We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sodium Nitrite in Acute Myocardial Infarction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00924118
First Posted: June 18, 2009
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hope Pharmaceuticals
Information provided by (Responsible Party):
Johns Hopkins University
  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
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 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 ]

    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.

    Too few subjects received Tc99m sestamibi to make statistical comparisons between the groups regarding infarct size normalized for the ischemia area at risk.



Secondary Outcome Measures:
  • Left Ventricular Infarct Size [ Time Frame: 4-5 days following enrollment ]
    Left ventricular infarct size by magnetic resonance imaging. Calculated percentage of the left ventricular mass by MRI that has undergone infarction.


Enrollment: 30
Study Start Date: July 2009
Study Completion Date: June 2016
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.
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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, Glucose-6 Phosphate Dehydrogenase (G6PD) deficiency
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924118


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

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00924118     History of Changes
Other Study ID Numbers: 00023049
First Submitted: June 17, 2009
First Posted: June 18, 2009
Results First Submitted: July 28, 2017
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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