Monitoring Renal Blood Flow With Contrast Enhanced Ultrasound During Coronary Angiogram
Public ClinicalTrials.gov record NCT01544036. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Monitoring Renal Blood Flow Using Contrast Enhanced Ultrasound in Predicting Acute Kidney Injury After Exposure to Iodinated Contrast Agent
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Contrast induced nephropathy (CN) is a common cause of acute kidney injury and is associated with increased morbidity and mortality and healthcare cost. Iodinated contrast media (ICM) induce kidney injury through vasoconstriction and ischemia as well as direct tubular toxicity. Older subjects, individuals with preexisting kidney disease, diabetes, hypotension, and those exposed to higher volumes of ICM are at higher risks for CN. Within the last several years, multiple strategies have been used in clinical studies to reduce the risk of CN in high risk individuals with inconsistent results. In general, it is agreed that volume expansion is effective in reducing the risk. However, no study has looked at changes in renal blood flow (RBF) in response to volume expansion or after exposure to ICM to investigate its relationship with occurrence of CN. In this proposal, up to 125 individuals with preexisting kidney disease as evidenced by an estimated glomerular filtration rate (eGFR) between 30 - 60 ml/min/1.73 m2 and up to 25 individuals with normal renal function (total of up to 150 individuals) who are scheduled for coronary angiography will be studied. Each individual will have serial measurements of RBF; at baseline, after volume expansion with normal saline, and after exposure to ICM, using the novel technique of contrast enhanced ultrasound (CEU). The investigators will investigate the utility of monitoring RBF with CEU in predicting the occurrence of CN (a rise of \> 0.3 mg/dL or 25% in baseline serum creatinine 48 hours after exposure to ICM) after adjusting for other known risk factors in the group of subjects with reduced GFR. The investigators will also examine the correlation between RBF changes and other urinary and serum biomarkers of kidney injury in this group. Up to 25 individuals with a normal kidney function will be studied in a separate part of the study in which the accuracy of CEU based measurements of RBF will be compared to the RBF and blood flow velocity obtained simultaneously using a Doppler flow probe placed directly inside the main renal artery during coronary angiogram procedure. Total to enroll = 150.
Study identification
- NCT ID
- NCT01544036
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2012
- Primary completion
- Jan 31, 2014
- Completion
- Not listed
- Last update posted
- Dec 18, 2013
Started 2012
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Virginia Health System | Charlottesville | Virginia | 22908 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01544036, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 18, 2013 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01544036 live on ClinicalTrials.gov.