An observational study in Acute Kidney Injury, Coronary Artery Disease and Percutaneous Coronary Intervention, sponsored by Virginia Commonwealth University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-04.
Sponsored by Virginia Commonwealth University · Observational
The purpose of this study is to compare the outcomes of Percutaneous Coronary Intervention (PCI) in patients with chronic kidney disease (CKD) using smaller doses of contrast dye that are validated as being at low risk of causing injury to the kidneys, with the larger doses that are traditionally used contemporary practice.
This study will evaluate whether using lower doses of contrast dye leads to lower rates of kidney injury compared to current standard of care. In particular, effort will be taken to maintain the total amount of contrast dye below a scientifically-validated threshold calculated on the basis of each participant renal function. Participants will already be scheduled to undergo a PCI. Because a smaller amount of contrast dye will be used, an intravascular ultrasound (IVUS) will be used to help the doctors see and open the blockages in participant's coronary arteries. IVUS is already used to optimize PCI results, but will be used more extensively in this case. The amount of contrast dye received will be tailored on each participant kidney function. Prospectively enrolled patients will be matched with historical controls who underwent PCI with non-intravascular imaging based approach.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
Browse Acute Kidney Injury studies →Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients scheduled to undergo a PCI.
Exclusion Criteria:
Patients undergoing intravascular imaging guided, low contrast PCI procedure as part of standard care
Procedure: Standard of care Ultra Low Contrast PCI
PCI using low amounts of contrast media which is standard of care at VCU Medical Center
Acute Kidney Injury (AKI)
Standard laboratory assays related to renal function will be used to identify which, if any, patients develop AKI
Time frame: Up to 72 hours after the procedure
Cardiac death
Number of cardiac deaths
Time frame: Up to 30 days after PCI procedure
Myocardial infarction
Number of myocardial infarctions
Time frame: Up to 30 days after PCI procedure
Target lesion revascularization
Number of target-lesion revascularizations
Time frame: Up to 30 days after PCI procedure
All-cause mortality
Number of deaths due to any cause
Time frame: Up to 30 days after PCI procedure
Pericardial effusion
Number of pericardial effusion
Time frame: Up to 30 days after PCI procedure
new need for dialysis
Number of new patients needing dialysis
Time frame: Up to 30 days after PCI procedure
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University