Hemodynamic Effects Of Impella On Renal Circulation And Risk Of CA-AKI Among Patients Undergoing … (NCT04928118) | Clinical Trial Compass
WithdrawnNot Applicable
Hemodynamic Effects Of Impella On Renal Circulation And Risk Of CA-AKI Among Patients Undergoing Protected PCI
Stopped: PI may be leaving the institution
0Started 2022-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
* 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%
Exclusion Criteria:-
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.