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IVUS Guidance to Reduce Contrast in Coronary Angioplasty (MOZART)

Primary Purpose

Contrast Media Reaction, Acute Renal Failure

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
IVUS-guided PCI
Sponsored by
InCor Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contrast Media Reaction focused on measuring Coronary, Angioplasty, Percutaneous coronary intervention, Stent, Contrast, Acute Renal failure, Intravascular ultrasound, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Heart Institute - InCor. University of Sao Paulo Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Angiography-guided PCI

IVUS-guided PCI

Arm Description

Angiography-guided percutaneous coronary intervention

Intravascular ultrasound guided percutaneous coronary intervention

Outcomes

Primary Outcome Measures

Total Volume of Iodine Contrast Used During Procedure
Total volume of iodine contrast administered during the index procedure.

Secondary Outcome Measures

Major Adverse Cardiac Events
Composite of death, myocardial infarction or repeat revascularization
Incidence of Contrast-induced Nephropathy
Increase >= 0.5 mg/dl in basal serum creatinine

Full Information

First Posted
January 1, 2013
Last Updated
May 6, 2016
Sponsor
InCor Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01947335
Brief Title
IVUS Guidance to Reduce Contrast in Coronary Angioplasty
Acronym
MOZART
Official Title
Minimizing cOntrast utiliZAtion With IVUS Guidance in coRonary angioplasTy: The MOZART Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
InCor Heart Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Media Reaction, Acute Renal Failure
Keywords
Coronary, Angioplasty, Percutaneous coronary intervention, Stent, Contrast, Acute Renal failure, Intravascular ultrasound, Prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Angiography-guided PCI
Arm Type
No Intervention
Arm Description
Angiography-guided percutaneous coronary intervention
Arm Title
IVUS-guided PCI
Arm Type
Active Comparator
Arm Description
Intravascular ultrasound guided percutaneous coronary intervention
Intervention Type
Device
Intervention Name(s)
IVUS-guided PCI
Other Intervention Name(s)
Intravascular ultrasound
Intervention Description
Intravascular ultrasound guided percutaneous coronary intervention
Primary Outcome Measure Information:
Title
Total Volume of Iodine Contrast Used During Procedure
Description
Total volume of iodine contrast administered during the index procedure.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Major Adverse Cardiac Events
Description
Composite of death, myocardial infarction or repeat revascularization
Time Frame
30 days and 6 months
Title
Incidence of Contrast-induced Nephropathy
Description
Increase >= 0.5 mg/dl in basal serum creatinine
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro A Lemos, MD PhD
Organizational Affiliation
Heart Institute - InCor. University of Sao Paulo Medical School
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paulo R Soares, MD PhD
Organizational Affiliation
Heart Institute - InCor. University of Sao Paulo Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute - InCor. University of Sao Paulo Medical School
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25326742
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.
Results Reference
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IVUS Guidance to Reduce Contrast in Coronary Angioplasty

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