NCT02329444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

December 29, 2014

Last Update Submit

April 2, 2019

Conditions

Contrast Induced Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Relative change in NGAL levels from baseline

    24 hours

  • Absolute change in NGAL levels from baseline

    24 hours

  • Relative change in serum creatinine from baseline

    72 hours

Other Outcomes (1)

  • Periprocedural myocardial infarction

    24 hours

Study Arms (2)

Remote Ischemic Preconditioning

EXPERIMENTAL

Patients treated with Remote Ischemic Preconditioning

Procedure: Remote ischemic preconditioning

Sham ischemic preconditioning

ACTIVE COMPARATOR

Patients treated with sham ischemic preconditioning

Procedure: Sham ischemic preconditioning

Interventions

Remote ischemic preconditioningPROCEDURE

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.

Remote Ischemic Preconditioning
Sham ischemic preconditioningPROCEDURE

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.

Sham ischemic preconditioning

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulsan University Hospital

Ulsan, 682-714, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 27723839DERIVED

Study Officials

  • Eun-Seok Shin, MD., PhD.

    Ulsan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Cardiologist MD. PhD.

Study Record Dates

First Submitted

December 29, 2014

First Posted

December 31, 2014

Study Start

August 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 3, 2019

Record last verified: 2019-04

Locations

KR(1)