Sodium Nitrite in Acute Myocardial Infarction

Phase 2

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: Sodium Nitrite

• Registration Number: NCT00924118
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-17
• Study First Posted: 2009-06-18
• Study Start: 2009-07
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2017-07-28
• Results First Submitted QC: 2017-08-25
• Results First Posted: 2017-09-25
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-11
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Acute ST segment elevation myocardial infarction
• Eligible for percutaneous coronary intervention

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Exclusion Criteria

• Cardiogenic shock
• Cardiac arrest
• Prior infarct in the infarct related artery
• Hemoglobinopathy, Glucose-6 Phosphate Dehydrogenase (G6PD) deficiency

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Nitrite	Sodium Nitrite	Dose escalation of sodium nitrite.

Primary Outcome Measures

Name	Time	Method
Ischemia Area at Risk as Determined by Paired Single-photon Computed Tomography Studies With Technetium Tc99m Sestamibi.	4-5 days from enrollment	Measured as percentage of left ventricle

Secondary Outcome Measures

Name	Time	Method
Left Ventricular Infarct Size	4-5 days following enrollment	Left ventricular infarct size by Magnetic Resonance Imaging (MRI). Calculated percentage of the left ventricular mass by MRI that has undergone infarction.

Trial Locations

Locations (3)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

University of Massachusetts Medical School; 🇺🇸 Worcester, Massachusetts, United States