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Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction
This study has been completed.
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00310544
First received: March 31, 2006
Last updated: December 11, 2014
Last verified: December 2014
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Purpose
The purpose of this study is to determine the dose of drug which is most effective in the delineation of dead heart muscle.
| Condition | Intervention | Phase |
|---|---|---|
| Myocardial Infarction | Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882) | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Quantitative measurement of the total area of delayed enhancement [ Time Frame: 30 min post injection ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 73 |
| Study Start Date: | March 2006 |
| Study Completion Date: | September 2006 |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310544
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310544
Locations
| 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 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00310544 History of Changes |
| Other Study ID Numbers: |
91230 DE-03899 306947 |
| Study First Received: | March 31, 2006 |
| Last Updated: | December 11, 2014 |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on September 21, 2017