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lack of recruitment
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The main objective of this study is to compare the proportions of late enhancement in patients with Left ventricular (LV) dysfunction as Herceptin ® and in a control group consisting of patients who did not have LV dysfunction after 6 months under the same treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LV dysfunction group | Other | Cardiac MRI |
|
| Control group | Other | Cardiac MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac MRI | Other | The examinations will be conducted on an MRI with a dedicated antenna heart, by a physician with expertise in cardiac MRI. After establishing a good quality ECG synchronization, the following sequences are carried out successively:
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of late enhancement in patients with LV dysfunction as Herceptin ® and in a control group consisting of patients who did not have LV dysfunction after 6 months under the same treatment. | A cardiac MRI is considered positive if demonstrated a late hyperintense from 15 to 20 minutes after injection of gadolinium chelate, whatever its size, topography subepicardial (intramyocardial) and without vascular systematization. The primary endpoint is the proportion of delayed enhancement in the LV dysfunction group and the control group. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients recovering at 6 months in the absence of late enhancement signal in MRI heart after injection of gadolinium and compare the results of biological assays | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MANRIQUE Alain, Pr | GIP Cyceron | Study Chair |
| SWITSERS Odile, Dr | Centre François Baclesse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre François Baclesse | Caen | 14076 | France | |||
| Centre Georges-François Leclerc |
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|
| Dijon |
| France |
| Clinique du Bois | Lille | France |
| CHU de NANCY | Nancy | 54511 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018487 | Ventricular Dysfunction, Left |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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