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Sodium Nitrite in Acute Myocardial Infarction

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Johns Hopkins University
Sponsor:
Collaborator:
Hope Pharmaceuticals
Information provided by (Responsible Party):
Steven P. Schulman, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00924118
First received: June 17, 2009
Last updated: March 25, 2013
Last verified: March 2013

June 17, 2009
March 25, 2013
July 2009
July 2014   (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 ClinicalTrials.gov 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.

Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
September 2014
July 2014   (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
Both
21 Years to 75 Years
No
Contact: Steven P Schulman, MD 410-955-7378 sschulma@jhmi.edu
Contact: Rhondalyn C McLean, MD 410-502-5524 rmclean5@jhmi.edu
United States
 
NCT00924118
00023049
Yes
Steven P. Schulman, MD, Johns Hopkins University
Johns Hopkins University
Hope Pharmaceuticals
Principal Investigator: Steven P Schulman, MD Johns Hopkins University
Johns Hopkins University
March 2013

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