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The PI is leaving the institution
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| Name | Class |
|---|---|
| Guerbet | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active research group | Patients undergoing intravascular imaging guided, low contrast PCI procedure as part of standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care Ultra Low Contrast PCI | Procedure | PCI using low amounts of contrast media which is standard of care at VCU Medical Center |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Kidney Injury (AKI) | Standard laboratory assays related to renal function will be used to identify which, if any, patients develop AKI | Up to 72 hours after the procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death | Number of cardiac deaths | Up to 30 days after PCI procedure |
| Myocardial infarction | Number of myocardial infarctions | Up to 30 days after PCI procedure |
Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled to undergo a PCI.
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Azzalini, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| Target lesion revascularization | Number of target-lesion revascularizations | Up to 30 days after PCI procedure |
| All-cause mortality | Number of deaths due to any cause | Up to 30 days after PCI procedure |
| Pericardial effusion | Number of pericardial effusion | Up to 30 days after PCI procedure |
| new need for dialysis | Number of new patients needing dialysis | Up to 30 days after PCI procedure |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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