Evaluation of Advanced US Tools in Assessing Allograft Complications

Completed

• Conditions: Complications; Renal Failure; Chronic Kidney Diseases; Renal Artery Stenosis; Failure,Kidney; Fibrosis
• Interventions: Device: 3D imaging

• Registration Number: NCT04423458
• Lead Sponsor: Imperial College London

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-09
• Study Start: 2022-01-04
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transplanted kidney	3D imaging	No intervention is required. Routine Doppler assessment + 3D scan + Shear wave elastography + MicrFlow Imaging will be immediately recorded afterwards

Primary Outcome Measures

Name	Time	Method
Peak systolic velocity (cm/s).	12 weeks	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
Resistive Index (RI).	12 weeks	An RI less than 0.7 to 0.8 is considered normal, more than that it is indicator of transplant dysfunction.
Peak systolic velocity ratio (PSVR).	12 weeks	High velocity flow at the stenosis site divided by a reference velocity (normal before stenosis)

Secondary Outcome Measures

Name	Time	Method
Volumetric stenosis.	12 weeks	Plaque volume is calculated automatically with the aid of software with a package of 3D laptop.
3D GSM.	12 weeks	Plaque volume is calculated automatically with the aid of software with a package of 3D laptop.

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, United Kingdom