Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction
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ClinicalTrials.gov Identifier: NCT00310544 |
Recruitment Status :
Completed
First Posted : April 4, 2006
Last Update Posted : December 15, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myocardial Infarction | Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 73 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Diagnostic |
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 |
Study Start Date : | March 2006 |
Actual Study Completion Date : | September 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 2 |
Drug: 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 |
Experimental: Arm 1 |
Drug: 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 |
- Quantitative measurement of the total area of delayed enhancement [ Time Frame: 30 min post injection ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- At least 8 weeks post-documented myocardial infarction (heart attack)
Exclusion Criteria:
- History of radiation therapy to the chest
- Clinically unstable
- Any contraindication for MRI

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310544
United States, California | |
San Diego, California, United States, 92103 | |
United States, North Carolina | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Oklahoma | |
Tulsa, Oklahoma, United States, 74133 | |
United States, Oregon | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Hershey, Pennsylvania, United States, 17033 | |
Pittsburgh, Pennsylvania, United States, 15212-4772 | |
Argentina | |
Buenos Aires, Argentina, C1428BKN |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT00310544 |
Other Study ID Numbers: |
91230 DE-03899 306947 |
First Posted: | April 4, 2006 Key Record Dates |
Last Update Posted: | December 15, 2014 |
Last Verified: | December 2014 |
Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |