Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
PI may be leaving the institution
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Abiomed Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Patients undergoing Percutaneous Coronary Intervention (PCI) are exposed to the risk of suffering from a damage to the kidneys which goes under the name of Contrast-Associated Acute Kidney Injury (CA-AKI), which is more common if the subject has advanced heart or kidney disease. Up to 1 high risk patient in 3 can suffer from CA-AKI. Impella is a pump which sustain the heart in the course of PCI in high risk individuals. Incidentally, Impella was shown to also reduce the incidence of CA-AKI. The reason why Impella protects the kidneys is not currently known. The investigators aim at understanding it through measurements of kidney blood flow and metabolism.
Contrast-associated acute kidney injury (CA-AKI) is among the major determinants of morbidity after percutaneous coronary intervention (PCI). Patients undergoing complex, high-risk indicated procedures (CHIP) are exposed to an increased risk of CA-AKI. Recent observational data suggested that mechanical circulatory support (MCS) with Impella in the course of CHIP PCI, i.e. Impella-protected PCI, may abate the risk of CA-AKI. A direct effect of MCS in improving renal perfusion has been postulated, but mechanistic evidence on the pathophysiologic effects of Impella on kidney hemodynamics is lacking. The investigators hypothesize that such improved renal outcomes during Impella protected PCI are attributable to increased blood flow as well as increased oxygen delivery to the kidneys granted by MCS. The aim of the present study is to fully characterize the renal hemodynamics as well as renal oxygen delivery and consumption during Impella-protected PCI using state-of-the-art invasive measurements, and to correlate those with functional magnetic resonance imaging of the kidney.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Impella protected Percutaneous coronary intervention (PCI) | Patients undergoing Impella protected PCI as deemed necessary by interventional cardiologist - VCU Medical Center case based standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluate the blood flow and pressure into kidneys | Other | Renal artery pressure and flow measures will be obtained using dedicated equipment positioned into the renal artery under fluoroscopic guidance. A pulmonary artery catheter will be used to measure the pressure inside participant's renal vein and to collect small blood samples to measure oxygen content. |
| Measure | Description | Time Frame |
|---|---|---|
| Renal blood flow (RBF) | thermodilution will be used to measure patterns of RBF in milliliters per minute | during PCI up to 5 hours |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Acute Kidney Injury (AKI) | Change in creatine will be used to identify AKI | up to 72 hours after PCI |
| Anatomical changes | Pre and post-procedural kidney magnetic resonance imaging (MRI) will be used to explore any changes in acute renal ischemia due to the procedure |
Inclusion Criteria:
Impella-protected PCI selection criteria according to Virginia Commonwealth University (VCU) Complex PCI Program
Complexity features
Exclusion Criteria:-
Not provided
Not provided
Not provided
Patients who are scheduled to undergo Impella assisted PCI procedure
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Azzalini, MD | Virginia Commonwealth University | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 3 days |
| Renal oxygen delivery (ROD) | ROD is defined as O2 content (CaO2) (RBF x CaO2). Blood samples during the procedure will be used to observe the patterns. | during PCI up to 5 hours |
| Renal oxygen consumption (ROC) | ROC is defined as CaO2 and renal vein oxygen content (CvO2) as RBF x (CaO2 - CvO2). Blood samples during the procedure will be used to observe the patterns. | during PCI up to 5 hours |
| Renal oxygen extraction (ROE) | ROE is defined as CaO2 and CvO2 as (CaO2 - CvO2)/CaO2. Blood samples during the procedure will be used to observe the patterns. | during PCI up to 5 hours |
| Renal vascular resistance (RVR) | RVR will be calculated using mean arterial pressure (MAP) and renal vein pressure (RVP) as (MAP - RVP)/RBF. | during PCI up to 5 hours |