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Procedure
Low-Contrast Angiography for Acute Kidney Injury
Phase 3
Waitlist Available
Led By Zach Rozenbaum, MD
Research Sponsored by Tulane University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 7 days
Awards & highlights
Study Summary
This trial tests if it's safe to do coronary angiography in patients with acute kidney injury.
Who is the study for?
This trial is for hospitalized patients who have acute kidney injury (AKI) either at the time of admission or develop it during their stay and need a heart blood vessel check called invasive coronary angiography. It's not for those with stable kidney function, contraindications other than AKI, urgent heart procedures that can't wait a week, planned or current dialysis around the procedure time, recent contrast media use, pregnant women, prisoners, under 18s or those unable to consent.Check my eligibility
What is being tested?
The study tests the safety of using an ultra-low amount of dye in coronary angiography—a procedure to visualize heart vessels—in patients with acute kidney injury. The goal is to see if this method reduces further harm to kidneys while still providing clear images for diagnosis.See study design
What are the potential side effects?
While specific side effects are not listed here, generally angiography can cause bleeding at the catheter site, irregular heartbeat or allergic reactions to the dye used. This study aims to minimize risks by using less dye.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was admitted to the hospital with AKI or developed it during my stay and need a heart artery exam.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in incidence of Contrast Induced Nephropathy (CIN)
Secondary outcome measures
Incidence of earlier occurrence of CIN
Incidence of renal replacement therapy at up to 7 days post-angiography
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Immediate intervention armActive Control1 Intervention
Immediate angiography will be performed within 24 hours of enrollment. Omnipaque contrast will be administered. Serum creatinine will be collected on enrollment, within 6 hours before coronary angiography, and at 24h, 48h and 1-week after the angiography, as expected in common practice. Pre- and post-hydration administration will be at the discretion of the treating physician. In case percutaneous coronary intervention is indicated it will be schedule for 7 days after angiography.
Group II: Delayed intervention armPlacebo Group1 Intervention
Delayed angiography will be performed after kidney function stabilizes.
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Who is running the clinical trial?
Tulane UniversityLead Sponsor
115 Previous Clinical Trials
226,470 Total Patients Enrolled
Zach Rozenbaum, MDPrincipal InvestigatorTulane University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function has been stable or improving in the last 24 hours.I have not had contrast media for tests 7 days before or 6 days after my heart imaging test.I am not pregnant, imprisoned, under 18, cognitively impaired, and I can consent.I need a heart procedure that can't wait a week.I need dialysis before or after my heart vessel check if planned in advance.You are not able to undergo invasive coronary angiography for reasons other than acute kidney injury.I was admitted to the hospital with AKI or developed it during my stay and need a heart artery exam.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate intervention arm
- Group 2: Delayed intervention arm
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the study protocol encompass senior citizens?
"According to the regulations of this experiment, individuals between 18 and 100 years old are eligible for enrollment."
Answered by AI
Who is eligible to join this medical research experiment?
"Eligibility criteria for this clinical trial requires that participants have been diagnosed with acute kidney injury and are within the ages of 18 to 100. 32 individuals will be accepted in total."
Answered by AI
Are investigators currently recruiting participants for this trial?
"As documented on clinicaltrials.gov, this trial is no longer actively recruiting patients. It was posted on July 1st 2023 and the most recent update occurred June 7th 2023. Although there are currently 139 other trials searching for participants, this specific study has closed its recruitment phase."
Answered by AI
Has the Immediate intervention arm received sanction from the FDA?
"Analysis conducted by Power rated Immediate Intervention arm as a 3, indicating that it has been clinically proven effective and the safety profile is well-established."
Answered by AI
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