Myocardial InfarctionPhase 2NCT00310544
Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction
A Phase 2 study testing Magnevist (Gadopentetate dimeglumine, BAY86-4882) in people with Myocardial Infarction, run by Bayer at 7 sites in 2 countries.
Trial summary
The purpose of this study is to determine the dose of drug which is most effective in the delineation of dead heart muscle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Magnevist (Gadopentetate dimeglumine, BAY86-4882)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Mar 2006to Sep 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 8 weeks post-documented myocardial infarction (heart attack)
Who cannot join
- History of radiation therapy to the chest
- Clinically unstable
- Any contraindication for MRI
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Study site
Hershey, Pennsylvania, 17033
Study site
Pittsburgh, Pennsylvania, 15212-4772
Study site
Portland, Oregon, 97239
Study site
San Diego, California, 92103
Study site
Tulsa, Oklahoma, 74133
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: Multicenter, Single-blind, Randomized, Intraindividual Study of the Safety and Efficacy of Magnevist Gadopentetate Dimeglumine (Magnevist® Injection) at 0.1 and 0.2 mmol/kg for the Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction
The purpose of this study is to determine the dose of drug which is most effective in the delineation of dead heart muscle.
Read the detailed description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
- Conditions
- Myocardial Infarction
- Being tested
- Magnevist (Gadopentetate dimeglumine, BAY86-4882)
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnevist (Gadopentetate dimeglumine, BAY86-4882)Drug
One intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days.period1:Magnevist 0.1 mmol/kg body weightperiod 2: Magnevist 0.2 mmol/kg body weight
Magnevist (Gadopentetate dimeglumine, BAY86-4882)Drug
One intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days.period 1: Magnevist 0.2 mmol/kg body weightperiod 2: Magnevist 0.1 mmol/kg body weight
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 | Experimental | Not described Receives: Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882) |
| Arm 1 | Experimental | Not described Receives: Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative measurement of the total area of delayed enhancement
Measured: 30 min post injection
Secondary outcomes (5)
Quantitative measures of area of delayed enhancement and signal intensities
Measured: At 5, 10 and 20 minutes post injection
Semiquantitative measures of area of delayed enhancement
Measured: At 5, 10, 20 and 30 minutes post injection
Presence of delayed enhancement
Measured: At 5,10 and 20 minutes post injection
Wall motion endpoints
Measured: Pre-injection
Safety
Measured: From baseline to 24h follow-up of second imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2006 (estimated)
- Study startMar 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310544
- Sponsor's protocol ID
- 91230
- Other IDs
- DE-03899, 306947
- Status last verified
- Dec 2014
- First submitted
- 31 Mar 2006
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Single-blind, Randomized, Intraindividual Study of the Safety and Efficacy of Magnevist Gadopentetate Dimeglumine (Magnevist® Injection) at 0.1 and 0.2 mmol/kg for the Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00310544
- Acronym / sponsor ID
- 91230
- Conditions
- Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Sep 2006 (actual)
- First posted
- 4 Apr 2006 (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 purpose of this study is to determine the dose of drug which is most effective in the delineation of dead heart muscle.
Detailed description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 2 | Experimental | Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882) |
| Arm 1 | Experimental | Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 8 weeks post-documented myocardial infarction (heart attack)
Key exclusion criteria (3 listed)
- History of radiation therapy to the chest
- Clinically unstable
- Any contraindication for MRI
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 |
|---|---|---|
| Magnevist (Gadopentetate dimeglumine, BAY86-4882)One intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days.period1:Magnevist 0.1 mmol/kg body weightperiod 2: Magnevist 0.2 mmol/kg body weight | Drug | Arm 1 |
| Magnevist (Gadopentetate dimeglumine, BAY86-4882)One intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days.period 1: Magnevist 0.2 mmol/kg body weightperiod 2: Magnevist 0.1 mmol/kg body weight | Drug | Arm 2 |
Primary outcome
Quantitative measurement of the total area of delayed enhancement
Time frame: 30 min post injection
5 secondary outcomes
Quantitative measures of area of delayed enhancement and signal intensities
Time frame: At 5, 10 and 20 minutes post injection
Semiquantitative measures of area of delayed enhancement
Time frame: At 5, 10, 20 and 30 minutes post injection
Presence of delayed enhancement
Time frame: At 5,10 and 20 minutes post injection
Wall motion endpoints
Time frame: Pre-injection
Safety
Time frame: From baseline to 24h follow-up of second imaging
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 15 Dec 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.
Bayer Study Director study director
Bayer
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnevist (Gadopentetate dimeglumine, BAY86-4882) in people with Myocardial Infarction, run by Bayer at 7 sites in 2 countries.
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 3 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 15 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Argentina. 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?
Quantitative measurement of the total area of delayed enhancement (time frame: 30 min post 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 15 Dec 2014.