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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| angiography-guided PCI | Active Comparator | angiography-guided percutaneous coronary intervention |
|
| IVUS-guided PCI | Experimental | intravascular ultrasound guided percutaneous coronary intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVUS-guided PCI | Procedure | intravascular ultrasound-guided percutaneous coronary intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events and components | cardiovascular death, myocardial infarction and target vessel revascularization | one year |
| Stent thrombosis | stent thrombosis will be defined as the occurrence of definite or probable stent thrombosis according to the Academic Research Consortium (ARC) criteria |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Pereira | Contact | +551126615368 | patricia@incor.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Pedro A. Lemos, MD PhD | Heart Institute - InCor. University of Sao Paulo Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute - InCor. University of Sao Paulo Medical School | Recruiting | São Paulo | São Paulo | 05403-000 | Brazil |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D018084 | Ultrasonography, Interventional |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Angiography-guided PCI | Procedure | Angiography-guided percutaneous coronary intervention. This is the conventional treatment. |
|
| one year |
| Serious acute kidney dysfunction | increase in serum creatinine ≥ 2 mg/dl or need for dialysis | one year |
| Procedure Time | procedure time |
| Radiation exposure | procedure time |
| Hospital Clinic | Recruiting | Barcelona | Catalonia | 08036 | Spain |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D019060 |
| Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |