Clinical trial NCT02329444: The Effect of Remote Ischemic Preconditioning on Elective Percutaneous Coronary Intervention in Diabetic Nephropathy
Official title: Remote Ischemic Preconditioning for the Prevention of Contrast-induced Acute Kidney Injury in Diabetic Patients Undergoing Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contrast Induced Acute Kidney Injury
Lead sponsor: Ulsan University Hospital
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of CI-AKI
timeFrame: 48 hours
Secondary outcomes:
measure: Relative change in NGAL levels from baseline
timeFrame: 24 hours
measure: Absolute change in NGAL levels from baseline
timeFrame: 24 hours
measure: Relative change in serum creatinine from baseline
timeFrame: 72 hours
Other outcomes:
measure: Periprocedural myocardial infarction
timeFrame: 24 hours
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Ulsan University Hospital
name: Eun-Seok Shin, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balbir Singh G, Ann SH, Park J, Chung HC, Lee JS, Kim ES, Choi JI, Lee J, Kim SJ, Shin ES. Remote Ischemic Preconditioning for the Prevention of Contrast-Induced Acute Kidney Injury in Diabetics Receiving Elective Percutaneous Coronary Intervention. PLoS One. 2016 Oct 10;11(10):e0164256. doi: 10.1371/journal.pone.0164256. eCollection 2016.