Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial

Conditions
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ST Elevation (STEMI) Myocardial Infarction of Anterior Wall

Intervention / Treatment
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* Device: Impella CP® placement prior to reperfusion with Primary PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 hospital between 1 - 6 hours of ischemic pain onset Patient indicated for Primary PCI Patient or the patient's Legally Authorized Representative (where applicable) has signed Informed Consent Exclusion Criteria: 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, 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, members of the armed forces, and persons kept in detention].

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: A prospective, multicenter, randomized, controlled open-label two-arm trial with an adaptive design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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. | Device: Impella CP® placement prior to reperfusion with Primary PCI<br>* Subjects randomized to the experimental arm, will undergo Impella CP® placement through a femoral arterial sheath and the Impella device will be activated to unload the left ventricle.<br>|
| No Intervention: Control<br>Primary PCI. Each site is required to have one roll-in per arm to test the study protocol before beginning enrollment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct Size | Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR) imaging | 3-5 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct Size, as a percent of Left Ventricular Mass | Efficacy- Composite clinical secondary endpoint, Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic. | 3-5 days | 
| Impella CP® related Major Bleeding and Major Vascular complications | Efficacy (Cardiogenic Shock)- Composite clinical secondary endpoint. Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic. Secondary Safety (Major Bleeding and Vascular Complications); with pre-specified performance goals. | 30 Days | 
| Cardiogenic Shock, CV mortality, Heart Failure, LVAD or Heart Transplant and ICD or CRT Placement | Efficacy- Composite clinical secondary endpoint. Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior STEMI, ST-Elevated MI, Cardiac Unloading