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Temporary Circulatory Assist Device

Mechanical Circulatory Support for Heart Attack (DTU-STEMI Trial)

N/A
Recruiting
Led By Navin Kapur, MD
Research Sponsored by Abiomed Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-85 years
Patient presents to the hospital between 1 - 6 hours of ischemic pain onset
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

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.

Who is the study for?
This trial is for adults aged 18-85 who are experiencing their first heart attack and can get to the hospital within 1-6 hours of chest pain. They must be suitable for a procedure called Primary PCI and agree to participate by signing consent forms. People with severe heart valve issues, liver or kidney problems, certain lung conditions, or those in other studies can't join.Check my eligibility
What is being tested?
The study tests if using the Impella CP device before reperfusion therapy (Primary PCI) can reduce heart damage during a heart attack compared to standard immediate treatment. Participants will have this device placed for 30 minutes prior to their catheterization procedure.See study design
What are the potential side effects?
Potential side effects may include complications from placing the Impella CP device such as bleeding, blood vessel damage, infection risk at insertion site, irregular heartbeat, or allergic reactions related to the device materials.

DTU-STEMI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 85 years old.
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I arrived at the hospital within 1 to 6 hours after starting to feel chest pain.
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I had a severe heart attack affecting the front part of my heart, confirmed by tests.
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I have had a heart attack for the first time.
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I am recommended to undergo a procedure to open blocked arteries.

DTU-STEMI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Infarct Size
Secondary outcome measures
Cardiogenic Shock, CV mortality, Heart Failure, LVAD or Heart Transplant and ICD or CRT Placement
Impella CP® related Major Bleeding and Major Vascular complications
Infarct Size, as a percent of Left Ventricular Mass

DTU-STEMI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
Subjects randomized to the experimental arm will have their heart unloaded for 30 minutes on the Impella CP® device prior to PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.
Group II: ControlActive Control1 Intervention
Primary PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.

Find a Location

Who is running the clinical trial?

Abiomed Inc.Lead Sponsor
41 Previous Clinical Trials
33,887 Total Patients Enrolled
7 Trials studying Myocardial Infarction
1,168 Patients Enrolled for Myocardial Infarction
Navin Kapur, MDPrincipal InvestigatorTufts University Medical Center
2 Previous Clinical Trials
575 Total Patients Enrolled
1 Trials studying Myocardial Infarction
560 Patients Enrolled for Myocardial Infarction
William O'Neill, MDPrincipal InvestigatorHenry Ford Hospital
6 Previous Clinical Trials
12,194 Total Patients Enrolled
1 Trials studying Myocardial Infarction
560 Patients Enrolled for Myocardial Infarction

Media Library

IMPELLA® CP System (Temporary Circulatory Assist Device) Clinical Trial Eligibility Overview. Trial Name: NCT03947619 — N/A
Myocardial Infarction Research Study Groups: Control, Experimental
Myocardial Infarction Clinical Trial 2023: IMPELLA® CP System Highlights & Side Effects. Trial Name: NCT03947619 — N/A
IMPELLA® CP System (Temporary Circulatory Assist Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03947619 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients of all ages eligible for this research?

"The age range for this study is 18 to 80 years old."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What site did they apply to?
Ballad Health - Wellmont CVA Institute
What portion of applicants met pre-screening criteria?
Met criteria
~81 spots leftby Nov 2024