Active not recruitingNAINTERVENTIONAL

Remote Ischemic Conditioning With Local Ischemic Postconditioning in High-Risk ST-elevation Myocardial Infarction

This study, called RIP-HIGH, is for people who have had a severe type of heart attack known as a STEMI and are considered high-risk. When you have a heart attack, doctors quickly work to unblock the affected artery. While this treatment saves lives, sometimes the process of restoring blood flow can cause further damage to the heart muscle. This study is testing if combining two gentle methods, called 'remote ischemic conditioning' (RIC) and 'local ischemic postconditioning' (PostC), can help protect the heart from this extra damage. These methods involve briefly restricting and then restoring blood flow to an arm or leg (RIC) or to the heart itself during the unblocking procedure (PostC). Researchers want to see if adding these techniques to the usual treatment improves how patients recover compared to standard care alone.

At a glance

Status

Active not recruiting

Phase

Sponsor

Helios Health Institute GmbH

Enrolment target

250

Start

05 Jul 2021

Estimated completion

01 Jul 2030

ST Elevation Myocardial Infarction

What is this study about?

When someone has a serious heart attack, called an ST-elevation myocardial infarction (STEMI), it means blood flow to a part of the heart is completely blocked. Doctors act quickly to clear this blockage, usually by a procedure called an angioplasty, to restore blood flow and save heart muscle.

While restoring blood flow is vital, sometimes the process itself can cause a bit more damage to the heart. This is known as "reperfusion injury." Imagine a dry sponge that you suddenly drench – sometimes it can break apart. Doctors are always looking for ways to protect the heart even further during this crucial time.

This study is investigating two gentle techniques called 'ischemic conditioning.' One is 'remote ischemic conditioning' (RIC), which involves briefly inflating and deflating a blood pressure cuff on an arm or leg. The other is 'local ischemic postconditioning' (PostC), which involves briefly and repeatedly blocking and unblocking the heart's artery during the angioplasty. The idea is that these short, harmless periods of restricted blood flow might "pre-condition" or "post-condition" the heart, making it more resilient to the main blood flow restoration. Researchers want to see if combining these two techniques with the standard angioplasty improves how well high-risk STEMI patients recover.

Key takeaways

This study explores new ways to protect your heart during a severe heart attack.
It combines two gentle techniques (ischemic conditioning) with standard heart attack treatment.
The aim is to reduce heart damage and improve recovery for high-risk patients.
You would receive either the new combined treatment or standard care, decided by chance.
Participation is voluntary, and your doctor can answer all your questions.

Who may be eligible?

To be part of this study, you would need to have had a specific type of major heart attack (STEMI) that appeared less than 12 hours ago. Your doctors would have seen certain changes on your heart tracing (ECG), or you might have been diagnosed with a new heart rhythm problem like a bundle branch block. The study is particularly looking for people whose heart attack has caused some significant symptoms, such as being very breathless or needing medications to help with fluid build-up, which doctors call Killip class 2 or higher.

You would not be able to join if your heart attack was less severe (Killip class 1) or if you've already had a different heart attack treatment called 'fibrinolysis.' Also, if you have certain conditions that would make using the 'conditioning' treatments difficult (like arm weakness or where you have a special connection made for dialysis), or if you are pregnant, under 18, have another serious illness expected to shorten your life, or are already in another research study, you wouldn't be able to take part.

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.

Have I had a major heart attack (STEMI) recently, within the last 12 hours?
Am I experiencing significant symptoms like breathlessness or fluid retention due to my heart attack?
Am I at least 18 years old and not pregnant?
Do I have any serious health problems that might significantly shorten my life?
Am I currently taking part in another medical research study?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, your treatment journey would be very similar to standard care, but with the addition of the 'ischemic conditioning' techniques. For Remote Ischemic Conditioning, a blood pressure cuff would be placed on your arm or leg and inflated/deflated a few times. For Local Ischemic Postconditioning, during your angioplasty, the doctor would briefly inflate and deflate the balloon in your heart artery several times before fully restoring blood flow. This would all happen while you are in the hospital. The study team would then follow your progress for a period to see how well you recover. The exact number of follow-up visits or the total duration of your participation would be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit if the combined conditioning techniques prove to better protect your heart during and after your heart attack compared to standard care alone, potentially leading to a better recovery. However, there's also a chance there might be no extra benefit from these new techniques. The risks associated with the conditioning techniques are generally low, mostly involving temporary discomfort from the blood pressure cuff, but any potential risks would be fully explained. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time without it affecting your medical care.

Locations (11)

Medizinische Universität Innsbruck
Verified postcode
Innsbruck, Austria
Klinikum Links der Weser
Verified postcode
Bremen, Germany
Herzzentrum Dresden
Verified postcode
Dresden, Germany
Universitätsklinikum Düsseldorf
Verified postcode
Düsseldorf, Germany
University Hospital Essen
Verified postcode
Essen, Germany
University Clinic Hamburg-Eppendorf
Verified postcode
Hamburg, Germany
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Verified postcode
Leipzig, Germany
Klinikum Ludwigshafen
Verified postcode
Ludwigshafen, Germany
University Heart Center Lübeck - University of Schleswig-Holstein
Verified postcode
Lübeck, Germany
Universitätsmedizin Rostock
Verified postcode
Rostock, Germany
University Hospital Tübingen
Verified postcode
Tübingen, Germany

Common questions

What is a 'STEMI' heart attack?

A STEMI is a very serious type of heart attack where there's a complete blockage in one of the heart's main arteries, causing significant damage to the heart muscle. It requires immediate medical attention.

What are 'ischemic conditioning' techniques?

These are gentle methods that involve briefly cutting off and then restoring blood flow to a limb (like your arm) or to the heart itself for very short periods. The idea is that these brief interruptions might help protect the heart from damage during a heart attack and its treatment.

Will I still get my standard heart attack treatment?

Yes, absolutely. Everyone in this study receives the standard, proven treatment called angioplasty to unblock the artery. The study is about *adding* these new techniques to see if they can provide extra protection.

What does 'high-risk' mean in this study?

In this study, 'high-risk' refers to patients whose heart attack has caused them to have more noticeable symptoms, such as significant breathlessness or requiring medication for fluid build-up, indicating a more severe impact on the heart.

Will I know if I'm getting the extra treatments?

This is a 'randomized' study, meaning you'll be assigned by chance to either receive the extra conditioning treatments or just the standard care. This helps researchers fairly compare the two approaches, so you wouldn't know which group you are in.