Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial (DTU-STEMI)
ST Elevation (STEMI) Myocardial Infarction of Anterior Wall
About this trial
This is an interventional treatment trial for ST Elevation (STEMI) Myocardial Infarction of Anterior Wall focused on measuring Anterior STEMI, ST-Elevated MI, Cardiac Unloading
Eligibility Criteria
Inclusion Criteria:
- Age 18-80 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 - 5 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 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
- 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].
Sites / Locations
- University of Alabama at BirminghamRecruiting
- HonorHealth Research InstituteRecruiting
- The University of ArizonaRecruiting
- Emanate Health Intercommunity Hospital / Valley Clinical Trials, Inc.
- Cedars-Sinai Medical Center
- Riverside Community HospitalRecruiting
- St. Anthony HospitalRecruiting
- Hartford Health CareRecruiting
- Christiana Care Health ServicesRecruiting
- George Washington UniversityRecruiting
- BayCare Cardiology - Morton Plant HospitalRecruiting
- Baptist Health Research InstituteRecruiting
- Tallahasse Research InstituteRecruiting
- AdventHealth - TampaRecruiting
- Northside Hospital
- University Health, Inc
- Wellstar/Kennestone Hospital
- North Shore University Health SystemRecruiting
- Midwest Cardiovascular Institute
- Advocate Edward Hospital
- Southern Illinois University School of Medicine
- Mercy Iowa HeartRecruiting
- Tufts Medical CenterRecruiting
- Mass General Hospital
- Henry Ford HospitalRecruiting
- Ascension St. John Hospital
- SpectrumRecruiting
- Metropolitan Heart and Vascular Institue
- Concord Hospital
- Hackensack Medical CenterRecruiting
- Jersey Shore University Medical CenterRecruiting
- Rutgers Robert Wood Johnson Medical SchoolRecruiting
- New Mexico Heart InstituteRecruiting
- Presbyterian Heart Research GroupRecruiting
- University of Buffalo HospitalRecruiting
- Northwell HealthRecruiting
- NYU School of MedicineRecruiting
- Stony Brook Medicine
- University Hospitals Cleveland Medical CenterRecruiting
- Kettering Medical CenterRecruiting
- Oklahoma Heart InstituteRecruiting
- UPMC HamotRecruiting
- Allegheny General Hospital
- UPMC PresbyterianRecruiting
- Prisma HealthRecruiting
- Greenville Health SystemRecruiting
- Ballad Health - Wellmont CVA InstituteRecruiting
- University of Tennessee Medical CenterRecruiting
- Centennial Medical Center
- The University of Texas Health Science Center at HoustonRecruiting
- Methodist HospitalRecruiting
- Sentara Norfolk General HospitalRecruiting
- Providence Regional Medical Center - Everett
- Charleston Area Medical Center
- West Virginia University Hospital
- University Hospital WürzburgRecruiting
- Stadtische Kliniken Neuss- LukaskrankenhausRecruiting
- University Hospital DüsseldorfRecruiting
- West German Heart Center EssenRecruiting
- Krankenhaus der Barmherzigen Brüder TrierRecruiting
- Heart Center DresdenRecruiting
- University Hospital of MarburgRecruiting
- Heinrich-Braun-Klinikum ZwickauRecruiting
- Ospedale Policlinico San Martino
- San RaffaeleRecruiting
- Azienda Ospedaliera Universitaria Integrata Di Verona
- ASST Grande Ospedale Metropolitano Niguarda
- Humanitas Clinical & Research Hospital
- Erasmus MC RotterdamRecruiting
- Bern University Hospital
- Luzerner KantonsspitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Experimental
Control
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.
Primary PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.