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 States, Canada, Germany527 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 range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether using a device to unload the heart before opening the blocked artery — rather than opening it right away — could reduce the size of a heart attack; is that an approach my doctor thinks could be relevant to my specific situation, and what are the known risks of delaying reperfusion?
2Since this trial is listed as 'active not recruiting,' does that mean I can no longer join it, and are there similar studies still enrolling that my doctor could point me toward?
3The trial is measuring infarct size — meaning how much heart muscle is damaged — as its main outcome, but what does my doctor think that would actually mean for my long-term heart function and quality of life if the approach worked?
4This trial doesn't have a standard phase label, which can mean it's a more exploratory or device-focused study; how does that affect what we already know about the safety and benefit of this 'unload first, then open' strategy compared to the standard immediate stenting I might receive?
5Would my doctor recommend I pursue standard primary PCI right away given my anterior wall STEMI, and under what circumstances might a strategy like the one in this trial ever be worth considering for someone in my position?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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