Sodium Nitrite in Acute Myocardial Infarction
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 5/16/2018 |
| Start Date: | July 2009 |
| End Date: | June 2016 |
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.
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.
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.
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
We found this trial at
3
sites
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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4940 Eastern Ave
Baltimore, Maryland 21224
Baltimore, Maryland 21224
(410) 550-0100
Phone: 410-955-7378
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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1800 Orleans St.
Baltimore, Maryland 21287
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Steven P Schulman, MD
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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