Acute Myocardial InfarctionPhase 2/3NCT00886444
Comparative Evaluation of Various Combinable Magnetic Resonance (CMR) Pulse-sequences for Macrophage Imaging Using Ferucarbotran
A Phase 2/3 study testing Ferucarbotran (Resovist) in people with Acute Myocardial Infarction, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 1 site in Germany.
Trial summary
The aim of this study is to: clarify whether macrophage imaging using ferucarbotran is able to delineate the region of myocardial infarction as accurate as gadolinium-based necrosis/fibrosis imaging; identify possible differences in infarct imaging using ferucarbotran for macrophage imaging compared to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Ferucarbotran (Resovist)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2009to Mar 2010
- Phase
- Phase 2/3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute myocardial infarction (STEMI or NSTEMI)
Who cannot join
- contraindication to CMR or Magnevist® or Resovist®
Trial locations and contacts
1 site in 1 country.
Germany1 site
Robert-Bosch-Krankenhaus, Division of Cardiology
Stuttgart, 70376
About this study
Official title: Comparative Evaluation of Various CMR Pulse-Sequences for Macrophage Imaging Using Ferucarbotran as Molecular Contrast Agent in Human Myocardial Infarction
The aim of this study is to:
- clarify whether macrophage imaging using ferucarbotran is able to delineate the region of myocardial infarction as accurate as gadolinium-based necrosis/fibrosis imaging;
- identify possible differences in infarct imaging using ferucarbotran for macrophage imaging compared to necrosis/fibrosis imaging with gadolinium-based compounds; and
- evaluate which MRI pulse-sequences maximise sensitivity for macrophage imaging with ferucarbotran in the setting of acute myocardial infarction.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Ferucarbotran (Resovist)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferucarbotran (Resovist)Drug
Also called Resovist
single time intravenous bolus injection of a contrast agent
| Study group | Role | What they receive |
|---|---|---|
| Ferucarbotran | Experimental | Not described Receives: Drug: Ferucarbotran (Resovist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of myocardial infarction (as demonstrated with gadolinium-based necrosis/ fibrosis imaging compared to macrophage imaging using ferucarbotran)
Measured: within 5 - 15 days after myocardial infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Udo Sechtem, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Investigators
- Udo Sechtem, MD, Study director, Robert Bosch Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886444
- Sponsor's protocol ID
- NIMINI-1
- Other IDs
- RBK-143
- Status last verified
- Nov 2014
- First submitted
- 20 Apr 2009
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Various CMR Pulse-Sequences for Macrophage Imaging Using Ferucarbotran as Molecular Contrast Agent in Human Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00886444
- Acronym / sponsor ID
- NIMINI-1
- Conditions
- Acute Myocardial Infarction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)University, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- First posted
- 23 Apr 2009 (estimated)
- 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 aim of this study is to:
- clarify whether macrophage imaging using ferucarbotran is able to delineate the region of myocardial infarction as accurate as gadolinium-based necrosis/fibrosis imaging;
- identify possible differences in infarct imaging using ferucarbotran for macrophage imaging compared to necrosis/fibrosis imaging with gadolinium-based compounds; and
- evaluate which MRI pulse-sequences maximise sensitivity for macrophage imaging with ferucarbotran in the setting of acute myocardial infarction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ferucarbotran | Experimental | Drug: Ferucarbotran (Resovist) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- acute myocardial infarction (STEMI or NSTEMI)
Key exclusion criteria (1 listed)
- contraindication to CMR or Magnevist® or Resovist®
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 |
|---|---|---|
| Ferucarbotran (Resovist)Also: Resovistsingle time intravenous bolus injection of a contrast agent | Drug | Ferucarbotran |
Primary outcome
Extent of myocardial infarction (as demonstrated with gadolinium-based necrosis/ fibrosis imaging compared to macrophage imaging using ferucarbotran)
Time frame: within 5 - 15 days after myocardial infarction
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 7 Nov 2014.
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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.
Udo Sechtem, MD study director
Robert Bosch Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ferucarbotran (Resovist) in people with Acute Myocardial Infarction, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 1 site in Germany.
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 1 inclusion and 1 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 7 Nov 2014. 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 Germany. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Extent of myocardial infarction (as demonstrated with gadolinium-based necrosis/ fibrosis imaging compared to macrophage imaging using ferucarbotran) (time frame: within 5 - 15 days after myocardial infarction). 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 7 Nov 2014.