Acute Kidney Injury, Contrast Induced Nephropathy, Coronary Angiography, Heart Failure, Percutaneous Coronary Intervention
Conditions
Keywords
Contrast-induced acute kidney injury, Congestive heart failure, Contrast induced nephropathy, Coronary angiography, Percutaneous coronary intervention, Coronary artery disease, Remote ischemic conditioning, acute coronary syndrome, Acute kidney injury, Major adverse kidney events, Ischemic preconditioning
Brief summary
This is a prospective, double-blind, sham-controlled, multicenter, randomized clinical trial is to study the effects of remote ischemic preconditioning on contrast-associated acute kidney injury, functional capacity, and major adverse kidney events in in patients with congestive heart failure undergoing cardiac catheterization and/or percutaneous coronary intervention.
Detailed description
The RICH Trial is a prospective, multicenter, randomized clinical trial to determine the effect of remote ischemic preconditioning on contrast associated acute kidney injury, and to characterize the effect of remote ischemic preconditioning on brain natriuretic peptide, functional capacity at one month, and major adverse kidney events (persistent renal dysfunction, renal replacement therapy, and death) at three months in patients with congestive heart failure with reduced left ventricular ejection fraction undergoing coronary angiography and/or percutaneous coronary intervention.
Interventions
DEVICERemote ischemic preconditioning
3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
DEVICESham remote ischemic conditioning
3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Eligible patients will be randomized to RIPC or sham-RIPC.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years * Diagnosis of heart failure with reduced LVEF \<50% * Pre-procedure intravenous normal saline fluid restriction status * Society for Cardiovascular Angiography and Interventions (SCAI) AKI risk score (\>1%) * Referral for coronary angiogram and/or PCI * Suspected stable coronary artery disease or acute coronary syndrome
Exclusion criteria
* Inability to give informed consent * Unstable BP (SBP \> 200 or \<80 mmHg) at the time of enrolment * Upper limb peripheral arterial disease * Unavailability of at least one arm for RIPC/Sham-RIPC application * Kidney transplant * Renal disease requiring dialysis * Prior exposure to contrast media within 72hrs preceding coronary angiography * Pregnancy * Prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast-associated acute kidney injury | 24 and 48 hours time points | The investigators define contrast-associated acute kidney injury as a relative increase in serum creatinine of 0.3mg/dl compared with initial creatinine at 48 hours time point after coronary angiography and/or PCI. The will obtain levels of serum creatinine at baseline, then at 24 and 48 hours time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 minute walk distance | 1 month | At one month follow-up, 6 minute walk test will be used to determine total distance walked in 6 minutes. |
| Major adverse kidney events | 3 months | Persistent renal dysfunction, renal replacement therapy, and death will be assessed at 3 months (90 days) to determine major adverse kidney events (MAKE90). |
| Brain Natriuretic Peptide (BNP) | 24 and 48 hours time points | BNP is a hormone that is primarily secreted from the ventricular myocardium in response to hemodynamic stimuli such as ventricular volume expansion and pressure overload. The investigators will obtain levels of serum BNP at baseline, then at 24 and 48 hours. |
Countries
United States
Contacts
Primary ContactOladipupo Olafiranye, MD MS
Outcome results
None listed