IVUS Guidance to Reduce Contrast in Coronary Angioplasty

Phase 4

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
IVUS-guided PCI	IVUS-guided PCI	Intravascular ultrasound guided percutaneous coronary intervention

Primary Outcome Measures

Name	Time	Method
Total Volume of Iodine Contrast Used During Procedure	Day 1	Total volume of iodine contrast administered during the index procedure.

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events	30 days and 6 months	Composite of death, myocardial infarction or repeat revascularization
Incidence of Contrast-induced Nephropathy	7 days	Increase \>= 0.5 mg/dl in basal serum creatinine