Sodium Nitrite in Acute Myocardial Infarction

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Johns Hopkins University
Hope Pharmaceuticals
Information provided by (Responsible Party):
Steven P. Schulman, MD, Johns Hopkins University Identifier:
First received: June 17, 2009
Last updated: June 1, 2015
Last verified: June 2015

June 17, 2009
June 1, 2015
July 2009
June 2016   (final data collection date for primary outcome measure)
Primary efficacy outcome is a to determine whether sodium nitrite safely reduces infarct size normalized for the ischemia area at risk as determined by paired single-photon computed tomography studies with technetium Tc99m sestamibi. [ Time Frame: 4-5 days from enrollment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00924118 on Archive Site
Left ventricular volumes, ejection fraction, and infarct size by magnetic resonance imaging. [ Time Frame: 4-5 days following enrollment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
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.

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.

Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myocardial Infarction
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.
  • Experimental: Sodium Nitrite
    Dose escalation of sodium nitrite.
    Intervention: Drug: Sodium Nitrite
  • No Intervention: Open control
    Subjects randomized to open control will receive no experimental therapy.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2016
June 2016   (final data collection date for primary outcome measure)

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, GG6PD deficiency
21 Years to 75 Years
Contact: Steven P Schulman, MD 410-955-7378
Contact: Jeffrey R Rade, MD 508-334-3452
United States
Steven P. Schulman, MD, Johns Hopkins University
Johns Hopkins University
Hope Pharmaceuticals
Principal Investigator: Steven P Schulman, MD Johns Hopkins University
Johns Hopkins University
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP