Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock (CLOTILDE)
調査の概要
状態
条件
研究の種類
段階
- フェーズ2
連絡先と場所
研究場所
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Aix-en-Provence、フランス、13616
- Ch Pays D'Aix
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Bayonne、フランス、64100
- Clinique de La Fourcade
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Bron、フランス、69677
- CHU Hopital Cardiologique Louis Pradel
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Clermont-ferrand、フランス、63003
- Hopital Gabriel Montpied
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Dijon、フランス、21034
- CHU Hôpital du Bocage
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Grenoble、フランス、38043
- Chu Hopital A Michallon
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Lyon、フランス
- Hopital St Luc St Joseph
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Montpellier、フランス、34295
- CHU Arnaud de Villeneuve
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Nantes、フランス、44093
- Hopital Guillaume Et Rene Laennec
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Nimes、フランス、30029
- CHU de Nîmes
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PAU、フランス、64011
- Centre Hospitalier de Pau
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Paris、フランス、75018
- APHP Hôpital Bichat
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Pessac、フランス、33604
- Chu de Bordeaux
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Rouen、フランス、76031
- Hopital Charles Nicolle
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Strasbourg、フランス、67091
- Nouvel Hôpital Civil
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Toulouse、フランス、31403
- CHU de Rangueil
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Tours、フランス、37044
- CHRU de TOURS
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Vandoeuvre Les Nancy、フランス、54511
- CHU de Nancy Brabois
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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プラセボコンパレーター：プラセボ群
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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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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multiorgan failure evaluated by the SOFA score
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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multiorgan failure by SOFA score
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Eric Bonnefoy-Cudraz, MD, PhD、CHU-Hôpital Cardiologique Louis Pradel BRON
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2012.754
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。