The goal of this clinical trial is to learn if a combined antioxidant therapy (CAT) can reduce heart damage caused by the return of blood flow after blocked arteries are reopened in adults with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). It will also learn about the safety of this treatment. The main questions it aims to answer are:
1. Does combined antioxidant therapy lower infarct size, measured by cardiac magnetic resonance imaging (CMR), compared with placebo? 2. Does combined antioxidant therapy improve heart function, blood biomarkers of heart injury, and short-term clinical outcomes? 3. What problems do participants have when receiving the therapy?
Researchers will compare CAT to placebo (a look-alike infusion with no active drug) to see if the treatment lowers infarct size after STEMI.
Participants will:
* Be randomly assigned to receive either CAT or placebo * Receive the study infusion before and during primary PCI, in addition to standard treatment for STEMI * Have blood tests to measure heart injury, oxidative stress, inflammation, and drug levels * Undergo cardiac magnetic resonance imaging about 3 to 7 days after STEMI. * Be followed for clinical outcomes and safety for 30 days.
Age 18 years or older
First anterior ST-segment elevation myocardial infarction (STEMI)
Symptom onset within 6 hours before presentation
Eligible for primary percutaneous coronary intervention (PCI)
Prior myocardial infarction
Cardiogenic shock, defined as Society for Cardiovascular Angiography and Interventions (SCAI) shock class D or E.
Prior thrombolytic therapy for the index event.
Chronic kidney disease, defined as serum creatinine greater than 1.5 mg/dL or dialysis.
Parallel
Combined antioxidant therapy
DrugCombined Antioxidant Therapy consisting of ascorbate, N-acetylcysteine and deferoxamine
Placebo
DrugMatching placebo infusion administered before reperfusion and during primary PCI.
Infarct Size
Infarct size by CMR: infarct size will be expressed as a percentage of left ventricular (LV) mass (%LV). Infarct size will be measured using late gadolinium enhancement with manual contouring.
Cardiac Function and structure by CMR
Left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), and left ventricular mass measured by cardiac magnetic resonance imaging.
Cardiac function by Transthoracic echocardiography
Left ventricular systolic and diastolic function parameters, regional wall motion abnormalities, cardiac chamber sizes, and right ventricle systolic function
Myocardial Injury Biomarkers
High sensitivity cardiac Troponin I, creatine kinase (CK), and CK-MB. For each biomarker, peak value, area under the curve (AUC 0-48 hours), and change from baseline will be assessed.
Biomarkers of oxidative stress
Ferric reducing ability of plasma (FRAP), malondialdehyde, F2-isoprostanes, reduced glutathione/oxidized glutathione ratio (GSH/GSSG), enzymatic activity of superoxide dismutase, glutathione peroxidase, and catalase.
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University of Chile
Lead sponsor
Hospital San Juan de Dios,Chile
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
