Evaluation of Advanced US Tools in Assessing Allograft Complications

NCT04423458 | Completed

• 1 other identifier: 848 -20HH6053
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

3D Ultrasound; US elastography; US MFI; Ultrasound; MRI; CT

Outcome Measures

Primary Outcomes (3)

• 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

  12 weeks

• Peak systolic velocity ratio (PSVR).

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

  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.

  12 weeks

Secondary Outcomes (2)

• Volumetric stenosis.

  12 weeks

• 3D GSM.

  12 weeks

Study Arms (1)

Transplanted kidney

No intervention is required. Routine Doppler assessment + 3D scan + Shear wave elastography + MicrFlow Imaging will be immediately recorded afterwards

Device: 3D imaging

Interventions

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.

Transplanted kidney

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients having /had kindey transplant

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency; Renal Insufficiency, Chronic; Renal Artery Obstruction; Fibrosis

Interventions

Imaging, Three-Dimensional

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mohammed Aslam, PhD

  Academic Supervisor

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: January 4, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)