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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 22, 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
June 17, 2009
June 18, 2009
July 28, 2017
September 22, 2017
September 22, 2017
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 ]

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.

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 ]
Complete list of historical versions of study NCT00924118 on ClinicalTrials.gov Archive Site
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.
Left ventricular volumes, ejection fraction, and infarct size by magnetic resonance imaging. [ Time Frame: 4-5 days following enrollment ]
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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Completed
30
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, Glucose-6 Phosphate Dehydrogenase (G6PD) deficiency
Sexes Eligible for Study: All
21 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00924118
00023049
Yes
Not Provided
Plan to Share IPD: No
Johns Hopkins University
Johns Hopkins University
Hope Pharmaceuticals
Principal Investigator: Steven P Schulman, MD Johns Hopkins University
Johns Hopkins University
August 2017

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