Overview

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

Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Minneapolis Heart Institute Foundation
Criteria
Inclusion Criteria:

1. Age 18 years or greater

2. Willing and able to give informed consent. The patients must be able to comply with
study procedures

3. Undergoing clinically-indicated coronary angiography and OCT

Exclusion Criteria

1. Baseline electrocardiographic changes hindering interpretation (such as left
bundle-branch block, and >1 mm ST segment depression)

2. Emergency cardiac catheterization (for example in patients with ST-segment elevation
acute myocardial infarction)

3. Inability to provide symptomatic assessment

4. Known allergy to contrast