ST Elevation (STEMI) Myocardial Infarction of Anterior Wall Clinical Trial
— DTU-STEMIOfficial title:
Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
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.
| Status | Recruiting |
| Enrollment | 668 |
| Est. completion date | October 2030 |
| Est. primary completion date | November 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Calgary | Calgary | Alberta |
| Canada | University of Alberta | Edmonton | Alberta |
| Canada | Hamilton Health Science | Hamilton | Ontario |
| Canada | McGill University Health Center | Montreal | Quebec |
| Canada | Montreal Heart Institute | Montreal | Quebec |
| Canada | University of Ottawa Heart Institue | Ottawa | Ontario |
| Canada | Sunnybrook Health Science Center | Toronto | Ontario |
| Canada | Toronto General Hospital | Toronto | Ontario |
| Germany | Heart Center Dresden | Dresden | Saxony |
| Germany | University Hospital Düsseldorf | Dusseldorf | NRW |
| Germany | West German Heart Center Essen | Essen | NRW |
| Germany | Universitätsklinikum Jena | Jena | |
| Germany | University Hospital of Marburg | Marburg | |
| Germany | Stadtische Kliniken Neuss- Lukaskrankenhaus | Neuss | North Rhine-Westphalia |
| Germany | Krankenhaus der Barmherzigen Brüder Trier | Trier | RP |
| Germany | University Hospital Würzburg | Würzburg | Bavaria |
| Germany | Heinrich-Braun-Klinikum Zwickau | Zwickau | |
| Italy | Ospedale Policlinico San Martino | Genova | Liguria |
| Italy | San Raffaele | Milan | Lombardy |
| Italy | ASST Grande Ospedale Metropolitano Niguarda | Milano | |
| Italy | Humanitas Clinical & Research Hospital | Rozzano | |
| Italy | Azienda Ospedaliera Universitaria Integrata Di Verona | Verona | Veneto |
| Netherlands | Erasmus MC Rotterdam | Rotterdam | South Holland |
| Switzerland | Bern University Hospital | Bern | |
| Switzerland | Luzerner Kantonsspital | Lucerne | |
| United Kingdom | Harefield Hospital | Harefield | |
| United States | New Mexico Heart Institute | Albuquerque | New Mexico |
| United States | Presbyterian Heart Research Group | Albuquerque | New Mexico |
| United States | Northside Hospital | Atlanta | Georgia |
| United States | University Health, Inc | Augusta | Georgia |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Mass General Hospital | Boston | Massachusetts |
| United States | Tufts Medical Center | Boston | Massachusetts |
| United States | University of Buffalo Hospital | Buffalo | New York |
| United States | Charleston Area Medical Center | Charleston | West Virginia |
| United States | BayCare Cardiology - Morton Plant Hospital | Clearwater | Florida |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | Prisma Health | Columbia | South Carolina |
| United States | Concord Hospital | Concord | New Hampshire |
| United States | Metropolitan Heart and Vascular Institue | Coon Rapids | Minnesota |
| United States | Emanate Health Intercommunity Hospital / Valley Clinical Trials, Inc. | Covina | California |
| United States | Ascension St. John Hospital | Detroit | Michigan |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | UPMC Hamot | Erie | Pennsylvania |
| United States | North Shore University Health System | Evanston | Illinois |
| United States | Providence Regional Medical Center - Everett | Everett | Washington |
| United States | Spectrum | Grand Rapids | Michigan |
| United States | Greenville Health System | Greenville | South Carolina |
| United States | Hackensack Medical Center | Hackensack | New Jersey |
| United States | Hartford Health Care | Hartford | Connecticut |
| United States | The University of Texas Health Science Center at Houston | Houston | Texas |
| United States | Baptist Health Research Institute | Jacksonville | Florida |
| United States | Kettering Medical Center | Kettering | Ohio |
| United States | Ballad Health - Wellmont CVA Institute | Kingsport | Tennessee |
| United States | University of Tennessee Medical Center | Knoxville | Tennessee |
| United States | St. Anthony Hospital | Lakewood | Colorado |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Northwell Health | Manhasset | New York |
| United States | Wellstar/Kennestone Hospital | Marietta | Georgia |
| United States | Hackensack Meridian Mountainside Medical Center | Montclair | New Jersey |
| United States | West Virginia University Hospital | Morgantown | West Virginia |
| United States | Midwest Cardiovascular Institute | Naperville | Illinois |
| United States | Centennial Medical Center | Nashville | Tennessee |
| United States | Jersey Shore University Medical Center | Neptune | New Jersey |
| United States | Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey |
| United States | NYU School of Medicine | New York | New York |
| United States | Christiana Care Health Services | Newark | Delaware |
| United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
| United States | Advocate Edward Hospital | Oakbrook Terrace | Illinois |
| United States | OSF Saint Francis | Peoria | Illinois |
| United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
| United States | UPMC Presbyterian | Pittsburgh | Pennsylvania |
| United States | Riverside Community Hospital | Riverside | California |
| United States | Methodist Hospital | San Antonio | Texas |
| United States | HonorHealth Research Institute | Scottsdale | Arizona |
| United States | Southern Illinois University School of Medicine | Springfield | Illinois |
| United States | Stony Brook Medicine | Stony Brook | New York |
| United States | Tallahasse Research Institute | Tallahassee | Florida |
| United States | AdventHealth - Tampa | Tampa | Florida |
| United States | The University of Arizona | Tucson | Arizona |
| United States | Oklahoma Heart Institute | Tulsa | Oklahoma |
| United States | George Washington University | Washington | District of Columbia |
| United States | Mercy Iowa Heart | West Des Moines | Iowa |
| Lead Sponsor | Collaborator |
|---|---|
| Abiomed Inc. |
United States, Canada, Germany, Italy, Netherlands, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Infarct Size | Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR) imaging | 3-5 days post-procedure | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02071602 -
CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function
|
Phase 1 |