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Remote Ischemic Preconditioning to Prevent Contrast Nephropathy

NCT02674451 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-09-06

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Remote ischemic preconditioning

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.

Sponsors & Collaborators

Principal Investigators

  • Steven P Schulman, M.D. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-12
Primary Completion
2017-05-11
Completion
2017-05-11

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02674451 on ClinicalTrials.gov