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

NCT05065073 | Unknown Phase 4 FDA Drug

• 1 other identifier: GE OCT
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Contrast Media Reaction

Keywords

Optical Coherence Tomography; Contrast Agents

Outcome Measures

Primary Outcomes (1)

• Contrast Volume after Injection

  Contrast volume will be measured after each injection

  30 seconds after injection

Secondary Outcomes (2)

• Clear OCT Images

  Intra-operative

• Electrocardiographic (ECG) Changes

  During and 30 seconds after injection

Study Arms (2)

Iso-Osmolar Contrast Media

ACTIVE COMPARATOR

Will receive iso-osmolar media first, low-osmolar media second

Drug: Iodixanol; Drug: Iohexol

Low-Osmolar Contrast Media

ACTIVE COMPARATOR

Will receive low-osmolar media first, iso-osmolar media second

Drug: Iodixanol; Drug: Iohexol

Interventions

Iodixanol DRUG

Iso-osmolar Contrast Media

Also known as: Visipaque

Iso-Osmolar Contrast Media; Low-Osmolar Contrast Media

Iohexol DRUG

Low-Osmolar Contrast Media

Also known as: Omnipaque

Iso-Osmolar Contrast Media; Low-Osmolar Contrast Media

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or greater
• Willing and able to give informed consent. The patients must be able to comply with study procedures
• Undergoing clinically-indicated coronary angiography and OCT

You may not qualify if:

• Baseline electrocardiographic changes hindering interpretation (such as left bundle-branch block, and \>1 mm ST segment depression)
• Emergency cardiac catheterization (for example in patients with ST-segment elevation acute myocardial infarction)
• Inability to provide symptomatic assessment
• Known allergy to contrast

Sponsors & Collaborators

• Minneapolis Heart Institute Foundation: lead

Study Sites (1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

iodixanol; Iohexol

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Emmanouil Brilakis, MD, PhD

  Minneapolis Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bavana Rangan, BDS, MPH

CONTACT

817-821-9945; bavana.rangan@allina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 other

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 1, 2021
• Study Start: September 30, 2021
• Primary Completion: March 31, 2023
• Study Completion: June 30, 2023
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)