IVUS Guidance to Reduce Contrast in Coronary Angioplasty (MOZART)

University of São Paulo (USP)

Status and phase

Completed

Phase 4

Conditions

Contrast Media Reaction

Acute Renal Failure

Treatments

Device: IVUS-guided PCI

Study type

Interventional

Funder types

Other

Identifiers

NCT01947335

02358512.7.0000.0068

Details and patient eligibility

About

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

Full 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.

Enrollment

83 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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