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Completed

NCT Number: NCT01947335

IVUS Guidance to Reduce Contrast in Coronary Angioplasty

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Heart Institute - InCor. University of Sao Paulo Medical School

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IVUS-guided PCI

Device

Intravascular ultrasound guided percutaneous coronary intervention

Other names: Intravascular ultrasound

Primary outcomes

  1. Total Volume of Iodine Contrast Used During Procedure

    Time frame: Day 1

    Total volume of iodine contrast administered during the index procedure.

Secondary outcomes

  1. Major Adverse Cardiac Events

    Time frame: 30 days and 6 months

    Composite of death, myocardial infarction or repeat revascularization

  2. Incidence of Contrast-induced Nephropathy

    Time frame: 7 days

    Increase >= 0.5 mg/dl in basal serum creatinine

Sponsors and collaborators

Lead sponsor

InCor Heart Institute

Other

Registry information

Official study title

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

Acronym: MOZART

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 20, 2013
Registry last updated
Jun 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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