Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
Overview
- Phase
- N/A
- Intervention
- Impella CP® placement prior to reperfusion with Primary PCI
- Conditions
- ST Elevation (STEMI) Myocardial Infarction of Anterior Wall
- Sponsor
- Abiomed Inc.
- Enrollment
- 527
- Locations
- 63
- Primary Endpoint
- Infarct Size
- Status
- Active, Not Recruiting
- Last Updated
- last month
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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 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
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
Arms & Interventions
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.
Intervention: Impella CP® placement prior to reperfusion with Primary PCI
Control
Primary PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.
Outcomes
Primary Outcomes
Infarct Size
Time Frame: 3-5 days post-procedure
Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR) imaging
Secondary Outcomes
- 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)