Acute myocardial infarction, ST segment elevation myocardial infarction
Conditions
Brief summary
The primary endpoint is the left ventricular ejection fraction (LVEF) by CMR at 6 months.
Detailed description
• Infarct size by CMRI (using T1-weighted late gadolinium enhancement, LGE) between day 3 and day 7 (52) and at 6 months., Oedema extension by CMRI (using T2W) between day 3 and day 7 (5±2), T2 relaxation time at ischemic region by CMRI (using T2 mapping) between day 3 and day 7 (5±2), Microvascular obstruction by CMRI (hypointense areas within LGE) between day 3 and day 7 (5±2), NT-pro-BNP at 6 months, Any adverse event related to treatment
Interventions
DRUGMabThera 500 mg concentrate for solution for infusion
DRUGSODIUM CHLORIDE
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the left ventricular ejection fraction (LVEF) by CMR at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Infarct size by CMRI (using T1-weighted late gadolinium enhancement, LGE) between day 3 and day 7 (52) and at 6 months., Oedema extension by CMRI (using T2W) between day 3 and day 7 (5±2), T2 relaxation time at ischemic region by CMRI (using T2 mapping) between day 3 and day 7 (5±2), Microvascular obstruction by CMRI (hypointense areas within LGE) between day 3 and day 7 (5±2), NT-pro-BNP at 6 months, Any adverse event related to treatment | — |
Countries
Czechia, France, Germany, Netherlands, Spain
Outcome results
None listed