Acute Kidney Injury, Coronary Artery Disease, Percutaneous Coronary Intervention
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREStandard of care Ultra Low Contrast PCI
PCI using low amounts of contrast media which is standard of care at VCU Medical Center
Sponsors
Guerbet
Virginia Commonwealth University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive patients undergoing elective and urgent (i.e., non-emergent) PCI * Age \>18 years * eGFR \<60 ml/min/1.73 m2 * Angina or equivalent and/or documentation of inducible myocardial ischemia * Presence of =1 coronary stenosis, evaluated \>70% by visual estimation (on a previously performed coronary angiography) or with an FFR =0.80 * ability to provide written informed consent
Exclusion criteria
* Emergent PCI due to either hemodynamic instability, ST-elevation myocardial infarction or sudden cardiac death * PCI on chronic total occlusion * Prior PCI within 3 weeks * Age \>90 years * Left ventricular ejection fraction \<20% * Need for mechanical circulatory support * Pregnancy * Prisoners * Non-English speaking patients * Inability to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Kidney Injury (AKI) | Up to 72 hours after the procedure | Standard laboratory assays related to renal function will be used to identify which, if any, patients develop AKI |
Other
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarction | Up to 30 days after PCI procedure | Number of myocardial infarctions |
| Target lesion revascularization | Up to 30 days after PCI procedure | Number of target-lesion revascularizations |
| Cardiac death | Up to 30 days after PCI procedure | Number of cardiac deaths |
| Pericardial effusion | Up to 30 days after PCI procedure | Number of pericardial effusion |
| new need for dialysis | Up to 30 days after PCI procedure | Number of new patients needing dialysis |
| All-cause mortality | Up to 30 days after PCI procedure | Number of deaths due to any cause |
Countries
United States
Outcome results
None listed