Electrocardiogram ST segment elevation – Trials in Disease

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Ongoing Clinical Trials for ST-Elevation Myocardial Infarction

Currently, there is 1 ongoing clinical trial investigating new treatment approaches for patients who have experienced ST-elevation myocardial infarction (STEMI), a severe type of heart attack. This trial is exploring the potential of rituximab, a medication that targets the immune system, to improve heart function recovery following a STEMI. The trial is being conducted across multiple countries in Europe. (Also known as: Electrocardiogram ST Segment Elevation, STEMI)

Clinical trial locations

Study on Rituximab for Patients with Acute Myocardial Infarction

This clinical trial is investigating whether rituximab, a medication that works on the immune system, can help improve heart function in patients who have suffered a STEMI, which is a severe type of heart attack caused by a complete blockage in a major heart artery. The study compares the effects of a single injection of rituximab against a placebo to determine if it can enhance the heart’s ability to pump blood six months after the heart attack.

Main inclusion criteria:

  • Adults over 18 years of age with no upper age limit
  • Clinical evidence of an anterior STEMI with specific changes visible on an electrocardiogram (ECG)
  • Complete blockage of the left anterior descending coronary artery confirmed by urgent heart imaging
  • Heart attack symptoms that started within 48 hours before the planned emergency heart procedure (primary percutaneous coronary intervention or PPCI)
  • Ability to receive the study medication infusion within 3 hours after the PPCI procedure
  • Women must be postmenopausal or have had surgery to remove the uterus and/or ovaries
  • Willingness to provide written informed consent

Main exclusion criteria:

  • Patients who have not experienced a STEMI
  • Patients outside the specified age range
  • Patients considered part of a vulnerable population requiring special protection

Trial focus and procedures: The main goal of this study is to assess whether rituximab can improve the heart’s pumping ability after a severe heart attack. Participants will receive either rituximab or a placebo through an intravenous infusion within 3 hours after their emergency heart procedure. Heart function will be carefully monitored using cardiac magnetic resonance imaging (CMR) at 6 months to measure the left ventricular ejection fraction, which indicates how well the heart pumps blood. Additional assessments will take place between day 3 and day 7 after treatment to evaluate the extent of heart muscle damage, tissue swelling, and any treatment-related side effects. Supporting medications such as paracetamol, clemastine, chlorphenamine maleate, methylprednisolone, and sodium chloride may also be used as part of the treatment process.

Investigational drug: Rituximab is a monoclonal antibody medication that targets specific cells in the immune system. In this trial, it is being studied for its potential to reduce inflammation and heart damage following a STEMI, with the aim of improving heart function recovery. It is administered as a single injection and is not yet widely used for this purpose in standard medical practice.

Summary

There is currently one ongoing clinical trial focused on STEMI, being conducted across five European countries: Czechia, France, Germany, Netherlands, and Spain. This multi-country trial reflects international collaboration in exploring new treatment approaches for severe heart attacks. The trial is specifically investigating rituximab, a medication traditionally used in other conditions, to determine whether it can help patients recover better heart function after experiencing a STEMI. The study represents an innovative approach to improving outcomes for heart attack patients by targeting inflammation and immune system responses following heart muscle damage.

Ongoing Clinical Trials on Electrocardiogram ST segment elevation