Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial (NCT03947619) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
United States527 participantsStarted 2019-12-12
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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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