Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock

Last updated: March 15, 2016
Sponsor: Hospices Civils de Lyon
Overall Status: Trial Not Available

Phase

2

Condition

Coronary Artery Disease

Occlusions

Angina

Treatment

N/A

Clinical Study ID

NCT01901471
2012.754
  • Ages > 18
  • All Genders

Study Summary

The size of the acute myocardial infarction (AMI) is related to ischemia and injury induced by tissue reperfusion. These reperfusion's injuries can be reduced by injection of cyclosporin A (CsA) at the time of reperfusion. This post-conditioning reduces the final infarct size 20 to 40%. This has been demonstrated in STEMI patients non-complicated by cardiogenic shock. Early revascularization in the AMI complicated by cardiogenic shock improves short-term and long term survival by reducing the size of the myocardial infarction. The hypothesis of this study is that the administration of Cyclosporin A to these patients, in addition to mechanical reperfusion, is likely to reduce the severity of the multi-organ failure associated with the cardiogenic shock and improve clinical outcome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ( male or female), aged over 18, without any legal protection measure

  • Having a health coverage

  • Presenting within 12 hours of the onset of chest pain, with a ST segment elevation ornon ST elevation and for whom the clinical decision was made to treat withpercutaneous coronary intervention (PCI) primary or rescue

  • Occlusion of culprit coronary artery (TIMI flow grade = 0 or 1) at the time ofadmission in the catheterism laboratory

  • Patient presenting a cardiogenic shock defined by a SBP<90mmhg for a period over 30minutes and do not answering to a test of vascular charge associated with signsperipheral hypoperfusion (cold extremities, cyanosis, oliguria with urine output <50ml/h or alteration of higher mental functions).

  • Clear information is delivered to the patient or a legal representative if present andpreliminary oral consent obtained, followed by obtaining written consent signed assoon as possible, in accordance with ICH. NB: 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 forthe study.

Exclusion

Exclusion Criteria:

  • TIMI flow grade >1

  • Patients in cardiac arrest

  • Patients with mechanical complication of myocardial infarction at admission (septal,broken pillar cracking or myocardial rupture, tamponade).

  • Patients with other causes of hemodynamic shock: hemorrhagic, septic or anaphylactic.

  • Patients with known hypersensitivity to cyclosporine, hypersensitivity to egg, peanutor Soya-bean proteins

  • Renal insufficiency (either known creatinine clearance < 30 ml/min/1.73m² or currentmedical care for severe renal insufficiency)

  • Patients treated with any compound containing Hypericum perforatum (St. John's Wort)or Stiripentol or Aliskiren or Bosentan or Rosuvastatine

  • Female patients currently pregnant or women of childbearing age who were not usingcontraception (oral diagnosis).

  • Patients with any disorder associated with immunological dysfunction more recentlythan 6 months prior to presentation, cancer, lymphoma, known positive serology forHIV, or hepatitis

  • Participation to another clinical trial

Study Design

Study Start date:
September 01, 2015
Estimated Completion Date:
October 31, 2015

Connect with a study center

  • CH Pays d'Aix

    Aix-en-Provence, 13616
    France

    Site Not Available

  • Clinique de La Fourcade

    Bayonne, 64100
    France

    Site Not Available

  • CHU Hopital Cardiologique Louis Pradel

    Bron, 69677
    France

    Site Not Available

  • Hôpital Gabriel Montpied

    Clermont-ferrand, 63003
    France

    Site Not Available

  • Chu Hopital Du Bocage

    Dijon, 21034
    France

    Site Not Available

  • Chu Hopital A Michallon

    Grenoble, 38043
    France

    Site Not Available

  • Hopital St Luc St Joseph

    Lyon,
    France

    Site Not Available

  • Chu Arnaud de Villeneuve

    Montpellier, 34295
    France

    Site Not Available

  • Hopital Guillaume Et Rene Laennec

    Nantes, 44093
    France

    Site Not Available

  • Chu de Nimes

    Nimes, 30029
    France

    Site Not Available

  • Centre Hospitalier de Pau

    PAU, 64011
    France

    Site Not Available

  • Aphp Hopital Bichat

    Paris, 75018
    France

    Site Not Available

  • Chu de Bordeaux

    Pessac, 33604
    France

    Site Not Available

  • Hopital Charles Nicolle

    Rouen, 76031
    France

    Site Not Available

  • Nouvel Hôpital Civil

    Strasbourg, 67091
    France

    Site Not Available

  • Chu de Rangueil

    Toulouse, 31403
    France

    Site Not Available

  • Chru de Tours

    Tours, 37044
    France

    Site Not Available

  • Chu de Nancy Brabois

    Vandoeuvre Les Nancy, 54511
    France

    Site Not Available

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