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

• Sponsor: Minneapolis Heart Institute Foundation (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05065073
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Contrast Media Reaction	Drug: Iodixanol; Drug: Iohexol	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Randomized, controlled study. Each patient will be randomized to undergoing OCT image acquisition with iso-osmolar contrast media first, or with low-osmolar contrast media first. Following this will be a second OCT image acquisition of the same coronary vessel with the other contrast media. Thus, each patient will serve as comparator to themselves, and to each otherRandomized, controlled study. Each patient will be randomized to undergoing OCT image acquisition with iso-osmolar contrast media first, or with low-osmolar contrast media first. Following this will be a second OCT image acquisition of the same coronary vessel with the other contrast media. Thus, each patient will serve as comparator to themselves, and to each other
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
• Actual Study Start Date: Sep 30, 2021
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Contrast Volume after Injection [30 seconds after injection]

   Contrast volume will be measured after each injection

Secondary Outcome Measures

1. Clear OCT Images [Intra-operative]

   Length of clear OCT images will be defined as visible lumen border >270 degrees

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	United States	55407

Sponsors and Collaborators

• Minneapolis Heart Institute Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Minneapolis Heart Institute Foundation
• ClinicalTrials.gov Identifier: NCT05065073
• Other Study ID Numbers: GE OCT
• First Posted: Oct 1, 2021
• Last Update Posted: Oct 25, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Minneapolis Heart Institute Foundation: Optical Coherence Tomography; Contrast Agents
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

No Results Posted as of Oct 25, 2021