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

Phase 4

• Conditions: Contrast Media Reaction; Coronary Artery Disease
• Interventions: Drug: Iodixanol; Drug: Iohexol

• Registration Number: NCT05065073
• Lead Sponsor: Minneapolis Heart Institute Foundation

Brief 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.

Detailed Description

Patients referred to the Cardiac Catheterization laboratory for clinically indicated coronary angiography and coronary OCT imaging will be identified by a study team member and screened for eligibility. The proposed study is a prospective, single-center, 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. Eligible patients will be approached to obtain informed consent by a member of the study team. Once consent is obtained and inclusion and exclusion criteria are verified, patients are randomized to undergoing OCT image acquisition with iso-osmolar contrast media(IOCM) first or with low-osmolar contrast media first (LOCM).

Then the patients undergo coronary angiography and OCT imaging as per clinical standard of care. However, during the OCT imaging acquisition based on their randomization assignment the patient will undergo the 1st OCT imaging run with either iso-osmolar contrast media or with low-osmolar contrast media. Following this a 2nd OCT imaging run of the same coronary vessel will be done using the other contrast media that was not used during the first run. Therefore, each patient will serve as a comparator to themselves, but also to each other. The electrocardiogram will be recorded during and for 30 seconds after each injection and analyzed offline for detection of any changes

Study Timeline

• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-23
• Study Start: 2021-09-30
• Status Verified: 2021-10
• Study First Posted: 2021-10-01
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-25
• Primary Completion: 2023-03-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iso-Osmolar Contrast Media	Iodixanol	Will receive iso-osmolar media first, low-osmolar media second
Iso-Osmolar Contrast Media	Iohexol	Will receive iso-osmolar media first, low-osmolar media second
Low-Osmolar Contrast Media	Iodixanol	Will receive low-osmolar media first, iso-osmolar media second
Low-Osmolar Contrast Media	Iohexol	Will receive low-osmolar media first, iso-osmolar media second

Primary Outcome Measures

Name	Time	Method
Contrast Volume after Injection	30 seconds after injection	Contrast volume will be measured after each injection

Secondary Outcome Measures

Name	Time	Method
Clear OCT Images	Intra-operative	Length of clear OCT images will be defined as visible lumen border \>270 degrees
Electrocardiographic (ECG) Changes	During and 30 seconds after injection	Electrocardiographic(ECG) changes will be assessed during and for a period of 30 seconds after each injection of contrast for OCT, to detect and quantify any of the following abnormalities: arrhythmias, mean axis deviation and QRS enlargement (type A abnormalities); and ventricular repolarization (ST/T) changes (type B abnormalities)

Trial Locations

Locations (1)

Minneapolis Heart Institute Foundation; 🇺🇸 Minneapolis, Minnesota, United States