ultrasonography, Doppler, Duplex
  • Upper Extremity / blood supply*