Effect of Nivolumab vs Placebo in Patients With Acute Myocardial Infarction: A Randomized Clinical Trial

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · May 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Nivolumab to see if it can help patients who have had a severe heart attack, specifically a type known as acute anterior ST-segment elevation myocardial infarction (MI). The main goal is to find out if a single dose of Nivolumab can reduce the damage to the heart muscle and improve how well the heart works after a heart attack. Researchers are hoping that this treatment can make a meaningful difference for patients recovering from such serious heart issues.

To participate in the trial, individuals need to be between 18 and 80 years old and should have experienced an acute anterior ST-segment elevation heart attack. They must also undergo a procedure called coronary angiography within 24 hours of chest pain to open blocked arteries. However, some people may not be eligible, including those with severe heart problems, certain kidney issues, or pregnant women. Participants in the trial will receive either Nivolumab or a placebo (a substance with no active treatment) and will be monitored for their heart function and overall health. It's important to note that the trial is not yet recruiting participants, so there will be additional information available once it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 80 years;
• • 2. Signed informed consent and expected compliance with protocol;
• • 3. Acute anterior ST segment elevation myocardial infarction;
• • 4. Emergency coronary angiography for revascularization of occlusive vessels within 24 hours of chest pain onset;
• • 5. Left ventricular ejection fraction is less than 45% (LVEF≤45%) as revealed by Echo within 72 hours after revascularization.
• Exclusion Criteria:
• • 1. Cardiogenic shock;
• • 2. Cardiac arrest/ventricular fibrillation;
• • 3. History of severe renal failure, glomerular filtration rate (eGFR) \< 30ml/min;
• • 4. History of severe infection, hepatobiliary obstruction or malignant tumor;
• • 5. Receiving immunosuppressive therapy;
• • 6. Women who are pregnant or may become pregnant;
• • 7. There are contraindications to study drugs or magnetic resonance examination;
• • 8. No written informed consent was obtained.