Coronary Artery DiseasePhase 4GE OCTNCT05065073
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
A Phase 4 study testing Iodixanol and Iohexol in people with Coronary Artery Disease and Contrast Media Reaction, run by Minneapolis Heart Institute Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Contrast Media Reaction
- What is being tested?
- Iodixanol and Iohexol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2021to 30 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
About this study
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.
Read the 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
- Conditions
- Coronary Artery Disease, Contrast Media Reaction
- Being tested
- Iodixanol, Iohexol
- Keywords
- Optical Coherence Tomography, Contrast Agents
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IodixanolDrug
Also called Visipaque
Iso-osmolar Contrast Media
IohexolDrug
Also called Omnipaque
Low-Osmolar Contrast Media
| Study group | Role | What they receive |
|---|---|---|
| Iso-Osmolar Contrast Media | Active comparator | Will receive iso-osmolar media first, low-osmolar media second Receives: Drug: Iodixanol; Drug: Iohexol |
| Low-Osmolar Contrast Media | Active comparator | Will receive low-osmolar media first, iso-osmolar media second Receives: Drug: Iodixanol; Drug: Iohexol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast Volume after Injection
Contrast volume will be measured after each injection
Measured: 30 seconds after injection
Secondary outcomes (2)
Clear OCT Images
Length of clear OCT images will be defined as visible lumen border >270 degrees
Measured: 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)
Measured: During and 30 seconds after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start30 Sep 2021
- Primary completion31 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- 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 other
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanouil Brilakis, MD, PhD, Principal investigator, Minneapolis Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065073
- Sponsor's protocol ID
- GE OCT
- Acronym
- GE OCT
- Status last verified
- Oct 2021
- First submitted
- 14 Sep 2021
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT05065073
- Acronym / sponsor ID
- GE OCT / GE OCT
- Conditions
- Coronary Artery Disease, Contrast Media Reaction
- Keywords
- Optical Coherence Tomography, Contrast Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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 other
| Arm | Type | Receives |
|---|---|---|
| Iso-Osmolar Contrast Media | Active comparator | Drug: Iodixanol, Drug: IohexolWill receive iso-osmolar media first, low-osmolar media second |
| Low-Osmolar Contrast Media | Active comparator | Drug: Iodixanol, Drug: IohexolWill receive low-osmolar media first, iso-osmolar media second |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IodixanolAlso: VisipaqueIso-osmolar Contrast Media | Drug | Iso-Osmolar Contrast Media, Low-Osmolar Contrast Media |
| IohexolAlso: OmnipaqueLow-Osmolar Contrast Media | Drug | Iso-Osmolar Contrast Media, Low-Osmolar Contrast Media |
Primary outcome
Contrast Volume after Injection
Time frame: 30 seconds after injection
Contrast volume will be measured after each injection
2 secondary outcomes
Clear OCT Images
Time frame: Intra-operative
Electrocardiographic (ECG) Changes
Time frame: During and 30 seconds after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanouil Brilakis, MD, PhD principal investigator
Minneapolis Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iodixanol and Iohexol in people with Coronary Artery Disease and Contrast Media Reaction, run by Minneapolis Heart Institute Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast Volume after Injection (time frame: 30 seconds after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.