Contrast-induced Acute Kidney Injury (CI-AKI)NCT04928118
Hemodynamic Effects Of Impella On Renal Circulation And Risk Of CA-AKI Among Patients Undergoing Protected PCI
An observational study of Contrast-induced Acute Kidney Injury (CI-AKI), run by Virginia Commonwealth University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-induced Acute Kidney Injury (CI-AKI)
- What is being tested?
- Evaluate the blood flow and pressure into kidneys
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are scheduled to undergo Impella assisted PCI procedure
Who may be able to join
- Impella-protected PCI selection criteria according to Virginia Commonwealth University (VCU) Complex PCI Program
- Left ventricular ejection fraction (LVEF) ≤35% and ≥1 complexity feature
- LVEF ≤45% and estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2 and ≥1 complexity feature
- LVEF ≤45% and eGFR 31-45 ml/min/1.73 m2 and ≥2 complexity features
- Complexity features
- Planned treatment of ≥2 vessels
Show all 13Show fewer
- Left main PCI
- Bifurcation intervention with 2-stent strategy
- Planned use of atherectomy (rotational, orbital, laser)
- Chronic total occlusion PCI
- PCI on last remaining vessel
- LVEDP >18 mmHg
- Cardiac index <2.0 l/min/m2 or pulmonary artery O2 saturation <55%
Who cannot join
- Pregnancy or lactation
- Presence of non-MRI compatible implanted medical device
- Known absolute contraindication to Impella insertion, e.g. severe peripheral arterial disease, left ventricular thrombus, aortic mechanical prosthesis, or severe aortic valve stenosis
- Chronic hemodialysis before the index procedure
- Status post-renal transplant
- Prisoners
About this study
Official title: Characterization Of The Hemodynamic Effects Of Impella On Renal Blood Flow And Oxygen Delivery And Risk Of Contrast-Associated Acute Kidney Injury Among Patients Undergoing Protected Percutaneous Coronary Intervention
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.
Read the detailed description
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.
- Being tested
- Evaluate the blood flow and pressure into kidneys
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate the blood flow and pressure into kidneysOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Evaluate the blood flow and pressure into kidneys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal blood flow (RBF)
thermodilution will be used to measure patterns of RBF in milliliters per minute
Measured: during PCI up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study startJan 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: PI may be leaving the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast-induced Acute Kidney Injury (CI-AKI)Studies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Abiomed Inc.
- Responsible party
- Sponsor
- Investigators
- Lorenzo Azzalini, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928118
- Sponsor's protocol ID
- HM20021800
- Status last verified
- Jan 2022
- First submitted
- 26 May 2021
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization Of The Hemodynamic Effects Of Impella On Renal Blood Flow And Oxygen Delivery And Risk Of Contrast-Associated Acute Kidney Injury Among Patients Undergoing Protected Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04928118
- Acronym / sponsor ID
- HM20021800
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI may be leaving the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Abiomed Inc.
- Study start
- Jan 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Impella protected Percutaneous coronary intervention (PCI) | – | Other: Evaluate the blood flow and pressure into kidneysPatients undergoing Impella protected PCI as deemed necessary by interventional cardiologist - VCU Medical Center case based standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled to undergo Impella assisted PCI procedure
Key inclusion criteria (13 listed)
- Impella-protected PCI selection criteria according to Virginia Commonwealth University (VCU) Complex PCI Program
- Left ventricular ejection fraction (LVEF) ≤35% and ≥1 complexity feature
- LVEF ≤45% and estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2 and ≥1 complexity feature
- LVEF ≤45% and eGFR 31-45 ml/min/1.73 m2 and ≥2 complexity features
- Complexity features
Key exclusion criteria (6 listed)
- Pregnancy or lactation
- Presence of non-MRI compatible implanted medical device
- Known absolute contraindication to Impella insertion, e.g. severe peripheral arterial disease, left ventricular thrombus, aortic mechanical prosthesis, or severe aortic valve stenosis
- Chronic hemodialysis before the index procedure
- Status post-renal transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluate the blood flow and pressure into kidneysRenal 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. | Other | Impella protected Percutaneous coronary intervention (PCI) |
Primary outcome
Renal blood flow (RBF)
Time frame: during PCI up to 5 hours
thermodilution will be used to measure patterns of RBF in milliliters per minute
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Contrast-induced Acute Kidney Injury (CI-AKI)
Recruiting
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
Not yet recruiting
The Effect of Hydration on the Prevention of CI-AKI in STEMI Patients Undergoing Primary PCI (Hydro-AKI Trial)
Contrast-Induced Acute Kidney Injury in ST-Segment Elevation Myocardial Infarction, Contrast Induced AKI
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Azzalini, MD principal investigator
Virginia Commonwealth University
Questions about this trial
What is this clinical trial studying?
An observational study of Contrast-induced Acute Kidney Injury (CI-AKI), run by Virginia Commonwealth University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal blood flow (RBF) (time frame: during PCI up to 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.