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Trial record 15 of 20 for:    Cystatin | Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

Safety of Iodinated Contrast in Liver Transplant Candidates With Decreased Renal Function Undergoing Coronary CT Angiography

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ClinicalTrials.gov Identifier: NCT03806725
Recruitment Status : Not yet recruiting
First Posted : January 16, 2019
Last Update Posted : April 9, 2019
Sponsor:
Collaborators:
Domenico Mastrodicasa
Xingxing Shelley Cheng
Aijaz Ahmed
Jane Cheun Tan
Virginia Hinostroza
Koen Nieman
William F Fearon
Lior Molvin
Martin J Willemink
Aya Kino
Dominik Fleischmann
Information provided by (Responsible Party):
Martin Koci, MD, Stanford University

Brief Summary:
This study evaluates the safety of iodinated contrast medium administered to liver transplant candidates with decreased renal function undergoing coronary CT angiography. Incidence of post-contrast acute kidney injury in liver transplant candidates with decreased renal function and normal renal function will be compared.

Condition or disease Intervention/treatment
Acute Kidney Injury Renal Insufficiency, Chronic Contrast-induced Nephropathy Liver Transplantation Contrast Media Diagnostic Test: Intravenous administration of iodinated contrast medium for coronary CT angiography

Detailed Description:

Low osmolar non-ionic contrast medium (LOCM) is routinely used for contrast-enhanced computed tomography (CT) including coronary computed tomography angiography (CCTA).

This study evaluates the effect of LOCM on liver transplant candidates with normal and decreased renal function undergoing CCTA. Incidence of post-contrast acute kidney injury (PC-AKI) will be compared between the two groups before and after contrast medium exposure.

LOCM is a potential cause of PC-AKI, especially in vulnerable population with decreased renal function. According to the American College of Radiology (ACR) manual on contrast media, however, many published studies on PC-AKI in the past have been heavily contaminated by bias and conflation. More recent studies do not confirm a high risk of contrast induced nephropathy.

End stage liver disease patients with normal renal function do not seem to be at a higher risk of developing PC-AKI. Only limited data reporting a low incidence of PC-AKI after contrast-enhanced CT in patients with liver cirrhosis and concomitant decreased renal function exists. Proof of low PC-AKI in this specific population would allow to redirect patients from invasive catheterization to CCTA as their cardiac clearance before transplantation. This study will prospectively investigate the incidence of PC-AKI in this specific at-risk population.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Performance and Iodinated Contrast Safety of Coronary Computed Tomography Angiography in Liver Transplant Candidates With Decreased Renal Function
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : January 22, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
LTx eGFR>=60
Liver transplant candidates with renal function defined by eGFR above or equal to 60 ml/min/1.73m2, eGFR is determined by Cystatin C measurment.
Diagnostic Test: Intravenous administration of iodinated contrast medium for coronary CT angiography
Administration of iodinated contrast medium for coronary CT angiography

LTx eGFR<60

Liver transplant candidates with decreased renal function.

Defined by eGFR less than 60 ml/min/1.73m2, eGFR is determined by Cystatin C measurment.

Diagnostic Test: Intravenous administration of iodinated contrast medium for coronary CT angiography
Administration of iodinated contrast medium for coronary CT angiography




Primary Outcome Measures :
  1. Post-contrast acute kidney injury [ Time Frame: Within 5 days after contrast medium exposure. ]
    Incidence of acute kidney injury after iodine contrast medium exposure.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Liver transplant candidates in evaluation process undergoing cardiac clearance
Criteria

Inclusion Criteria:

- Liver transplant candidate, age > 21 referred for coronary CT angiography, medium-risk patient for coronary artery disease

Exclusion Criteria:

  • Liver transplant candidates who are at low-risk for coronary artery disease and therefore do not need coronary CT angiography or invasive catheterization
  • Liver transplant candidates who are at high-risk for coronary artery disease and are referred directly to invasive catheterization
  • Candidates with chronic kidney disease stage 4, with eGFR <30 ml/min/1.73m2
  • Known or suspected allergy to standard iodine contrast medium

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806725


Contacts
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Contact: Martin Koci, MD +1 650 943 3013 mkoci@stanford.edu
Contact: Domenico Mastrodicasa, MD +1 650 650 0001 mastro@stanford.edu

Locations
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United States, California
Stanfor University Not yet recruiting
Stanford, California, United States, 94305
Contact: Martin Koci, MD    650-943-3013    mkoci@stanford.edu   
Contact: Domenico Mastrodicasa, MD    +1 650 650 0001    mastro@stanford.edu   
Sponsors and Collaborators
Stanford University
Domenico Mastrodicasa
Xingxing Shelley Cheng
Aijaz Ahmed
Jane Cheun Tan
Virginia Hinostroza
Koen Nieman
William F Fearon
Lior Molvin
Martin J Willemink
Aya Kino
Dominik Fleischmann

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Responsible Party: Martin Koci, MD, MD, Stanford University
ClinicalTrials.gov Identifier: NCT03806725     History of Changes
Other Study ID Numbers: IRB-45901
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Martin Koci, MD, Stanford University:
Contrast-induced Nephropathy
Contrast-induced acute kidney injury
Coronary computed tomography angiography
Additional relevant MeSH terms:
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Kidney Diseases
Acute Kidney Injury
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases