Subacute/Chronic Myocardial InfarctionPhase 2GadovitNCT01655290
Comparison of Gadobutrol and Gadobenate Dimeglumin for Delayed Enhancement Cardiac MRI
A Phase 2 study testing Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin) in people with Subacute/Chronic Myocardial Infarction, run by Technical University of Munich at 1 site in Germany.
Trial summary
This study aims at evaluating the diagnostic efficacy of Gadobutrol versus Gadobenate dimeglumine at similar dose of 0.1mmol/kg for assessment of myocardial infarction by delayed enhancement cardiac Magnetic Resonance Imaging Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subacute/Chronic Myocardial Infarction
- What is being tested?
- Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Jun 2014
- Phase
- Phase 2
- 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
- Diagnosis of myocardial infarction
- Age ≥ 18 years and ≤ 80 years
- Informed consent
- Male patients as well as female patients using contraceptives
Who cannot join
- Patients with a heart pacemaker, with magnetic material or other magnetic implants.
- Renal failure (GFR <30ml/min)
- Patients with known allergy to a Gadolinium-containing contrast agent
- Drugs or alcohol addiction, dementia
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Radiologie - Klinikum Rechts der Isar
Munich, Bavaria, 81675
About this study
Official title: Single Dose Gadobutrol in Comparison to Single Dose Gadobenate Dimeglumine for Magnetic Resonance Imaging of Chronic Myocardial Infarction at 3 Tesla
This study aims at evaluating the diagnostic efficacy of Gadobutrol versus Gadobenate dimeglumine at similar dose of 0.1mmol/kg for assessment of myocardial infarction by delayed enhancement cardiac Magnetic Resonance Imaging
- Conditions
- Subacute/Chronic Myocardial Infarction
- Being tested
- Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)Other
Other (Diagnostic)
| Study group | Role | What they receive |
|---|---|---|
| Gadobutrol | Experimental | first session gadobutrol second session gadobenate dimeglumin Receives: Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin) |
| Demeglumin | Experimental | first session gadobenate dimeglumin second session gadobutrol Receives: Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (contrast-to-noise ratio)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacute/Chronic Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655290
- Sponsor's protocol ID
- GAD-1140-WIL-0020-I
- Acronym
- Gadovit
- Status last verified
- Oct 2020
- First submitted
- 30 Jul 2012
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Gadobutrol in Comparison to Single Dose Gadobenate Dimeglumine for Magnetic Resonance Imaging of Chronic Myocardial Infarction at 3 Tesla
- ClinicalTrials.gov ID
- NCT01655290
- Acronym / sponsor ID
- Gadovit / GAD-1140-WIL-0020-I
- Conditions
- Subacute/Chronic Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 Aug 2012 (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.
This study aims at evaluating the diagnostic efficacy of Gadobutrol versus Gadobenate dimeglumine at similar dose of 0.1mmol/kg for assessment of myocardial infarction by delayed enhancement cardiac Magnetic Resonance Imaging
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gadobutrol | Experimental | Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)first session gadobutrol second session gadobenate dimeglumin |
| Demeglumin | Experimental | Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)first session gadobenate dimeglumin second session gadobutrol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of myocardial infarction
- Age ≥ 18 years and ≤ 80 years
- Informed consent
- Male patients as well as female patients using contraceptives
Key exclusion criteria (4 listed)
- Patients with a heart pacemaker, with magnetic material or other magnetic implants.
- Renal failure (GFR <30ml/min)
- Patients with known allergy to a Gadolinium-containing contrast agent
- Drugs or alcohol addiction, dementia
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 |
|---|---|---|
| Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)Other (Diagnostic) | Other | Demeglumin, Gadobutrol |
Primary outcome
Efficacy (contrast-to-noise ratio)
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 22 Oct 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin) in people with Subacute/Chronic Myocardial Infarction, run by Technical University of Munich 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 4 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 22 Oct 2020. 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 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.
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?
Efficacy (contrast-to-noise ratio). 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 22 Oct 2020.