IVUS Guidance to Reduce Contrast in Coronary Angioplasty

Acute Renal Failure Clinical Trial

— MOZART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01947335
• Other study ID #: 02358512.7.0000.0068
• Status: Recruiting
• Phase: Phase 4
• First received: January 1, 2013
• Last updated: September 17, 2013
• Start date: November 2012
• Est. completion date: May 2014

Study information

• Verified date: September 2013
• Source: InCor Heart Institute
• Contact: Patricia Pereira
• Phone: +55 11 2661 5368
• Email: patricia.pareira[@]incor.usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Contrast-induced Acute Kidney Injury
• Renal Insufficiency

Intervention

Device:
• IVUS-guided PCI
Intravascular ultrasound guided percutaneous coronary intervention

Locations

Country	Name	City	State
Brazil	Heart Institute - InCor. University of Sao Paulo Medical School	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total volume of iodine contrast used during procedure	Total volume of iodine contrast administered during the index procedure.	Day 1	No
Secondary	Clinical and angiographic success		Day 1	No
Secondary	Major adverse cardiac events	Composite of death, myocardial infarction or repeat revascularization	30 days and 6 months	No
Secondary	Incidence of contrast-induced nephropathy	Increase >= 0.5 mg/dl in basal serum creatinine	7 days	No