Phase 4 N=83 Randomized Treatment

IVUS Guidance to Reduce Contrast in Coronary Angioplasty

Contrast Media Reaction · Acute Renal Failure

Bottom Line

View on ClinicalTrials.gov: NCT01947335 ↗

Enrolled (actual)

Serious AEs

4.8%

Results posted

Jun 2016

Primary outcome: Primary: Total Volume of Iodine Contrast Used During Procedure — 64.5; 20.0 ml

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: IVUS-guided PCI (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: InCor Heart Institute
Primary completion: Sep 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Volume of Iodine Contrast Used During Procedure	64.5; 20.0	—
SECONDARY Major Adverse Cardiac Events	2; 2; 2; 5	—
SECONDARY Incidence of Contrast-induced Nephropathy	19; 7.3	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01947335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.