Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock (CLOTILDE)
연구 개요
상태
정황
연구 유형
단계
- 2 단계
연락처 및 위치
연구 장소
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Aix-en-Provence, 프랑스, 13616
- CH Pays d'Aix
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Bayonne, 프랑스, 64100
- Clinique de La Fourcade
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Bron, 프랑스, 69677
- CHU Hopital Cardiologique Louis Pradel
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Clermont-ferrand, 프랑스, 63003
- Hôpital Gabriel Montpied
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Dijon, 프랑스, 21034
- CHU Hopital du Bocage
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Grenoble, 프랑스, 38043
- Chu Hopital A Michallon
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Lyon, 프랑스
- Hopital St Luc St Joseph
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Montpellier, 프랑스, 34295
- CHU Arnaud de Villeneuve
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Nantes, 프랑스, 44093
- Hopital Guillaume Et Rene Laennec
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Nimes, 프랑스, 30029
- CHU de Nîmes
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PAU, 프랑스, 64011
- Centre Hospitalier de Pau
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Paris, 프랑스, 75018
- APHP Hôpital Bichat
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Pessac, 프랑스, 33604
- CHU de Bordeaux
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Rouen, 프랑스, 76031
- Hôpital Charles Nicolle
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Strasbourg, 프랑스, 67091
- Nouvel hopital civil
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Toulouse, 프랑스, 31403
- CHU de Rangueil
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Tours, 프랑스, 37044
- CHRU de Tours
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Vandoeuvre Les Nancy, 프랑스, 54511
- CHU de Nancy Brabois
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: CsA Group
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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. |
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위약 비교기: 위약 그룹
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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multiorgan failure evaluated by the SOFA score
기간: At 24 hours after admission
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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.
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At 24 hours after admission
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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multiorgan failure by SOFA score
기간: At 48 hours after admission
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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.
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At 48 hours after admission
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multiorgan failure by SAPSII scores
기간: At 24 hours and at 48 hours
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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.
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At 24 hours and at 48 hours
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Cardiac output (CO)
기간: At 24 hours after inclusion
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The hemodynamic changes will be estimated by measuring the cardiac output (CO) obtained by echocardiography.
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At 24 hours after inclusion
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Reduction of infarct size
기간: during the first 72 hours after admission
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evaluation of the under curve area of serum creatinin kinase (CK) measured during the 72 first hours after admission (12 blood sampling).
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during the first 72 hours after admission
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Reduction of cardiovascular morbidity and mortality
기간: at 1 month
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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.
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at 1 month
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Reduction of Left ventricular remodeling
기간: at 1 month
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Left ventricular remodeling will be assessed at 1 month among surviving patients by measurement of left ventricular end-diastolic volume by transthoracic echocardiography
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at 1 month
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공동 작업자 및 조사자
수사관
- 수석 연구원: Eric Bonnefoy-Cudraz, MD, PhD, CHU-Hôpital Cardiologique Louis Pradel BRON
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2012.754
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