The Effect of Remote Ischemic Preconditioning on Elective Percutaneous Coronary Intervention in Diabetic Nephropathy

Ulsan University Hospital

Status: Completed

Conditions: Contrast Induced Acute Kidney Injury

Treatments: Procedure: Remote ischemic preconditioning; Procedure: Sham ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02329444

2011-08-074

Details and patient eligibility

About

Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. When remote ischemic preconditioning is applied before percutaneous coronary intervention (PCI), the kidneys can be protected against ischemia-reperfusion injury and subsequently CI-AKI. In this randomised controlled trial, diabetic nephropathy patients undergoing PCI as part of their assessment and treatment of cardiovascular disease are randomized to receive RIPC or control sham preconditioning.

Full description

Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. Diabetes with pre-existing renal disease can increase the risk of CI-AKI. Remote ischemic preconditioning (RIPC) is a non-pharmacological strategy inducing transient episodes of ischemia by the occlusion of blood flow in non-target tissue such as a limb, before a subsequent prolonged ischemia-reperfusion injury occurs in a more distant organ. These brief, repeated ischemic episodes in the limb can confer a protection at more remote sites such as the heart, brain, lung, kidney, intestine or skeletal muscle. In a recent pilot study, using RIPC prior to coronary angiography in high risk patients with moderate chronic kidney disease, the authors found that RIPC significantly reduced the incidence of CI-AKI (Er et al Circulation. 2012;126(3),296). We hypothesized that RIPC would be protective as an adjunctive therapy in reducing the incidence of CI-AKI in diabetics with pre-existing CKD. This prospective study was performed to evaluate the efficacy of RIPC for the prevention of CI-AKI among diabetic nephropathy patients undergoing percutaneous coronary intervention.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed written consent
• All of the following:
• Known diagnosis of Type 2 diabetes
• NSTEMI, unstable or stable angina
• Patients undergoing elective coronary angiography and/or percutaneous coronary intervention
• eGFR < 60 mls/min or ACR > 300 mg/dl

Exclusion criteria

• STEMI
• decompensated heart failure in the preceding 6 months
• patients with underlying end stage renal disease on maintenance dialysis
• recent (in the last 3 months) cerebrovascular disease
• chronic liver disease
• chronic obstructive pulmonary disease
• gastrointestinal bleeding
• acute or chronic infection or malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Remote Ischemic Preconditioning

Experimental group

Description:

Patients treated with Remote Ischemic Preconditioning

Treatment:

Procedure: Remote ischemic preconditioning

Sham ischemic preconditioning

Active Comparator group

Description:

Patients treated with sham ischemic preconditioning

Treatment:

Procedure: Sham ischemic preconditioning