IVUS Guidance to Reduce Contrast in Coronary Angioplasty (MOZART)

Minimizing cOntrast utiliZAtion With IVUS Guidance in coRonary angioplasTy: The MOZART Study

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

Study Overview

• Status: Completed
• Conditions: Acute Renal Failure; Contrast Media Reaction
• Intervention / Treatment: Device: IVUS-guided PCI

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403-000
    • Heart Institute - InCor. University of Sao Paulo Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Angiography-guided PCI; Angiography-guided percutaneous coronary intervention
Active Comparator: IVUS-guided PCI; Intravascular ultrasound guided percutaneous coronary intervention	Device: IVUS-guided PCI; Intravascular ultrasound guided percutaneous coronary intervention; Other Names: Intravascular ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Volume of Iodine Contrast Used During Procedure	Total volume of iodine contrast administered during the index procedure.	Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: InCor Heart Institute
• Investigators: Study Chair: Pedro A Lemos, MD PhD, Heart Institute - InCor. University of Sao Paulo Medical School; Principal Investigator: Paulo R Soares, MD PhD, Heart Institute - InCor. University of Sao Paulo Medical School

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: January 1, 2013
• First Submitted That Met QC Criteria: September 17, 2013
• First Posted (Estimate): September 20, 2013

Study Record Updates

• Last Update Posted (Estimate): June 15, 2016
• Last Update Submitted That Met QC Criteria: May 6, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Stent; Prevention; Percutaneous coronary intervention; Angioplasty; Coronary; Intravascular ultrasound; Contrast; Acute Renal failure
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 02358512.7.0000.0068