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NCT01989195 · ClinicalTrials.gov registry record · Phase 1
Efficacy of EVP 1001-1 (SeeMore) in the Assessment of Myocardial Viability in Patients With Cardiovascular Disease
A Phase 1 study of Ischemic Cardiomyopathy, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT01989195 is a Phase 1 study of Ischemic Cardiomyopathy that has completed, run by Stanford University. The registered enrollment target is 6 participants, below the 378-participant average among 10 other Ischemic Cardiomyopathy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01989195, a Phase 1 study of Ischemic Cardiomyopathy, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigator hopes to introduce a novel MRI contrast agent with SeeMore ™ that directly defines viable myocardium. Identifying viable myocardium non-invasively using cardiac MRI is still a moving target and a question we plan to answer more definitively with the SeeMore ™ contrast. Though well tested in small and large animals and Phase I \& II clinical trials, the investigators would like to determine the efficacy of the SeeMore contrast further in a clinical setting. SeeMore is a new manganese (Mn)-based intravenous imaging agent being developed to enhance magnetic resonance imaging (MRI). While Mn has long been known to have desirable magnetic and kinetic properties for MRI, use in humans was not initially possible due to cardiovascular depression and electrocardiogram (ECG) changes, including prolongation of PR and QTc intervals, associated with intravenous administration \[1-5\]. SeeMore provides Mn in a form that maintains the desired magnetic and kinetic properties while overcoming the cardiovascular toxicity of Mn. SeeMore is taken up into heart cells (primarily via addition of calcium to avoid cardiotoxic effects; please refer to US patent #5,980,863). The potential to distinguish healthy heart tissue from unhealthy heart tissue based on a specific sustained pattern of enhancement provides a basis for evaluating the performance of SeeMore in heart patients. It may be possible to enhance the utility of MRI for heart disease through the use of an imaging agent that is specifically taken up into heart cells. SeeMore is the only cardiac-specific agent being developed for this purpose. Unlike nuclear perfusion agents, SeeMore is not radioactive and does not require special handling, shielding, transport or storage. In addition, the specific pattern of enhancement achieved in the heart muscle persists over time, offering potential benefits over the nonspecific extracellular agents currently available for MRI or X-ray/CT procedures. This feature allows full u
Conditions Studied
Interventions
- DRUG 'SEEMORE' - MANGANESE-ENHANCED MRI CONTRAST REAGENT
Study Locations (1)
California
- Stanford University School of Medicine - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-05 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01989195
The ClinicalTrials.gov registry entry for NCT01989195 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 378-participant average among 10 other Ischemic Cardiomyopathy trials with a reported enrollment target (98% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ischemic Cardiomyopathy appearing as the primary indexed condition, and to 1 intervention - of which 'SEEMORE' - MANGANESE-ENHANCED MRI CONTRAST REAGENT is the first listed.
NCT01989195 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01989195 about?
NCT01989195 is a clinical study titled "Efficacy of EVP 1001-1 (SeeMore) in the Assessment of Myocardial Viability in Patients With Cardiovascular Disease". The investigator hopes to introduce a novel MRI contrast agent with SeeMore ™ that directly defines viable myocardium. Identifying viable myocardium non-invasively using cardiac MRI is still a moving target and a question we plan to answer more definitively with the SeeMore ™ contrast. Though well t...
What is the current status of trial NCT01989195?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2013-05. Estimated completion is 2013-06.
What conditions does trial NCT01989195 study?
This clinical trial studies the following conditions: Ischemic Cardiomyopathy.
What interventions are being tested in trial NCT01989195?
The interventions under investigation include: 'SEEMORE' - MANGANESE-ENHANCED MRI CONTRAST REAGENT (DRUG).
Who is sponsoring clinical trial NCT01989195?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01989195 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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