Active, not recruiting
Not applicable
Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
Condition(s) studied
ST Elevation (STEMI) Myocardial Infarction of Anterior Wall
Investigational drug(s) / intervention(s)
Impella CP® placement prior to reperfusion with Primary PCI
Impella CP® placement prior to reperfusion with Primary PCI: 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.
Study 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.
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.
Primary outcome measure(s)
- Infarct Size — 3-5 days post-procedure
Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR) imaging
Trial sites (63)
| Facility | City | Region | Status |
| University of Alabama at Birmingham |
Birmingham |
Alabama |
|
| HonorHealth Research Institute |
Scottsdale |
Arizona |
|
| The University of Arizona |
Tucson |
Arizona |
|
| Emanate Health Intercommunity Hospital / Valley Clinical Trials, Inc. |
Covina |
California |
|
| Riverside Community Hospital |
Riverside |
California |
|
| St. Anthony Hospital |
Lakewood |
Colorado |
|
| Hartford Health Care |
Hartford |
Connecticut |
|
| Christiana Care Health Services |
Newark |
Delaware |
|
| George Washington University |
Washington D.C. |
District of Columbia |
|
| BayCare Cardiology - Morton Plant Hospital |
Clearwater |
Florida |
|
| Baptist Health Research Institute |
Jacksonville |
Florida |
|
| Tallahasse Research Institute |
Tallahassee |
Florida |
|
| AdventHealth - Tampa |
Tampa |
Florida |
|
| Northside Hospital |
Atlanta |
Georgia |
|
| Wellstar/Kennestone Hospital |
Marietta |
Georgia |
|
| North Shore University Health System |
Evanston |
Illinois |
|
| Midwest Cardiovascular Institute |
Naperville |
Illinois |
|
| OSF Saint Francis |
Peoria |
Illinois |
|
| Southern Illinois University School of Medicine |
Springfield |
Illinois |
|
| Mercy Iowa Heart |
West Des Moines |
Iowa |
|
| Tufts Medical Center |
Boston |
Massachusetts |
|
| Henry Ford Hospital |
Detroit |
Michigan |
|
| Ascension St. John Hospital |
Detroit |
Michigan |
|
| Spectrum |
Grand Rapids |
Michigan |
|
| Hackensack Medical Center |
Hackensack |
New Jersey |
|
| Hackensack Meridian Mountainside Medical Center |
Montclair |
New Jersey |
|
| Jersey Shore University Medical Center |
Neptune City |
New Jersey |
|
| Rutgers Robert Wood Johnson Medical School |
New Brunswick |
New Jersey |
|
| New Mexico Heart Institute |
Albuquerque |
New Mexico |
|
| Presbyterian Heart Research Group |
Albuquerque |
New Mexico |
|
| University of Buffalo Hospital |
Buffalo |
New York |
|
| Northwell Health |
Manhasset |
New York |
|
| NYU School of Medicine |
New York |
New York |
|
| University Hospitals Cleveland Medical Center |
Cleveland |
Ohio |
|
| Kettering Medical Center |
Kettering |
Ohio |
|
| Oklahoma Heart Institute |
Tulsa |
Oklahoma |
|
| UPMC Presbyterian |
Pittsburgh |
Pennsylvania |
|
| Prisma Health |
Columbia |
South Carolina |
|
| Greenville Health System |
Greenville |
South Carolina |
|
| Ballad Health - Wellmont CVA Institute |
Kingsport |
Tennessee |
|
+ 23 more sites — see the full list on the official registry below.
More Abiomed Inc. trials in the USA