drugset / Trial / NCT05065073

Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography

NCT05065073

Phase 4 Unknown 62 enrolled Minneapolis Heart Institute Foundation
RandomizedSingle-groupOpen-labelDiagnostic

Summary

The proposed study aims to compare (a) volume contrast administered for Optical Coherence Tomography (OCT) Imaging, (b) length of clear OCT images, and (c) electrocardiographic changes immediately after contrast injection between iso-osmolar and low-osmolar contrast agents. The proposed study is a prospective, single-centered, randomized controlled, study that will compare an iso-osmolar vs. a low-osmolar contrast agent in patients undergoing clinically indicated coronary OCT imaging. Each patient will be randomized to OCT acquisition.

Timeline

Start
2021-09-30
Primary completion
2023-03-31
Completion
2023-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Iodixanol Diagnostic / imaging agent
Comparator Iohexol Diagnostic / imaging agent