Skip to main content
OpenTrials
Completed

NCT Number: NCT04423458

Evaluation of Advanced US Tools in Assessing Allograft Complications

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Failure Arterial Occlusive Diseases Cardiovascular Diseases Chronic Disease Chronic Kidney Diseases Complications Disease Attributes Failure,Kidney Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Artery Obstruction Renal Artery Stenosis Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College London

London, W12 0HS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 18 years.
  • Tx patients.
  • Gender.

Exclusion criteria

  • Prisoners.
  • Patients < 18 years.
  • Pregnant women

Treatment and study plan

3D imaging

Device

The study will focus on the accuracy of ultrasound technology in assessing renal transplants.

The entire assessment should not take more than 25 minutes.

Primary outcomes

  1. Peak systolic velocity (cm/s).

    Time frame: 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

  2. Peak systolic velocity ratio (PSVR).

    Time frame: 12 weeks

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

  3. Resistive Index (RI).

    Time frame: 12 weeks

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

Secondary outcomes

  1. Volumetric stenosis.

    Time frame: 12 weeks

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

  2. 3D GSM.

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

The Evaluation of Advanced Ultrasonography Applications in the Assessment of Transplanted Kidney Complications

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2020
Registry last updated
Feb 8, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.