Sodium Nitrite in 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.
|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.|
- 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 ]
- Left ventricular volumes, ejection fraction, and infarct size by magnetic resonance imaging. [ Time Frame: 4-5 days following enrollment ] [ Designated as safety issue: No ]
|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)|
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.
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.
|Contact: Steven P Schulman, MDemail@example.com|
|Contact: Rhondalyn C McLean, MDfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Steven P Schulman, MD||Johns Hopkins University|