About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Combined antioxidant therapy
- Placebo
Treatment groups
Sponsors and collaborators
University of Chile
Lead sponsor
Hospital San Juan de Dios,Chile
Collaborator