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Sodium Nitrite in Acute Myocardial Infarction

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2016 by Steven P. Schulman, MD, 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: March 24, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Acute Myocardial Infarction Drug: Sodium Nitrite Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Evaluation of Sodium Nitrite Injection for the Prevention of Ischemia-Reperfusion Injury Associated With Acute Myocardial Infarction.

Resource links provided by NLM:

Further study details as provided by Steven P. Schulman, MD, Johns Hopkins University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Left ventricular volumes, ejection fraction, and infarct size by magnetic resonance imaging. [ Time Frame: 4-5 days following enrollment ]

Estimated Enrollment: 30
Study Start Date: July 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium Nitrite
Dose escalation of sodium nitrite.
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.
Other Name: None available
No Intervention: Open control
Subjects randomized to open control will receive no experimental therapy.

Detailed 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.

Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00924118

Contact: Steven P Schulman, MD 410-955-7378
Contact: Jeffrey R Rade, MD 508-334-3452

United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21205
Contact: Steven P Schulman, MD    410-955-7378   
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Steven P Schulman, MD         
United States, Massachusetts
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
Johns Hopkins University
Hope Pharmaceuticals
Principal Investigator: Steven P Schulman, MD Johns Hopkins University
  More Information

Responsible Party: Steven P. Schulman, MD, Professor of Medicine, Johns Hopkins University Identifier: NCT00924118     History of Changes
Other Study ID Numbers: 00023049
Study First Received: June 17, 2009
Last Updated: March 24, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Steven P. Schulman, MD, Johns Hopkins University:
Acute myocardial infarction
Reperfusion injury
Nitric oxide

Additional relevant MeSH terms:
Myocardial Infarction
Reperfusion Injury
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications processed this record on August 17, 2017