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Infarct size is a major determinant of vital prognosis after AMI. We recently reported that cyclosporine A, when administered immediately prior to PCI reperfusion, can significantly reduce infarct size in STEMI patients. The CIRCUS study aimed at determining the impact of cyclosporine on the combined incidence of (death, hospitalization for heart failure, LV remodelling) at one year after AMI. However, many patients may display increased adverse LV remodelling beyond year 1 and develop heart failure thereafter. The present CIRCUS II trial aims at examining the 3-year clinical outcome of all patients recruited in the CIRCUS study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporin | Experimental | one single intravenous bolus injection of 2.5 mg/Kg Echocardiography |
|
| Control | Placebo Comparator | one single intravenous bolus injection of Placebo Echocardiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of Cyclosporin | Drug | one single intravenous bolus injection of 2.5 mg/Kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)] | at 12 months post-AMI. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first event [total mortality, hospitalization for heart failure] | Functional outcome | until 3 years post-AMI |
| Total mortality | at 12 months post-AMI. |
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Inclusion Criteria:
And (further inclusion criteria to be confirmed by the admission coronary-angiography):
Patients undergoing either primary PCI or rescue PCI are eligible for the study. Patients with previous AMI, PCI or coronary artery bypass surgery (CABG) are eligible for the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel OVIZE, Prof | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Louis Pradel | Bron | France |
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| Placebo |
| Drug |
One single intravenous bolus injection of Placebo |
|
| Echocardiography | Procedure | 3 years after AMI |
|
| Total mortality | at 3 years post-AMI. |
| Cardiovascular death | at 3 years post-AMI. |
| Cardiovascular death | at 12 months post-AMI. |
| Heart failure | at 12 months post-AMI. |
| Heart failure | at 3 years post-AMI. |
| Myocardial infarction | at 12 months post-AMI. |
| Myocardial infarction | at 3 years post-AMI. |
| Unstable angina | at 12 months post-AMI. |
| Unstable angina | at 3 years post-AMI. |
| Stroke | at 12 months post-AMI. |
| Stroke | at 3 years post-AMI. |
| Infarct size | Measured by cardiac MRI, only for patients included in participating centers where cardiac MRI is part of the usual post-infarct care | at 12 months post-AMI. |
| Infarct size | Measured by cardiac MRI, only for patients included in participating centers where cardiac MRI is part of the usual post-infarct care | at 3 years post-AMI. |
| Quality of life | Assessed by the EQ-5D-3L | at 3 years post-AMI. |
| Adverse events | at 3 years post-AMI. |
| Ejection fraction | at 12 months post-AMI |
| Left-ventricular End-Diastolic Volume (LVEDV) | at 12 months post-AMI |
| Left-ventricular End-Systolic Volume (LVESV) | at 12 months post-AMI |
| Infarct size: peak Troponin (T or I) | at 4 hours (+/- 30 minutes) after study treatment administration |
| Microvascular obstruction | assessed by Magnetic resonance imaging | at 48 hours post-AMI |