Cyclosporine and Prognosis in Acute Myocardial Infarction (MI) Patients
- Conditions
- ST Elevation Acute Myocardial Infarction
- Interventions
- Registration Number
- NCT01502774
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
Infarct size is a major determinant of prognosis after Acute Myocardial Infarction (AMI). The investigators recently reported that cyclosporine A, when administered immediately prior to percutaneous coronary intervention (PCI), can significantly reduce infarct size in STEMI (ST Elevation acute Myocardial Infarction) patients. The objective of the present study is to determine whether cyclosporine can improve STEMI patient clinical outcome. Nine-hundred and seventy two patients with ST elevation MI will be entered into a multicentre, randomized, placebo-controlled, double-blinded study. They will receive one single injection of cyclosporine A (CicloMulsion, verum) or an equivalent volume of placebo prior to reperfusion therapy by PCI. The incidence of the combined endpoint (mortality, hospitalization for heart failure, left ventricular (LV) remodeling) will be assessed at one year and three years after treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 970
Eligibility criteria (for screening before hospital admission):
-
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.
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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.
- 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 5.2. known hypersensitivity to cyclosporine 5.3. known hypersensitivity to egg, peanut or Soya-bean proteins 5.4. known renal insufficiency (either known creatinin clearance < 30 ml/min/1.73m² or current medical care for severe renal insufficiency) 5.5. known liver insufficiency 5.6. 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 8.2. cancer, lymphoma 8.3. known positive serology for HIV, or hepatitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cyclosporin Injection of Cyclosporin Injection of Cyclosporin A : one single intravenous bolus injection of 2.5 mg/Kg Echocardiography Cyclosporin Echocardiography Injection of Cyclosporin A : one single intravenous bolus injection of 2.5 mg/Kg Echocardiography Control Placebo one single intravenous bolus injection of Placebo Echocardiography Control Echocardiography one single intravenous bolus injection of Placebo Echocardiography
- Primary Outcome Measures
Name Time Method Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)] at 1 year post-AMI
- Secondary Outcome Measures
Name Time Method Ejection fraction at 1 year Functional outcome
Unstable angina at 1 year Stroke at 1 year Infarct size at 1 year Measured by cardiac MRI, only for patients included in participating centers where cardiac MRI is part of the usual post-infarct care
Infarct size: peak Troponin (T or I) At admission and at 4 hours (+/- 30 minutes) after study treatment administration Explorative outcome. Cardiac prognostic factors.
Left-Ventricular End-Diastolic Volume (LVEDV) at 1 year Functional outcome
Left-Ventricular End-Systolic Volume (LVESV) at 1 year Functional outcome
Total mortality at 1 year Cardiovascular death at 1 year Heart failure at 1 year In-hospital worsening of heart failure after reperfusion, or rehospitalization for: a)worsening of a heart failure existing at admission, b)appearance of "new" heart failure
Myocardial infarction at 1 year Microvascular obstruction (no reflow) During hospitalization at admission Explorative outcome. Cardiac prognostic factors.
Trial Locations
- Locations (44)
Algemeen Ziekenhuis Sint-Jan Brugge
🇧🇪Brugge, Belgium
Hôpital Henri Duffaut
🇫🇷Avignon, France
CHRU- Hôpital de la Côte de Nacre
🇫🇷Caen, France
Institut Jacques Cartier
🇫🇷Massy, France
Clinique du Millénaire
🇫🇷Montpellier, France
Hôpital Charles NICOLLE
🇫🇷Rouen, France
Centre Hospitalier du Pays D'Aix
🇫🇷Aix En Provence, France
CHU Mont-Godinne
🇧🇪Yvoir, Belgium
Centre Hospitalier General
🇫🇷Hagueneau, France
Hôpital Claude Galien
🇫🇷Quincy Sous Senart, France
Hôpital universitaire d'Anvers (UZA)
🇧🇪Edegem, Belgium
Clinique ESQUIROL - SAINT-HILAIRE
🇫🇷Agen, France
Clinique de l'Ormeau - CCV des Pyrénées
🇫🇷Tarbes, France
CHU de Rangueil
🇫🇷Toulouse, France
Centre Hospitalier Universitaire d'Angers
🇫🇷Angers, France
Hôpital Haut Lévêque
🇫🇷Pessac, France
Hôpital Pontchaillou
🇫🇷Rennes, France
CH de Pau
🇫🇷PAU, France
Clinique Saint Gatien
🇫🇷Tours, France
CHU - Hôpital Gabriel Montpied
🇫🇷Clermont Ferrand, France
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hôpital du Bocage
🇫🇷Dijon, France
Hôpitaux Universitaires, Nouvel Hôpital Civil
🇫🇷Strasbourg, France
Chu Charleroi
🇧🇪Charleroi, Belgium
CHU Arnaud de Villeneuve
🇫🇷Montpellier, France
Hôpital Brabois - CHU Nancy
🇫🇷Vandoeuvre Les Nancy, France
Centre Hospitalier d'Annecy
🇫🇷Annecy, France
Hopital Louis Pradel, Hospices Civils de Lyon
🇫🇷Bron cedex, France
CHRU - Hôpital Cardiologique Calmette
🇫🇷Lille, France
CH de Compiègne
🇫🇷Compiegne, France
Clinique du Diaconat
🇫🇷Mulhouse, France
Centre Hospitalier St Luc St Joseph
🇫🇷Lyon, France
Hôpital Guillaume et René Laennec
🇫🇷Nantes, France
Polyclinique des Fleurs
🇫🇷Ollioules, France
CHU de Nîmes
🇫🇷Nimes, France
APHP Hôpital Bichat
🇫🇷Paris, France
Clinique du Tonkin
🇫🇷Villeurbanne, France
CHRU de Tours
🇫🇷Tours, France
Centre Hospitalier Universitaire
🇫🇷Brest, France
Clinique Lafourcade
🇫🇷Bayonne, France
Clinique de la Sauvegarde
🇫🇷Lyon, France
CH Henri MONDOR
🇫🇷Creteil, France
Hôpital A. MICHALLON - CHU
🇫🇷Grenoble, France
CHU de Mulhouse
🇫🇷Mulhouse, France