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

NCT ID: NCT05065073

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2023-06-30

Brief Summary

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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

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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

Conditions

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Coronary Artery Disease Contrast Media Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Iso-Osmolar Contrast Media

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

Group Type ACTIVE_COMPARATOR

Iodixanol

Intervention Type DRUG

Iso-osmolar Contrast Media

Iohexol

Intervention Type DRUG

Low-Osmolar Contrast Media

Low-Osmolar Contrast Media

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

Group Type ACTIVE_COMPARATOR

Iodixanol

Intervention Type DRUG

Iso-osmolar Contrast Media

Iohexol

Intervention Type DRUG

Low-Osmolar Contrast Media

Interventions

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Iodixanol

Iso-osmolar Contrast Media

Intervention Type DRUG

Iohexol

Low-Osmolar Contrast Media

Intervention Type DRUG

Other Intervention Names

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Visipaque Omnipaque

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minneapolis Heart Institute Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanouil Brilakis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Heart Institute

Locations

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Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bavana Rangan, BDS, MPH

Role: CONTACT

[email protected]
817-821-9945

Facility Contacts

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Bavana V Rangan, BDS, MPH

Role: primary

[email protected]
817-821-9945

Other Identifiers

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GE OCT

Identifier Type: -

Identifier Source: org_study_id