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Minimizing Contrast Utilization With IVUS Guidance in Coronary Angioplasty to Avoid Acute Nephropathy

NCT02743156 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2016-04-26

No results posted yet for this study

Summary

Contrast-induced acute kidney injury (CI-AKI) is an important adverse effect of percutaneous coronary interventions. Despite various efforts, very few preventive measures have been shown effective in reducing its incidence.

The final volume of contrast media utilized during the procedure is a well- known independent factor affecting the occurrence of CI-AKI.

Intravascular ultrasound (IVUS) has been largely used as an adjunctive diagnostic tool during percutaneous coronary intervention (PCI). When fully explored, IVUS provides precise information for guiding PCI, thereby reducing the usage of contrast media. Accordingly, the recent MOZART study demonstrated that IVUS may lead to a 2-3-fold decrease in the volume of contrast media during PCI.

In the present study, the hypothesize that IVUS guidance, and its consequent reduction in the volume of contrast media, will in decrease the risk of CI-AKI after PCI, in comparison to standard angiography-guided intervention.

Conditions

Interventions

PROCEDURE

IVUS-guided PCI

intravascular ultrasound-guided percutaneous coronary intervention

PROCEDURE

Angiography-guided PCI

Angiography-guided percutaneous coronary intervention. This is the conventional treatment.

Sponsors & Collaborators

  • InCor Heart Institute

    lead OTHER

Principal Investigators

  • Pedro A. Lemos, MD PhD · Heart Institute - InCor. University of Sao Paulo Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-04-30
Completion
2017-05-31

Countries

  • Brazil
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT02743156 on ClinicalTrials.gov