Sodium Nitrite in Acute Myocardial Infarction
A Safety and Efficacy Evaluation of Sodium Nitrite Injection for the Prevention of Ischemia-Reperfusion Injury Associated With Acute Myocardial Infarction.
  • Phase

    Phase 2
  • Study Type

  • Study Participants

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.
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.
Study Started
Jul 31
Primary Completion
Jun 30
Study Completion
Jun 30
Results Posted
Sep 25
Last Update
May 14

Drug Sodium Nitrite

Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects.

Sodium Nitrite Experimental

Dose escalation of sodium nitrite.

Open Control No Intervention

Standard therapy


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


Sodium Nitrite

Open Control

All Events

Event Type Organ System Event Term Sodium Nitrite Open Control

Ischemia Area at Risk as Determined by Paired Single-photon Computed Tomography Studies With Technetium Tc99m Sestamibi.

Measured as percentage of left ventricle

Sodium Nitrite

Open Control

Left Ventricular Infarct Size

Left ventricular infarct size by Magnetic Resonance Imaging (MRI). Calculated percentage of the left ventricular mass by MRI that has undergone infarction.

Sodium Nitrite

infarct percentage of left ventricle (Mean)
Full Range: 7.0 to 17.0

Open Control

infarct percentage of left ventricle (Mean)
Full Range: 17.0 to 31.0



Age, Continuous

years (Mean)
Full Range: 44.0 to 76.0

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Sodium Nitrite

Open Control