NCT02674451

Brief Summary

Contrast-medium induced nephropathy (CIN) is a frequent and devastating complication of coronary angiography, occurring in 10-50% of cases. As would be expected, the incidence of CIN is much higher in patients with underlying renal dysfunction. Multiple trials have found CIN to be an independent predictor of prolonged hospitalization and both 30 day and 1 year mortality in patients with coronary artery disease. Intravenous contrast dye is felt to cause renal ischemia as the mechanism of injury. Unfortunately, despite the significant morbidity and mortality with CIN, there are few therapeutic interventions to reduce the risk with the exception of hydration and high dose statin therapy. Recently, remote ischemic preconditioning (RIPC), a process of inducing transient arm ischemia by inflating a blood pressure cuff to 200 mmHg for 3 repetitive 5 minute cycles, leads to a systemic cytoprotective response and ultimately reduces ischemic renal injury, myocardial injury, and even cerebral injury following coronary bypass grafting. While there is significant data supporting the role of RIPC in reducing systemic ischemic injury in surgical patients, there is only one small trial studying RIPC in patient's undergoing coronary angiography. The investigators hypothesize that RIPC will reduce the incidence of contrast-induced nephropathy in patients with baseline renal dysfunction undergoing coronary angiography for stable or unstable coronary artery disease.

Trial Health

57
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Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2017

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

2.7 years

First QC Date

February 1, 2016

Last Update Submit

September 4, 2018

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Acute kidney injury

    Increase in serum creatinine greater than or equal to 0.05 mg/dL or a relative increase of greater than or equal to 25% of baseline.

    48 hours after contrast administration

Study Arms (2)

RIPC

ACTIVE COMPARATOR

Participants will receive remote ischemic preconditioning within one hour of coronary angiography. This involves blood pressure cuff inflation to 200mmHG for three-5 minute periods, each separated by 5 minute intervals.

Procedure: Remote ischemic preconditioning

Controls

SHAM COMPARATOR

Participants will have routine blood pressure measurements will be obtained.

Procedure: Remote ischemic preconditioning

Interventions

Remote ischemic preconditioningPROCEDURE

Blood pressure cuff inflation to 200 mmHG for three 5-minute periods each separated by 5 minute intervals within 1 hour of planned coronary angiography.

ControlsRIPC

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing coronary angiography for stable or unstable coronary artery disease
  • eGFR less than or equal to 60 mL/min/1.73 m2

You may not qualify if:

  • Subjects with known upper extremity vascular disease
  • Subjects with systolic blood pressure differential of 10 mmHg or higher in the upper extremities
  • End stage renal disease on peritoneal or hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Steven P Schulman, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 4, 2016

Study Start

August 12, 2014

Primary Completion

May 11, 2017

Study Completion

May 11, 2017

Last Updated

September 6, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)