Evaluation of Advanced US Tools in Assessing Allograft Complications

Imperial College London80 enrolled

Overview

This study evaluates the role of advanced US technology in assessing renal transplants as screening tools such as 3D Ultrasound, Ultrasound SWE, and MFI besides current ultrasound conventional metheds.

This study will focus on monitoring renal after transplantation using all US advanced technology. Aim one will concentrate on the 3D US in assessing artery stenosis (TRAS) compared to the gold standard. Aim two focuses on will concentrate on Ultrasound elastography in assessing renal stiffness. Aim three will compare US colour modes such as PD, CD and MFI to assess renal perfusion in three groups. Duration: 18 Months; participants will have a patient information sheet; once they are happy to participate, consent will be obtained. Study data will be entered into a database encrypted and stored in the department. Only the study principal investigator (PI) will know the study database password.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Renal Failure Chronic Kidney Diseases Failure,Kidney Renal Artery Stenosis Fibrosis Complications

Interventions

3D imagingDEVICE

The study will focus on the accuracy of ultrasound technology in assessing renal transplants. The entire assessment should not take more than 25 minutes.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

INCLUSION CRITERIA * Patients ≥ 18 years. * Tx patients. * Gender. EXCLUSION CRITERIA * Prisoners. * Patients \< 18 years. * Pregnant women

Locations (1)

Imperial College London

London, United Kingdom

Outcomes

Primary Outcomes

Peak systolic velocity (cm/s).

Pean of the blood flow velocities in the artery/ vein peak systolic velocity ≥200 cm/s velocity difference between pre- and post-stenotic segments of 2:1

Time frame: 12 weeks

Peak systolic velocity ratio (PSVR).

High velocity flow at the stenosis site divided by a reference velocity (normal before stenosis)

Time frame: 12 weeks

Resistive Index (RI).

An RI less than 0.7 to 0.8 is considered normal, more than that it is indicator of transplant dysfunction.

Time frame: 12 weeks

Secondary Outcomes

Volumetric stenosis.

Plaque volume is calculated automatically with the aid of software with a package of 3D laptop.

Time frame: 12 weeks

3D GSM.

Plaque volume is calculated automatically with the aid of software with a package of 3D laptop.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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