NCT03947619进行中（未招募）不适用
Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Abiomed Inc.
- 入组人数
- 527
- 试验地点
- 63
- 主要终点
- Infarct Size
研究概览
简要总结
The purpose of this research study is to evaluate whether using the the IMPELLA® CP System temporary circulatory assist device for 30 minutes prior to a catheterization procedure has the potential to reduce the damage to the heart caused by a heart attack, compared to the current standard of care.
详细描述
To demonstrate the safety and effectiveness of primary Left Ventricular unloading and a thirty-minutes delay to reperfusion vs. current standard of care in reducing infarct size and heart failure-related clinical events in patients presenting with anterior ST-Elevation Myocardial Infarction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of the operator and patient is not possible given the nature of the treatment.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years
- •First myocardial infarction
- •Acute anterior STEMI with ≥2 mm in 2 or more contiguous anterior leads or ≥ 4 mm total ST segment deviation sum in the anterior leads V1-V4 AND anterior wall motion abnormality noted on a diagnostic quality left ventriculogram or echocardiogram
- •Patient presents to the enrolling hospital where the index procedure will be performed between 1 - 6 hours after onset of continuous ischemic pain
- •Patient indicated for Primary PCI
- •Patient or the patient's Legally Authorized Representative (where applicable) has signed Informed Consent
排除标准
- •Patient transferred from an outside hospital where invasive coronary procedure was attempted (including diagnostic catheterization)
- •Unwitnessed cardiac arrest OR ≥30 minutes of CPR prior to enrollment OR any cardiac arrest with impairment in mental status, cognition, or any global or focal neurological deficit
- •Administration of fibrinolytic therapy within 24 hours prior to enrollment
- •Cardiogenic shock defined as: systemic hypotension (systolic BP <90 mmHg or the need for inotropes/pressors to maintain a systolic BP >90mmHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the catheterization laboratory, clinical evidence of end organ hypoperfusion or use of IABP or any other circulatory support device
- •Inferior STEMI or suspected right ventricular failure
- •Any contraindication or inability to place the Impella, including peripheral vascular disease, tortuous vascular anatomy, femoral bruits or absent pedal pulses
- •Severe aortic stenosis
- •Acute cardiac mechanical complication: LV free wall rupture OR Interventricular septum rupture OR Acute mitral regurgitation
- •Suspected or known pregnancy
- •Suspected systemic active infection
- •History or known hepatic insufficiency prior to catheterization
- •On renal replacement therapy
- •COPD with home oxygen therapy or on chronic steroid therapy
- •Known or evidence of prior myocardial infarction, including pathologic Q waves in non-anterior leads
- •Prior CABG or LAD PCI
- •History of heart failure (documented history of EF <40% or documented hospitalization for HF within one (1) year prior to screening)
- •Prior aortic valve surgery or TAVR
- •Left bundle branch block (new or old)
- •History of stroke/TIA within the prior 3 months, any history of Intracranial Hemorrhage or any permanent neurological deficit
- •History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent GU or GI bleed, or will refuse blood transfusions
- •Patient on systemic anticoagulation pre-procedure (including factor Xa inhibitors, thrombin inhibitors, warfarin)
- •Known contraindication to:
- •Undergoing MRI or use of gadolinium, [CrCl<30 ml/min, non-compatible implant, claustrophobia]
- •Heparin, pork, pork products or contrast media
- •Receiving a drug-eluting stent
- •Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary endpoint.
- •Any organ condition, concomitant disease (e.g., psychiatric illness, severe alcoholism, or drug abuse, severe cancer, hepatic or kidney disease), with life expectancy of ≤2 years or other abnormality that itself, or the treatment of which, could interfere with the conduct of the study or that, in the opinion of the Investigator and/or Sponsor's medical monitor, would pose an unacceptable risk to the patient in the study.
- •Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures, including follow-up CMRs.
- •Subject belongs to a vulnerable population [Vulnerable patient populations are defined as Individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, prisoners, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, and members of the armed forces.
- •A pregnancy test will be conducted prior to enrollment if required by Institutional Review Board (IRB), Regional Ethics Board (REB), local Ethics Committee (EC) or competent authority.
研究组 & 干预措施
Experimental
Experimental
Subjects randomized to the experimental arm will have their heart unloaded for 30 minutes on the Impella CP® device prior to PCI.
Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.
干预措施: Impella CP® placement prior to reperfusion with Primary PCI (Device)
Control
No Intervention
Primary PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.
结局指标
主要结局
Infarct Size
时间窗: 3-5 days post-procedure
Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR) imaging
次要结局
- Key Powered Composite Secondary Efficacy Endpoint:(12 months after the randomization of the last enrolled subject)
- Key Secondary Safety Endpoint(30 days)
- Powered Secondary Endpoint:(3-5 days)
- Powered Secondary Endpoints:(3-5 days)
- Powered Secondary Endpoints:(6 months)
- Powered Secondary Endpoints:(90 days)
研究者
研究点 (63)
Loading locations...
相似试验
终止
不适用
The RECOVER IV TrialST-segment Elevation Myocardial Infarction (STEMI)Cardiogenic ShockNCT05506449Abiomed Inc.4
已完成
不适用
Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility StudySTEMINCT03000270Abiomed Inc.50
已完成
不适用
ECLS Versus IMPELLA™ as Bridge to LVAD (ECI-BLAD)Cardiogenic ShockEnd-stage Heart FailureNCT04480151University Hospital, Bordeaux92
招募中
不适用
The ECMOCYP (cytochromes P450 Activity) StudyECMOTemporary Mechanical Circulatory SupportCardiogenic ShockNCT06662084University Hospital, Geneva46
已完成
不适用
Efficacy of a New Technique -"IN-REC-SUR-E"- in Preterm Neonates With RDSRespiratory Distress SyndromeHyaline Membrane DiseaseNCT02482766Catholic University of the Sacred Heart206