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Contrast Agent
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography (GE OCT Trial)
Phase 4
Waitlist Available
Led By Emmanouil Brilakis, MD, PhD
Research Sponsored by Minneapolis Heart Institute Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during and 30 seconds after injection
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Approved for 5 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved
Summary
This trial will compare the effects of two different types of contrast agents on OCT images and heart function.
Eligible Conditions
- Coronary Artery Disease
- Contrast Media Reaction
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 seconds after injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 seconds after injection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Contrast Volume after Injection
Secondary study objectives
Clear OCT Images
Electrocardiographic (ECG) Changes
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Active Control
Group I: Iso-Osmolar Contrast MediaActive Control2 Interventions
Will receive iso-osmolar media first, low-osmolar media second
Group II: Low-Osmolar Contrast MediaActive Control2 Interventions
Will receive low-osmolar media first, iso-osmolar media second
Find a Location
Who is running the clinical trial?
Minneapolis Heart Institute FoundationLead Sponsor
30 Previous Clinical Trials
15,598 Total Patients Enrolled
7 Trials studying Coronary Artery Disease
10,341 Patients Enrolled for Coronary Artery Disease
Emmanouil Brilakis, MD, PhDPrincipal InvestigatorMinneapolis Heart Institute
2 Previous Clinical Trials
3,296 Total Patients Enrolled