Sodium Nitrite in Acute Myocardial Infarction
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|ClinicalTrials.gov Identifier: NCT00924118|
Recruitment Status : Completed
First Posted : June 18, 2009
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Drug: Sodium Nitrite||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety and Efficacy Evaluation of Sodium Nitrite Injection for the Prevention of Ischemia-Reperfusion Injury Associated With Acute Myocardial Infarction.|
|Study Start Date :||July 2009|
|Primary Completion Date :||June 2016|
|Study Completion Date :||June 2016|
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.
- 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.
- 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.
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
|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|
|Principal Investigator:||Steven P Schulman, MD||Johns Hopkins University|