Acute Anterior ST Segment Elevation Myocardial Infarction
Conditions
Keywords
Nivolumab, acute anterior ST segment elevation myocardial infarction
Brief summary
Myocardial infarction (MI) is a major contributor to morbidity and mortality in China. The goal of this interventional, randomised controlled clinical trial is to evaluate the effectiveness and safety of a single administration of Nivolumab to the patients presenting with an acute anterior ST-segmental elevated myocardial infarction. Researchers will investigate if Nivolumab treatment can effectively and safely reduce infarct size as well as improve cardiac function of the patients with acute myocardial infarction.
Detailed description
The efficacy and safety of nivolumab as compared with placebo in the treatment of acute anterior ST segment elevation myocardial infarction are not known. In this phase 1/2, randomized, placebo-controlled, open-label trial, we randomly assigned adults with acute anterior ST segment elevation myocardial infarction to receive either nivolumab (5mg/kg for single administration) or placebo. The primary end points were difference in infarct size/LV mass% from baseline to 3 months after Nivolumab administration and the incidence of adverse events during 3 months after Nivolumab administration. Secondary end points included difference in LVEF%, LVESV/Body surface area, LVEDV/Body surface area, Trponin T and proBNP from baseline to 3 months after Nivolumab administration.
Interventions
DRUGNivolumab
Single administration of Nivolumab on the third day of revascularization after acute anterior ST segment elevation myocardial infarction. The active drug Nivolumab will be administered at a standard dose (5mg/kg) dissolved in 100ml 0.9%NaCl solution. Nivolumab was given at a rate of 15-25 drops per minute, and the intravenous infusion time exceeded 1 hour.
OTHERPlacebo
Single administration of Placebo on the third day of revascularization after acute anterior ST segment elevation myocardial infarction. Patients assigned to the placebo treatment group will receive an intravenous infusion of 100 ml 0.9% NaCl solution at a rate of 15-25 drops/min for an IV infusion duration of more than 1 hour.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ∆Infarct size/Left Ventricular mass% | 3 months | Difference in Infarct size/Left ventricular mass% from baseline to 3 months after Nivolumab administration. |
| The incidence of adverse events | up to 3 months | The incidence of adverse events during 3 months after Nivolumab treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ∆Left ventricle end diastolic volume/Body surface area | 3 months | Difference in Left ventricle end diastolic volume/Body surface area from baseline to 3 months after Nivolumab administration. |
| ∆Left ventricle ejection fraction% | 3 months | Difference in Left ventricle ejection fraction% from baseline to 3 months after Nivolumab administration. |
| ∆proBNP | 3 months | Difference in concentration of proBNP from baseline to 3 months after Nivolumab administration. |
| ∆Troponin T | 3 months | Difference in concentration of Troponin T from baseline to 3 months after Nivolumab administration. |
| ∆Left ventricle end systolic volume/Body surface area | 3 months | Difference in Left ventricle end systolic volume/Body surface area from baseline to 3 months after Nivolumab administration. |
Contacts
Primary ContactYinchuan Xu, PhD
Backup ContactChangle Ke, PhD
Outcome results
None listed