Clinical trial NCT01947335: IVUS Guidance to Reduce Contrast in Coronary Angioplasty
Official title: Minimizing cOntrast utiliZAtion With IVUS Guidance in coRonary angioplasTy: The MOZART Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contrast Media Reaction
Acute Renal Failure
Keywords: Coronary
Angioplasty
Percutaneous coronary intervention
Stent
Contrast
Acute Renal failure
Intravascular ultrasound
Prevention
Lead sponsor: InCor Heart Institute
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Volume of Iodine Contrast Used During Procedure
timeFrame: Day 1
Secondary outcomes:
measure: Major Adverse Cardiac Events
timeFrame: 30 days and 6 months
measure: Incidence of Contrast-induced Nephropathy
timeFrame: 7 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute - InCor. University of Sao Paulo Medical School
Study officials:
affiliation: Heart Institute - InCor. University of Sao Paulo Medical School
name: Pedro A Lemos, MD PhD
role: STUDY_CHAIR
affiliation: Heart Institute - InCor. University of Sao Paulo Medical School
name: Paulo R Soares, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mariani J Jr, Guedes C, Soares P, Zalc S, Campos CM, Lopes AC, Spadaro AG, Perin MA, Filho AE, Takimura CK, Ribeiro E, Kalil-Filho R, Edelman ER, Serruys PW, Lemos PA. Intravascular ultrasound guidance to minimize the use of iodine contrast in percutaneous coronary intervention: the MOZART (Minimizing cOntrast utiliZation With IVUS Guidance in coRonary angioplasTy) randomized controlled trial. JACC Cardiovasc Interv. 2014 Nov;7(11):1287-93. doi: 10.1016/j.jcin.2014.05.024. Epub 2014 Oct 15.