Minimizing Contrast Utilization With IVUS Guidance in Coronary Angioplasty to Avoid Acute Nephropathy

NCT02743156 | Unknown Phase 4

• 1 other identifier: Mozart II
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 2

Brief 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 PCI, thereby reducing the usage of contrast media. Accordingly, the recent MOZART study demonstrated that IVUS may lead to a 2-3-fold decrease in the volume of contrast media during PCI. In the present study, the hypothesize that IVUS guidance, and its consequent reduction in the volume of contrast media, will in decrease the risk of CI-AKI after PCI, in comparison to standard angiography-guided intervention.

Conditions

Acute Kidney Injury; Acute Renal Failure; Acute Renal Injury

Keywords

IVUS; Acute Renal Failure; Angioplasty; stent; contrast; percutaneous coronary intervention; intravascular ultrasound

Outcome Measures

Primary Outcomes (1)

• Contrast-induced acute kidney injury

  Evaluate whether IVUS-guided PCI reduces CI-AKI in comparison to stand-alone angiography-guided PCI. CI-AKI will be defined as an increase in serum creatinine ≥ 0.5 mg/dl from the baseline value, within 72 hours after the index procedure (or at discharge).

  72 hours

Secondary Outcomes (5)

• Major adverse cardiac events and components

  one year

• Stent thrombosis

  one year

• Serious acute kidney dysfunction

  one year

• Procedure Time

  procedure time

• Radiation exposure

  procedure time

Study Arms (2)

angiography-guided PCI

ACTIVE COMPARATOR

angiography-guided percutaneous coronary intervention

Procedure: Angiography-guided PCI

IVUS-guided PCI

EXPERIMENTAL

intravascular ultrasound guided percutaneous coronary intervention

Procedure: IVUS-guided PCI

Interventions

IVUS-guided PCI PROCEDURE

intravascular ultrasound-guided percutaneous coronary intervention

Also known as: intravascular ultrasound

IVUS-guided PCI

Angiography-guided PCI PROCEDURE

Angiography-guided percutaneous coronary intervention. This is the conventional treatment.

angiography-guided PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Coronary artery disease referred for percutaneous intervention, with stent implantation, of one or more epicardial vessel.
• \>All target lesions must be amenable to IVUS imaging, as judged by an experienced interventionalist (lesions not assessable by IVUS at baseline but which are judged to the assessable at any time during the procedure are eligible).
• Baseline calculated creatinine clearance \< 60 ml/min/1.73 m2 or baseline creatinine \> 1.5 mg/dl
• Ability to sign informed consent and comply with all study procedures

You may not qualify if:

• Use of \> 50 ml (single-lesion PCI) or \> 70 ml (multi-lesion PCI) of iodinated agents \< 72 hours (this restriction includes the contrast used during the diagnostic phase of ad hoc PCI).
• Planned use of iodinated contrast within the next 72 hours after the index procedure
• Use of other nephrotoxic agents \< 7 days
• Known allergy to contrast agents
• Unstable or unknown renal function prior to PCI.
• Prior PCI of the target lesions
• Patients requiring additional surgery (cardiac or non cardiac) within 72 hours after the index procedure
• Non cardiac co-morbidities with life expectancy less than 1 year
• Other investigational drug or device studies that have not reached their primary endpoint

Sponsors & Collaborators

• InCor Heart Institute: lead

Study Sites (2)

Heart Institute - InCor. University of Sao Paulo Medical School

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Hospital Clinic

Barcelona, Catalonia, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Ultrasonography, Interventional

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Pedro A. Lemos, MD PhD

  Heart Institute - InCor. University of Sao Paulo Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Pereira

CONTACT

+551126615368; patricia@incor.usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 10, 2016
• First Posted: April 19, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: April 26, 2016

Record last verified: 2016-04

Locations

BR (1); ES (1)