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Mechanical Circulatory Support for Heart Attack (DTU-STEMI Trial)
DTU-STEMI Trial Summary
This trial will test whether using a temporary circulatory assist device for 30 minutes prior to a catheterization procedure can reduce heart damage from a heart attack.
DTU-STEMI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDTU-STEMI Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DTU-STEMI Trial Design
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Who is running the clinical trial?
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- I might have an infection that is affecting my whole body.I have not had a stroke, brain bleed, or lasting brain injury in the last 3 months.I am on dialysis.I am currently taking blood thinners.I had a cardiac arrest that was either not seen, required long CPR, or affected my brain function.I have had a serious heart complication such as a tear in the heart wall or valve issue.You have a known allergy or bad reaction to heparin, pork, pork products, or contrast media.I am between 18 and 85 years old.I do not have a bleeding disorder, recent serious bleeding, or refuse blood transfusions.I cannot have the Impella device due to issues with my blood vessels.I have had liver problems before any catheter procedures.I can safely undergo an MRI and use gadolinium.You cannot receive a drug-coated stent for medical reasons.I have had a heart attack affecting the lower part of my heart or suspect heart failure.I have COPD and use oxygen at home or take chronic steroids.I arrived at the hospital within 1 to 6 hours after starting to feel chest pain.I have had heart bypass surgery or a procedure to open my heart's arteries.You have a specific heart condition called left bundle branch block.You are part of a group that may not be able to fully understand or communicate about the study, such as people with mental disabilities, those living in nursing homes, children, impoverished individuals, homeless individuals, nomads, refugees, and those who cannot give informed consent.I do not have any health issues that could interfere with the study or pose a risk to me.I have had a heart attack before.I had a severe heart attack affecting the front part of my heart, confirmed by tests.I have had surgery on my aortic valve or a TAVR procedure.I have had a heart attack for the first time.I was moved from another hospital after a heart procedure was tried.I have a history of heart failure or was hospitalized for it within the last year.I am recommended to undergo a procedure to open blocked arteries.I have had a severe heart condition requiring medication or devices to maintain my blood pressure.I have not received clot-dissolving drugs in the last 24 hours.I have a severe narrowing of the main heart valve.
- Group 1: Control
- Group 2: Experimental
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are patients of all ages eligible for this research?
"The age range for this study is 18 to 80 years old."
At how many institutions is this research being conducted?
"Enrollment for this clinical trial is currently taking place at University of Buffalo Hospital, The University of Texas Health Science Center at Houston, Sentara Norfolk General Hospital and an additional 46 medical facilities."
How many guinea pigs are a part of this experiment?
"That is correct. The study, which began recruiting on December 12th 2019, is still looking for 668 participants at 46 sites around the world according to the latest update from July 14th 2022."
Which patients would be a good match for this clinical trial?
"668 individuals aged 18-80 who have had an infarction are being recruited for this study. In order to participate, patients must meet the following age and presentation criteria: 18-80 years old and hospital arrival 1-5 hours after onset of ischemic pain."
Are people with the necessary qualifications currently being sought for this research project?
"That is correct. The clinical trial, which began recruitment on December 12th 2019, is still ongoing according to the information available on clinicaltrials.gov. There are currently 668 participants enrolled at 46 sites around the world."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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