IVUS Guidance to Reduce Contrast in Coronary Angioplasty

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

Detailed Description
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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.

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

Conditions
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Contrast Media Reaction, Acute Renal Failure

Intervention / Treatment
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* Device: IVUS-guided PCI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Angiography-guided PCI<br>Angiography-guided percutaneous coronary intervention | |
| Active Comparator: IVUS-guided PCI<br>Intravascular ultrasound guided percutaneous coronary intervention | Device: IVUS-guided PCI<br>* Intravascular ultrasound guided percutaneous coronary intervention<br>* Other names: Intravascular ultrasound;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stent, Coronary, Angioplasty, Percutaneous coronary intervention, Contrast, Acute Renal failure, Intravascular ultrasound, Prevention