ST Elevation Acute Myocardial Infarction
Conditions
Brief summary
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.
Interventions
one single intravenous bolus injection of 2.5 mg/Kg
DRUGPlacebo
One single intravenous bolus injection of Placebo
PROCEDUREEchocardiography
3 years after AMI
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All (male and female) patients, aged over 18, without any legal protection measure, * Having a health coverage, * Presenting within 12 hours of the onset of chest pain, * Who have ST segment elevation ≥0.2 mV in two contiguous leads, * For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI). And (further inclusion criteria to be confirmed by the admission coronary-angiography): * The culprit coronary artery has to be the LAD * The LAD artery has to be occluded (TIMI flow grade 0-1) at the time of admission coronary angiography. * Preliminary oral informed consent followed by signed informed consent as soon as possible. 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
* Patients with loss of consciousness or confused * Patients with cardiogenic shock * Patients with the left circumflex or the right coronary artery (RCA) as the culprit artery, or with evidence of coronary collaterals to the risk region * Patients with an opened (TIMI \> 1) LAD coronary artery at admission on initial (admission) coronary angiography * Patients with 1. known hypersensitivity to cyclosporine 2. known hypersensitivity to egg, peanut or Soya-bean proteins 3. known renal insufficiency (either known creatinin clearance \< 30 ml/min/1.73m² or current medical care for severe renal insufficiency) 4. known liver insufficiency 5. uncontrolled (treated or untreated) hypertension (\> 180/110 mmHg) * Patients treated with any compound containing Hypericum perforatum (St.-John's-worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine * Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis). * Patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation 1. cancer, lymphoma 2. known positive serology for HIV, or hepatitis
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unstable angina | at 12 months post-AMI. | — |
| Stroke | at 12 months post-AMI. | — |
| Infarct size | at 12 months post-AMI. | Measured by cardiac MRI, only for patients included in participating centers where cardiac MRI is part of the usual post-infarct care |
| Quality of life | at 3 years post-AMI. | Assessed by the EQ-5D-3L |
| 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 | — |
| Myocardial infarction | at 12 months post-AMI. | — |
| Infarct size: peak Troponin (T or I) | at 4 hours (+/- 30 minutes) after study treatment administration | — |
| Microvascular obstruction | at 48 hours post-AMI | assessed by Magnetic resonance imaging |
| Time to first event [total mortality, hospitalization for heart failure] | until 3 years post-AMI | Functional outcome |
| Total mortality | at 12 months post-AMI. | — |
| Cardiovascular death | at 3 years post-AMI. | — |
| Heart failure | at 12 months post-AMI. | — |
| Left-ventricular End-Systolic Volume (LVESV) | at 12 months post-AMI | — |
Countries
France
Outcome results
None listed