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This study tests the hypothesis that ultrasound-guided PCI reduces contrast volume during the procedure.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angiography-guided PCI | No Intervention | Angiography-guided percutaneous coronary intervention | |
| IVUS-guided PCI | Active Comparator | Intravascular ultrasound guided percutaneous coronary intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVUS-guided PCI | Device | Intravascular ultrasound guided percutaneous coronary intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Volume of Iodine Contrast Used During Procedure | Total volume of iodine contrast administered during the index procedure. | Day 1 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro A Lemos, MD PhD | Heart Institute - InCor. University of Sao Paulo Medical School | Study Chair |
| Paulo R Soares, 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 | São Paulo | São Paulo | 05403-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25326742 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Angiography-guided PCI | Angiography-guided percutaneous coronary intervention |
| FG001 | IVUS-guided PCI | Intravascular ultrasound guided percutaneous coronary intervention IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Angiography-guided PCI | Angiography-guided percutaneous coronary intervention |
| BG001 | IVUS-guided PCI | Intravascular ultrasound guided percutaneous coronary intervention IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Volume of Iodine Contrast Used During Procedure | Total volume of iodine contrast administered during the index procedure. | Posted | Median | Inter-Quartile Range | ml | Day 1 |
|
In-hospital
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Angiography-guided PCI | Angiography-guided percutaneous coronary intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Periprocedural Infarction | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peak increase in creatinine > 0.5mg/dl | Renal and urinary disorders | Systematic Assessment | Peak increase in creatinine > 0.5mg/dl |
Patients were enrolled according to somewhat restricted criteria, which excluded patients with recent catheterization, using nephrotoxic agents, or with unstable or unknown renal function.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pedro A. Lemos | Heart Institute (Incor) | +55 11 2661 5000 | pedro.lemos@incor.usp.br |
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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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| 7 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Major Adverse Cardiac Events | Composite of death, myocardial infarction or repeat revascularization | Posted | Number | participants | 30 days and 6 months |
|
|
|
| Secondary | Incidence of Contrast-induced Nephropathy | Increase >= 0.5 mg/dl in basal serum creatinine | Posted | Number | percentage of participants | 7 days |
|
|
|
| 2 |
| 42 |
| 8 |
| 42 |
| EG001 | IVUS-guided PCI | Intravascular ultrasound guided percutaneous coronary intervention IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention | 2 | 41 | 3 | 41 |
| Unplanned revascularization | Cardiac disorders | Systematic Assessment |
|
| Stent Thrombosis | Cardiac disorders | Systematic Assessment |
|
| Death | Cardiac disorders | Systematic Assessment |
|
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D019060 |
| Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |