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

Remote Ischemic Preconditioning for the Prevention of Contrast-induced Acute Kidney Injury in Diabetic Patients Undergoing Percutaneous Coronary Intervention

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.

Study Overview

• Status: Completed
• Conditions: Contrast Induced Acute Kidney Injury
• Intervention / Treatment: Procedure: Remote ischemic preconditioning; Procedure: Sham ischemic 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ulsan, Korea, Republic of, 682-714
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote Ischemic Preconditioning; Patients treated with Remote Ischemic Preconditioning	Procedure: Remote ischemic preconditioning; Appropriately sized sphygmomanometer cuff placed around right upper arm; where contraindicated, left arm, with inflation of the cuff up to 200mmHg for 5 minutes, followed by deflation of 5 minutes to allow reperfusion with cycle repeated 3 times.
Active Comparator: Sham ischemic preconditioning; Patients treated with sham ischemic preconditioning	Procedure: Sham ischemic preconditioning; Appropriately sized sphygmomanometer cuff placed around right upper arm; where contraindicated, left arm, with inflation of the cuff up to 50mmHg for 5 minutes, followed by deflation of 5 minutes to allow reperfusion with cycle repeated 3 times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of CI-AKI	defined as a creatinine rise of ≥ 25% or an increase of > 0.5mg/dl from baseline within 48 hours after contrast exposure	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in NGAL levels from baseline	Defined as a change in serum NGAL value from baseline	24 hours
Absolute change in NGAL levels from baseline	Defined as a change in serum NGAL value from baseline	24 hours
Relative change in serum creatinine from baseline	Defined as a change in serum value from baseline	72 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periprocedural myocardial infarction	Defined as Trop T or CKMB levels >3 times the upper limit of normal	24 hours

Collaborators and Investigators

• Sponsor: Ulsan University Hospital
• Investigators: Principal Investigator: Eun-Seok Shin, MD., PhD., Ulsan University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: December 29, 2014
• First Submitted That Met QC Criteria: December 29, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 2011-08-074