Contrast Media Reaction, Acute Renal Failure
Conditions
Keywords
Coronary, Angioplasty, Percutaneous coronary intervention, Stent, Contrast, Acute Renal failure, Intravascular ultrasound, Prevention
Brief summary
This study tests the hypothesis that ultrasound-guided PCI reduces contrast volume during the procedure.
Detailed description
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.
Interventions
DEVICEIVUS-guided PCI
Intravascular ultrasound guided percutaneous coronary intervention
Sponsors
InCor Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Volume of Iodine Contrast Used During Procedure | Day 1 | Total volume of iodine contrast administered during the index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events | 30 days and 6 months | Composite of death, myocardial infarction or repeat revascularization |
| Incidence of Contrast-induced Nephropathy | 7 days | Increase \>= 0.5 mg/dl in basal serum creatinine |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Angiography-guided PCI Angiography-guided percutaneous coronary intervention | 42 |
| IVUS-guided PCI Intravascular ultrasound guided percutaneous coronary intervention
IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention | 41 |
| Total | 83 |
Baseline characteristics
| Characteristic | Angiography-guided PCI | IVUS-guided PCI | Total |
|---|---|---|---|
| Age, Continuous | 62.1 years | 67.1 years | 64.6 years |
| Region of Enrollment Brazil | 42 participants | 41 participants | 83 participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 24 Participants | 24 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 42 | 3 / 41 |
| serious Total, serious adverse events | 2 / 42 | 2 / 41 |
Outcome results
Primary
Total Volume of Iodine Contrast Used During Procedure
Total volume of iodine contrast administered during the index procedure.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Angiography-guided PCI | Total Volume of Iodine Contrast Used During Procedure | 64.5 ml |
| IVUS-guided PCI | Total Volume of Iodine Contrast Used During Procedure | 20.0 ml |
Secondary
Incidence of Contrast-induced Nephropathy
Increase \>= 0.5 mg/dl in basal serum creatinine
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Angiography-guided PCI | Incidence of Contrast-induced Nephropathy | 19 percentage of participants |
| IVUS-guided PCI | Incidence of Contrast-induced Nephropathy | 7.3 percentage of participants |
Secondary
Major Adverse Cardiac Events
Composite of death, myocardial infarction or repeat revascularization
Time frame: 30 days and 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Angiography-guided PCI | Major Adverse Cardiac Events | 30 days | 2 participants |
| Angiography-guided PCI | Major Adverse Cardiac Events | 6-months | 2 participants |
| IVUS-guided PCI | Major Adverse Cardiac Events | 30 days | 2 participants |
| IVUS-guided PCI | Major Adverse Cardiac Events | 6-months | 5 participants |