Sodium Nitrite in Acute Myocardial Infarction
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to determine whether the intravenous infusion of sodium nitrite safely prevents ischemia-reperfusion injury in subjects with acute myocardial infarction resulting in improved left ventricular function.
Full description
Despite reperfusion therapies, significant myocardial injury continues to occur from ischemic-reperfusion injury. Studies in animal models of acute myocardial infarction suggest that an infusion of sodium nitrite, which is nonenzymatically converted to nitric oxide in the setting of ischemia, significantly reduces ischemia-reperfusion injury resulting in smaller infarcts and improved left ventricular function. The objectives of this phase 2 trial are to determine the tolerability and safety of a 48-hour infusion of sodium nitrite in patients with an acute ST-segment elevation myocardial infarction receiving percutaneous coronary intervention. The efficacy of a 48-hour infusion of sodium nitrite will be determined by noninvasive imaging to determine infarct size and left ventricular function.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Acute ST segment elevation myocardial infarction
- Eligible for percutaneous coronary intervention
Exclusion criteria
- Cardiogenic shock
- Cardiac arrest
- Prior infarct in the infarct related artery
- Hemoglobinopathy, Glucose-6 Phosphate Dehydrogenase (G6PD) deficiency
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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