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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Left ventricular volumes, ejection fraction, and infarct size by magnetic resonance imaging. [ Time Frame: 4-5 days following enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (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.
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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00924118

Contacts
Contact: Steven P Schulman, MD 410-955-7378 sschulma@jhmi.edu
Contact: Rhondalyn C McLean, MD 410-502-5524 rmclean5@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Steven P Schulman, MD         
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21205
Contact: Steven P Schulman, MD    410-955-7378    sschulma@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Hope Pharmaceuticals
Investigators
Principal Investigator: Steven P Schulman, MD Johns Hopkins University
  More Information

Publications:
Responsible Party: Steven P. Schulman, MD, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00924118     History of Changes
Other Study ID Numbers: 00023049
Study First Received: June 17, 2009
Last Updated: March 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Acute myocardial infarction
Reperfusion injury
Nitric oxide

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Reperfusion Injury
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications

ClinicalTrials.gov processed this record on September 16, 2014