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Temporary Circulatory Assist Device

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

N/A

Waitlist Available

Led By William O'Neill, 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

Must not have

Suspected systemic active infection

History of stroke/TIA within the prior 3 months, any history of Intracranial Hemorrhage or any permanent neurological deficit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I might have an infection that is affecting my whole body.

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I have not had a stroke, brain bleed, or lasting brain injury in the last 3 months.

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I am on dialysis.

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I am currently taking blood thinners.

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I had a cardiac arrest that was either not seen, required long CPR, or affected my brain function.

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I have had a serious heart complication such as a tear in the heart wall or valve issue.

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I do not have a bleeding disorder, recent serious bleeding, or refuse blood transfusions.

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I cannot have the Impella device due to issues with my blood vessels.

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I have had liver problems before any catheter procedures.

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I can safely undergo an MRI and use gadolinium.

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I have had a heart attack affecting the lower part of my heart or suspect heart failure.

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I have COPD and use oxygen at home or take chronic steroids.

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I have had heart bypass surgery or a procedure to open my heart's arteries.

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I have had a heart attack before.

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I have had surgery on my aortic valve or a TAVR procedure.

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I was moved from another hospital after a heart procedure was tried.

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I have had a severe heart condition requiring medication or devices to maintain my blood pressure.

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I have not received clot-dissolving drugs in the last 24 hours.

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I have a severe narrowing of the main heart valve.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Infarct Size

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 24Eligibility criteria met