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A study evaluating the effect of methylprednisolone compared to sodium chloride in patients with a heart attack

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study investigates the effects of a high-dose steroid treatment in individuals experiencing a ST-segment Elevation Myocardial Infarction, which is a serious type of heart attack. The research aims to evaluate whether giving a large dose of the medication methylprednisolone through an intravenous infusion, which means the medicine is delivered directly into a vein, can affect the rate of death from any cause in these patients. Participants will receive either the active medication or a placebo consisting of sodium chloride.

The research process

The trial runs in 1 step.

Step 1
Administration of medication
After joining the study, a single intravenous infusion, which is a liquid delivered directly into a vein, is administered.
The treatment consists of either the test medication, which is methylprednisolone at a dose of 250 mg, or a placebo, which is a sodium chloride (saltwater) solution of 4 ml.

Who can join the trial?

6 criteria

You must be 18 years of age or older, which includes women who are able to have children.
You must have experienced a sudden onset of chest pain that started less than 24 hours ago.
You must have been diagnosed with STEMI, which is a serious type of heart attack where a specific pattern of electrical activity is seen on an electrocardiogram (a test that records the heart's electrical signals).
The electrocardiogram must show specific patterns of ST-segment elevation, which refers to a specific part of the heart's electrical wave being higher than normal, indicating a blockage in a heart artery.
The patterns may also include a new left bundle branch block, which is a change in the electrical conduction system of the heart that affects how the heart beats.
The diagnosis may also be based on specific patterns of ST depression, where the electrical wave is lower than normal, suggesting certain types of heart muscle damage or blockages in major arteries.

Who cannot join the trial?

3 criteria

You are suspected of having a type of heart attack other than Type I acute myocardial infarction, which is a heart attack caused by a sudden blockage in one of the heart's arteries.
You experienced a cardiac arrest, which is when the heart suddenly stops beating, outside of a hospital setting.
You have a known allergy, which is an extreme reaction by your immune system, to glucocorticoids, which are a type of steroid medication used to reduce inflammation.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Aarhus University Hospital
Aarhus, Denmark
Verified
Odense University Hospital
Odense, Denmark
Verified
Rigshospitalet
Copenhagen, Denmark

Trial locations

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Investigated drugs

Methylprednisolone is a type of steroid medication used to reduce inflammation and suppress the immune system. In this study, it is being tested to see if giving a high dose before reaching the hospital can improve outcomes for patients experiencing a specific type of heart attack.

What is already known about the treatment

Methylprednisolone
This medication is a corticosteroid that is given through an intravenous infusion into a vein. It is a well-established medicine used to treat various conditions involving severe inflammation and immune system responses. At a molecular level, it works by entering cells and turning off the production of substances that cause swelling and irritation in the body. It belongs to a class of drugs known as glucocorticoids.
Sodium chloride
This substance is a simple salt solution administered through an intravenous infusion into a vein. In this clinical trial, it is used as a placebo, which means it is a substance that has no active medicinal effect to serve as a comparison. It is commonly used in medical settings to keep a patient hydrated or to dilute other medications. It is classified as a saline solution used for diluting or transporting other substances.

Investigated diseases

ST-segment Elevation Myocardial Infarction - This condition occurs when a coronary artery becomes completely blocked, preventing blood flow to a part of the heart muscle. This lack of oxygen causes damage to the heart tissue. The condition typically develops suddenly and involves specific changes in the heart's electrical activity. As the blockage persists, the affected muscle cells may become injured or die.