Clinical trial NCT03947619: Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
Official title: Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ST Elevation (STEMI) Myocardial Infarction of Anterior Wall
Keywords: Anterior STEMI
ST-Elevated MI
Cardiac Unloading
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-13
Enrollment: 527
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A prospective, multicenter, randomized, controlled open-label two-arm trial with an adaptive design
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-85 years
2. First myocardial infarction
3. 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
4. Patient presents to the enrolling hospital where the index procedure will be performed between 1 - 6 hours after onset of continuous ischemic pain
5. Patient indicated for Primary PCI
6. Patient or the patient's Legally Authorized Representative (where applicable) has signed Informed Consent

Exclusion Criteria:

1. Patient transferred from an outside hospital where invasive coronary procedure was attempted (including diagnostic catheterization)
2. 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
3. Administration of fibrinolytic therapy within 24 hours prior to enrollment
4. 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
5. Inferior STEMI or suspected right ventricular failure
6. Any contraindication or inability to place the Impella, including peripheral vascular disease, tortuous vascular anatomy, femoral bruits or absent pedal pulses
7. Severe aortic stenosis
8. Acute cardiac mechanical complication: LV free wall rupture OR Interventricular septum rupture OR Acute mitral regurgitation
9. Suspected or known pregnancy
10. Suspected systemic active infection
11. History or known hepatic insufficiency prior to catheterization
12. On renal replacement therapy
13. COPD with home oxygen therapy or on chronic steroid therapy
14. Known or evidence of prior myocardial infarction, including pathologic Q waves in non-anterior leads
15. Prior CABG or LAD PCI
16. History of heart failure (documented history of EF \<40% or documented hospitalization for HF within one (1) year prior to screening)
17. Prior aortic valve surgery or TAVR
18. Left bundle branch block (new or old)
19. History of stroke/TIA within the prior 3 months, any history of Intracranial Hemorrhage or any permanent neurological deficit
20. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent GU or GI bleed, or will refuse blood transfusions
21. Patient on systemic anticoagulation pre-procedure (including factor Xa inhibitors, thrombin inhibitors, warfarin)

    Known contraindication to:
22. Undergoing MRI or use of gadolinium, \[CrCl\<30 ml/min, non-compatible implant, claustrophobia\]
23. Heparin, pork, pork products or contrast media
24. Receiving a drug-eluting stent
25. 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.
26. 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.
27. 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.
28. 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.

Primary outcomes:
measure: Infarct Size
timeFrame: 3-5 days post-procedure
Secondary outcomes:
measure: Infarct Size, as a percent of Left Ventricular Mass
timeFrame: 3-5 days
measure: Impella CP® related Major Bleeding and Major Vascular complications
timeFrame: 30 Days
measure: Cardiogenic Shock, CV mortality, Heart Failure, LVAD or Heart Transplant and ICD or CRT Placement
timeFrame: 12 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona
state: Arizona
city: Covina
country: United States
facility: Emanate Health Intercommunity Hospital / Valley Clinical Trials, Inc.
state: California
city: Riverside
country: United States
facility: Riverside Community Hospital
state: California
city: Lakewood
country: United States
facility: St. Anthony Hospital
state: Colorado
city: Hartford
country: United States
facility: Hartford Health Care
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Clearwater
country: United States
facility: BayCare Cardiology - Morton Plant Hospital
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health Research Institute
state: Florida
city: Tallahassee
country: United States
facility: Tallahasse Research Institute
state: Florida
city: Tampa
country: United States
facility: AdventHealth - Tampa
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Marietta
country: United States
facility: Wellstar/Kennestone Hospital
state: Georgia
city: Evanston
country: United States
facility: North Shore University Health System
state: Illinois
city: Naperville
country: United States
facility: Midwest Cardiovascular Institute
state: Illinois
city: Peoria
country: United States
facility: OSF Saint Francis
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: West Des Moines
country: United States
facility: Mercy Iowa Heart
state: Iowa
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum
state: Michigan
city: Hackensack
country: United States
facility: Hackensack Medical Center
state: New Jersey
city: Montclair
country: United States
facility: Hackensack Meridian Mountainside Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: New Brunswick,
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: Albuquerque
country: United States
facility: Presbyterian Heart Research Group
state: New Mexico
city: Buffalo
country: United States
facility: University of Buffalo Hospital
state: New York
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Columbia
country: United States
facility: Prisma Health
state: South Carolina
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Kingsport
country: United States
facility: Ballad Health - Wellmont CVA Institute
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton Health Science
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institue
state: Ontario
city: Würzburg
country: Germany
facility: University Hospital Würzburg
state: Bavaria
city: Dusseldorf
country: Germany
facility: University Hospital Düsseldorf
state: NRW
city: Essen
country: Germany
facility: West German Heart Center Essen
state: NRW
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier
state: RP
city: Dresden
country: Germany
facility: Heart Center Dresden
state: Saxony
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Marburg
country: Germany
facility: University Hospital of Marburg
city: Zwickau
country: Germany
facility: Heinrich-Braun-Klinikum Zwickau
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
state: Liguria
city: Milan
country: Italy
facility: San Raffaele
state: Lombardy
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Di Verona
state: Veneto
city: Rozzano
country: Italy
facility: Humanitas Clinical &amp; Research Hospital
city: Lucerne
country: Switzerland
facility: Luzerner Kantonsspital
city: Harefield
country: United Kingdom
facility: Harefield Hospital
Study officials:
affiliation: Henry Ford Hospital
name: William O'Neill, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Center Dresden
name: Norman Mangner, Prof. Dr. med. habil.
role: PRINCIPAL_INVESTIGATOR
References: