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

NCT05065073 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2021-10-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Iodixanol

Iso-osmolar Contrast Media

DRUG

Iohexol

Low-Osmolar Contrast Media

Sponsors & Collaborators

  • Minneapolis Heart Institute Foundation

    lead OTHER

Principal Investigators

  • Emmanouil Brilakis, MD, PhD · Minneapolis Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2023-03-31
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05065073 on ClinicalTrials.gov