IVUS Guidance to Reduce Contrast in Coronary Angioplasty

Phase 4CompletedNCT01947335

InCor Heart Institute83 enrolled

Overview

This study tests the hypothesis that ultrasound-guided PCI reduces contrast volume during the procedure.

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 the PCI strategy. IVUS allows accurate vessel and lesion sizing, determination of plaque calcification (and the need for pre-stent plaque preparation), assessment of post-stent results (including edge dissections and residual lesion, as well as stent underexpansion or incomplete apposition). Therefore, IVUS has the potential to reduce the utilization of contrast media during PCI. In the present study, we hypothesize that IVUS guidance is associated with a significant reduction in the volume of contrast media during PCI, in comparison to standard angiography-guided intervention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Contrast Media Reaction Acute Renal Failure

Interventions

IVUS-guided PCIDEVICE

Intravascular ultrasound guided percutaneous coronary intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent * Age \>=18 years * Coronary artery disease scheduled for percutaneous intervention * Technical feasibility for intravascular ultrasound to guide coronary angioplasty * Increased risk for contrast-induced acute renal failure (e.g. age \> 80 years, female gender, diabetes, urgent or emergent procedure priority, diabetes, congestive heart failure, increased baseline serum creatinine, decreased calculated or measured creatinine clearance, intra-aortic balloon pumping, previous renal transplantation or single kidney) Exclusion Criteria: * Anticipated technical impossibility for intravascular ultrasound * Unknown baseline renal function * Baseline end-stage renal failure needing dialysis * Acute renal failure with dynamic change in renal function at the time of index procedure * Iodine contrast administration \<= 72 prior to index procedure * Known allergy to iodine contrast

Locations (1)

Heart Institute - InCor. University of Sao Paulo Medical School

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Total Volume of Iodine Contrast Used During Procedure

Total volume of iodine contrast administered during the index procedure.

Time frame: Day 1

Secondary Outcomes

Major Adverse Cardiac Events

Composite of death, myocardial infarction or repeat revascularization

Time frame: 30 days and 6 months

Incidence of Contrast-induced Nephropathy

Increase \>= 0.5 mg/dl in basal serum creatinine

Time frame: 7 days

Data from ClinicalTrials.gov

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