Active not recruitingNAINTERVENTIONAL

Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial

This research study is investigating a new approach to treating a severe type of heart attack called an anterior ST-Elevation Myocardial Infarction (STEMI). We want to find out if using a temporary heart pump, called the Impella CP® System, for about 30 minutes before the usual heart procedure (Primary PCI) can help reduce the amount of damage to the heart muscle. The standard treatment for this type of heart attack is to open the blocked artery as quickly as possible. This study aims to see if adding the Impella pump beforehand offers extra protection to the heart. We are comparing this new method to the current standard care to see if it's both safe and more effective at limiting heart damage and preventing future heart-related problems.

At a glance

Status

Active not recruiting

Phase

Sponsor

Abiomed Inc.

Enrolment target

527

Start

12 Dec 2019

Estimated completion

01 Oct 2030

ST Elevation (STEMI) Myocardial Infarction of Anterior Wall

What is this study about?

When someone has a heart attack, it's usually because an artery supplying blood to the heart gets blocked. This means the heart muscle doesn't get enough oxygen, leading to damage. A very serious type of heart attack is called an anterior ST-Elevation Myocardial Infarction, or anterior STEMI, which affects the front of the heart and can cause significant damage.

The usual treatment for this kind of heart attack is a procedure called Primary PCI (Percutaneous Coronary Intervention). This is when doctors use a small tube, or catheter, to reach the blocked artery and open it up, usually with a balloon and a stent, to restore blood flow. The faster this is done, the better for the heart.

This study is looking at a different approach. Before performing the usual Primary PCI, doctors would temporarily place a small pump called the Impella CP® System into the heart for about 30 minutes. This pump helps the heart work less hard by taking some of the strain off it. The idea is that by 'unloading' the heart for a short period before restoring blood flow, we might be able to protect the heart muscle more and reduce the overall damage from the heart attack. We are comparing this new method to the current standard treatment to see if it's a better way to care for patients and help prevent long-term heart problems.

Key takeaways

The study explores a new way to treat severe heart attacks.
It uses a temporary heart pump (Impella CP®) before standard treatment.
The goal is to reduce heart damage from the heart attack.
It aims to see if this new approach is safer and more effective than current care.
Participation involves being randomly assigned to one of two treatment groups.

Who may be eligible?

This study is looking for people aged between 18 and 85 years old who are having their very first heart attack. Specifically, we're interested in those who have had a severe heart attack affecting the front of the heart, known as an anterior STEMI.

To be considered for the study, you would need to arrive at the hospital and be seen for treatment within 1 to 6 hours of your chest pain starting. You must also be suitable for the standard heart procedure called Primary PCI. Importantly, you or a legal representative would need to understand and agree to take part by signing a consent form.

There are also some reasons why you wouldn't be able to join the study. For example, if you've already had a heart procedure for this heart attack at another hospital, or if you had a long period of CPR or changes in your mental state after a cardiac arrest. Other reasons include having very low blood pressure or needing certain medications to keep your blood pressure up (cardiogenic shock), having other serious heart conditions like specific valve problems, being pregnant, having a serious infection, or experiencing other severe health issues affecting your liver or kidneys. Also, if there's any reason you can't have the Impella device safely placed, you wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 85 years old?
Is this your first heart attack?
Did your chest pain start within the last 1 to 6 hours?
Are you having a severe heart attack affecting the front of your heart (anterior STEMI)?

Answer every question to see your result.

What does participation involve?

This study focuses on your treatment during and immediately after a severe heart attack. If you agree to take part, you would either receive the standard heart procedure (Primary PCI) or the new approach which involves placing the Impella pump for 30 minutes before your Primary PCI. The specific details of your hospital stay and follow-up care would be similar to what is typical after a heart attack. There would be assessments during your hospital stay to check your heart's recovery, and doctors would continue to monitor your health. The total duration of your participation, including follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. For this study, a potential benefit is that the new treatment strategy might lead to less damage to your heart muscle, which could improve your long-term heart health compared to the standard treatment. However, inserting the Impella pump carries its own risks, similar to other heart procedures, such as bleeding, infection, or damage to blood vessels. We will carefully monitor you for any potential problems. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting the quality of your medical care.

Locations (63)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
HonorHealth Research Institute
Verified postcode
Scottsdale, United States
The University of Arizona
Verified postcode
Tucson, United States
Emanate Health Intercommunity Hospital / Valley Clinical Trials, Inc.
Verified postcode
Covina, United States
Riverside Community Hospital
Verified postcode
Riverside, United States
St. Anthony Hospital
Verified postcode
Lakewood, United States
Hartford Health Care
Verified postcode
Hartford, United States
Christiana Care Health Services
Verified postcode
Newark, United States
George Washington University
Verified postcode
Washington D.C., United States
BayCare Cardiology - Morton Plant Hospital
Verified postcode
Clearwater, United States
Baptist Health Research Institute
Verified postcode
Jacksonville, United States
Tallahasse Research Institute
Verified postcode
Tallahassee, United States

Common questions

What is an anterior STEMI?

It's a serious type of heart attack where a major artery supplying the front of your heart is completely blocked.

What is Primary PCI?

It's a common emergency procedure used to open blocked heart arteries during a heart attack, usually with a balloon and a small tube called a stent.

What is the Impella CP® System?

It's a small temporary pump that can be placed in your heart to help it pump blood while it's recovering, reducing its workload.

Will I definitely get the new treatment?

No, participants are usually randomly assigned to either receive the new treatment or the standard treatment, so it's a 50/50 chance.

How long will the Impella pump be in my heart?

If you receive the Impella pump as part of this study, it would typically be placed for about 30 minutes before your main heart procedure.