Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography (GE OCT)

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Contrast Media Reaction
• Intervention / Treatment: Drug: Iodixanol; Drug: Iohexol

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 Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Minneapolis Heart Institute Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Iso-Osmolar Contrast Media; Will receive iso-osmolar media first, low-osmolar media second	Drug: Iodixanol; Iso-osmolar Contrast Media; Other Names: Visipaque; Drug: Iohexol; Low-Osmolar Contrast Media; Other Names: Omnipaque
ACTIVE_COMPARATOR: Low-Osmolar Contrast Media; Will receive low-osmolar media first, iso-osmolar media second	Drug: Iodixanol; Iso-osmolar Contrast Media; Other Names: Visipaque; Drug: Iohexol; Low-Osmolar Contrast Media; Other Names: Omnipaque

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast Volume after Injection	Contrast volume will be measured after each injection	30 seconds after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clear OCT Images	Length of clear OCT images will be defined as visible lumen border >270 degrees	Intra-operative
Electrocardiographic (ECG) Changes	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)	During and 30 seconds after injection

Collaborators and Investigators

• Sponsor: Minneapolis Heart Institute Foundation
• Investigators: Principal Investigator: Emmanouil Brilakis, MD, PhD, Minneapolis Heart Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2021
• Primary Completion (ANTICIPATED): March 31, 2023
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (ACTUAL): October 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography; Contrast Agents
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: GE OCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No