Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock (CLOTILDE)

15. marts 2016 opdateret af: Hospices Civils de Lyon
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.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Aix-en-Provence, Frankrig, 13616
        • CH Pays d'Aix
      • Bayonne, Frankrig, 64100
        • Clinique de La Fourcade
      • Bron, Frankrig, 69677
        • CHU Hopital Cardiologique Louis Pradel
      • Clermont-ferrand, Frankrig, 63003
        • Hôpital Gabriel Montpied
      • Dijon, Frankrig, 21034
        • CHU Hopital du Bocage
      • Grenoble, Frankrig, 38043
        • Chu Hopital A Michallon
      • Lyon, Frankrig
        • Hopital St Luc St Joseph
      • Montpellier, Frankrig, 34295
        • CHU Arnaud de Villeneuve
      • Nantes, Frankrig, 44093
        • Hôpital Guillaume et René Laënnec
      • Nimes, Frankrig, 30029
        • CHU de Nimes
      • PAU, Frankrig, 64011
        • Centre Hospitalier de Pau
      • Paris, Frankrig, 75018
        • APHP Hôpital Bichat
      • Pessac, Frankrig, 33604
        • CHU de Bordeaux
      • Rouen, Frankrig, 76031
        • Hôpital Charles Nicolle
      • Strasbourg, Frankrig, 67091
        • Nouvel Hopital Civil
      • Toulouse, Frankrig, 31403
        • CHU de Rangueil
      • Tours, Frankrig, 37044
        • Chru de Tours
      • Vandoeuvre Les Nancy, Frankrig, 54511
        • CHU de Nancy Brabois

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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 or non ST elevation and for whom the clinical decision was made to treat with percutaneous coronary intervention (PCI) primary or rescue
  • Occlusion of culprit coronary artery (TIMI flow grade = 0 or 1) at the time of admission in the catheterism laboratory
  • Patient presenting a cardiogenic shock defined by a SBP<90mmhg for a period over 30 minutes and do not answering to a test of vascular charge associated with signs peripheral hypoperfusion (cold extremities, cyanosis, oliguria with urine output <50 ml/h or alteration of higher mental functions).
  • Clear information is delivered to the patient or a legal representative if present and preliminary oral consent obtained, followed by obtaining written consent signed as soon 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 for the study.

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, peanut or Soya-bean proteins
  • Renal insufficiency (either known creatinine clearance < 30 ml/min/1.73m² or current medical 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 using contraception (oral diagnosis).
  • Patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation, cancer, lymphoma, known positive serology for HIV, or hepatitis
  • Participation to another clinical trial

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CsA Group
Medicin: Single bolus of cyclosporine A (CicloMulsion®, Neurovive)

The investigational medicinal product is cyclosporine A (CicloMulsion®, Neurovive).

Cyclosporine A is an immunosuppressive treatment usually used in the prevention of acute rejection after organ transplant, including cardiac transplantation. Usual dosages in organ transplantation are about 2.5 mg / kg per day in 2 doses.

CicloMulsion® is ready-to-use lipid emulsions, i.e. do not need any step of preparation or dilution.

Production blinded labelling, packaging and delivering the study drugs in every participating centre of the trial will be performed by a company following European Union's Good Manufacturing Practice.

CicloMulsion® 5mg/ml is provided in colourless glass bottles sealed with a rubber stopper, containing a nominal fill volume of 50 ml.

The study treatment will be directly taken into the vial and injected via a catheter positioned within an antecubital vein. The injection will be performed slowly over 2 to 3 minutes.
Placebo komparator: Placebo gruppe
Medicin: Single bolus of Placebo of CicloMulsion® (Neurovive).

The matching placebo of CicloMulsion® (Neurovive) is composed with refined Soya-bean oil, medium-chain triglycerides, egg lecithin, water-free glycerol, sodium oleate, sodium hydroxide, water injection. The qualitative composition of CicloMulsion® and its placebo only differ in the presence or absence of Cyclosporine A, so the final emulsions will be visually indistinguishable.

The placebo use here is ready-to-use lipid emulsions, i.e. do not need any step of preparation or dilution.

The placebo is provided in colourless glass bottles sealed with a rubber stopper, containing a nominal fill volume of 50 ml.

The study treatment will be directly taken into the vial and injected via a catheter positioned within an antecubital vein. The injection will be performed slowly over 2 to 3 minutes.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
multiorgan failure evaluated by the SOFA score
Tidsramme: At 24 hours after admission
The SOFA clinico-biological score takes into account the respiratory status, cardiac, hepatic, renal, neurological and the biological parameters of coagulation of the patient. This score is spread from 0 to 24 points.
At 24 hours after admission

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
multiorgan failure by SOFA score
Tidsramme: At 48 hours after admission
The SOFA clinico-biological score takes into account the respiratory status, cardiac, hepatic, renal,neurological and the biological parameters of coagulation of the patient. This score is spread from 0 to 24 points.
At 48 hours after admission
multiorgan failure by SAPSII scores
Tidsramme: At 24 hours and at 48 hours
The SAPSII score takes into account the hemodynamic, clinical, biological status of the patient. The parameters are : history of patient (type of admission, chronic disease, age), clinical parameters as systolic pressure measurement, heart rate, temperature, urine output of 24 hours and biological parameters as measurement of blood count white, serum total bilirubin, serum urea, serum sodium, serum potassium and bicarbonate level serum. pressure measurement arterial oxygen in arterial blood gases. This score is spread from 0 to 163 points.
At 24 hours and at 48 hours
Cardiac output (CO)
Tidsramme: At 24 hours after inclusion
The hemodynamic changes will be estimated by measuring the cardiac output (CO) obtained by echocardiography.
At 24 hours after inclusion
Reduction of infarct size
Tidsramme: during the first 72 hours after admission
evaluation of the under curve area of serum creatinin kinase (CK) measured during the 72 first hours after admission (12 blood sampling).
during the first 72 hours after admission
Reduction of cardiovascular morbidity and mortality
Tidsramme: at 1 month
The incidence that occurred in one month (D30) of the following clinical criteria will be collected: death, ventricular fibrillation or ventricular tachycardia requiring electrical cardioversion, placed under mechanical cardiac support (other than against drive-by intra-aortic balloon) , reinfarction, hospitalization for heart failure.
at 1 month
Reduction of Left ventricular remodeling
Tidsramme: at 1 month
Left ventricular remodeling will be assessed at 1 month among surviving patients by measurement of left ventricular end-diastolic volume by transthoracic echocardiography
at 1 month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospices Civils de Lyon

Efterforskere

  • Ledende efterforsker: Eric Bonnefoy-Cudraz, MD, PhD, CHU-Hôpital Cardiologique Louis Pradel BRON

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2015

Primær færdiggørelse (Forventet)

1. oktober 2015

Studieafslutning (Forventet)

1. oktober 2015

Datoer for studieregistrering

Først indsendt

11. juli 2013

Først indsendt, der opfyldte QC-kriterier

15. juli 2013

Først opslået (Skøn)

17. juli 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2012.754

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Akut myokardieinfarkt

Kliniske forsøg med Single bolus of cyclosporine A (CicloMulsion®, Neurovive)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Indonesia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner