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| ID | Type | Description | Link |
|---|---|---|---|
| DE-03899 | |||
| 306947 |
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The purpose of this study is to determine the dose of drug which is most effective in the delineation of dead heart muscle.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 2 | Experimental |
| |
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative measurement of the total area of delayed enhancement | 30 min post injection |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative measures of area of delayed enhancement and signal intensities | At 5, 10 and 20 minutes post injection | |
| Semiquantitative measures of area of delayed enhancement | At 5, 10, 20 and 30 minutes post injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | 92103 | United States | |||
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| 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 |
|
| Presence of delayed enhancement | At 5,10 and 20 minutes post injection |
| Wall motion endpoints | Pre-injection |
| Safety | From baseline to 24h follow-up of second imaging |
| Winston-Salem |
| North Carolina |
| 27103 |
| United States |
| Tulsa | Oklahoma | 74133 | United States |
| Portland | Oregon | 97239 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Pittsburgh | Pennsylvania | 15212-4772 | United States |
| Buenos Aires | Buenos Aires | C1428BKN | Argentina |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D019786 | Gadolinium DTPA |
| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |
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