angiography
ProcedureCoronary angiography with less than 20cc of contrast materials
NCT Number: NCT05906758
The aim of this study is to evaluate the safety of ultra-low contrast coronary angiography in patients with pre-existing acute kidney injury.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Phase 3
Tulane University Medical Center, New Orleans, Louisiana, United States
The study is a non-inferiority open-label randomized controlled trial. Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial. Once indication for invasive coronary angiography is determined, patients will be randomized to immediate angiography or to delayed angiography after renal function stabilizes. Immediate angiography will be performed within 24 of enrollment. 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.
Definitions: AKI is defined as an increase in serum creatinine by ≥50% from baseline within 7 days or an increase in serum creatinine by ≥0.3 mg/dl within 2 days. CIN is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Coronary angiography with less than 20cc of contrast materials
Time frame: Within 7 days
CIN is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value. The investigators will measure the incidence of CIN by the increase in serum creatinine to see if the incidence will be the same in both arms whether the patient received the immediate angiography or if it was delayed until kidney function has been stabilized.
Time frame: Within 7 days
The investigators will measure serum creatinine at 24, 48 hours and at 1 week to measure if the occurrence of CIN will happen earlier in 1 arm than the other
Time frame: Within 7 days
The investigators will measure the incidence of renal replacement therapy by monitoring if the patient will undergo dialysis within 7 days post angiography
Contact information is provided by the study sponsor or research team.
Tulane University
Other
Randomized Controlled Trial of Ultra-Low Contrast Coronary Angiography During Acute Kidney Injury (AKI)
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.
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