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Sodium Nitrite in Acute Myocardial Infarction

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sodium Nitrite
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute myocardial infarction, Reperfusion injury, Nitric oxide

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Bayview Medical Center
  • Johns Hopkins Hospital
  • University of Massachusetts Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sodium Nitrite

Open Control

Arm Description

Dose escalation of sodium nitrite.

Standard therapy

Outcomes

Primary Outcome Measures

Ischemia Area at Risk as Determined by Paired Single-photon Computed Tomography Studies With Technetium Tc99m Sestamibi.
Measured as percentage of left ventricle

Secondary Outcome Measures

Left Ventricular Infarct Size
Left ventricular infarct size by Magnetic Resonance Imaging (MRI). Calculated percentage of the left ventricular mass by MRI that has undergone infarction.

Full Information

First Posted
June 17, 2009
Last Updated
April 11, 2018
Sponsor
Johns Hopkins University
Collaborators
Hope Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00924118
Brief Title
Sodium Nitrite in Acute Myocardial Infarction
Official Title
A Safety and Efficacy Evaluation of Sodium Nitrite Injection for the Prevention of Ischemia-Reperfusion Injury Associated With Acute Myocardial Infarction.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Hope Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute myocardial infarction, Reperfusion injury, Nitric oxide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium Nitrite
Arm Type
Experimental
Arm Description
Dose escalation of sodium nitrite.
Arm Title
Open Control
Arm Type
No Intervention
Arm Description
Standard therapy
Intervention Type
Drug
Intervention Name(s)
Sodium Nitrite
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ischemia Area at Risk as Determined by Paired Single-photon Computed Tomography Studies With Technetium Tc99m Sestamibi.
Description
Measured as percentage of left ventricle
Time Frame
4-5 days from enrollment
Secondary Outcome Measure Information:
Title
Left Ventricular Infarct Size
Description
Left ventricular infarct size by Magnetic Resonance Imaging (MRI). Calculated percentage of the left ventricular mass by MRI that has undergone infarction.
Time Frame
4-5 days following enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven P Schulman, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18519850
Citation
Gonzalez FM, Shiva S, Vincent PS, Ringwood LA, Hsu LY, Hon YY, Aletras AH, Cannon RO 3rd, Gladwin MT, Arai AE. Nitrite anion provides potent cytoprotective and antiapoptotic effects as adjunctive therapy to reperfusion for acute myocardial infarction. Circulation. 2008 Jun 10;117(23):2986-94. doi: 10.1161/CIRCULATIONAHA.107.748814. Epub 2008 Jun 2.
Results Reference
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PubMed Identifier
15841216
Citation
Duranski MR, Greer JJ, Dejam A, Jaganmohan S, Hogg N, Langston W, Patel RP, Yet SF, Wang X, Kevil CG, Gladwin MT, Lefer DJ. Cytoprotective effects of nitrite during in vivo ischemia-reperfusion of the heart and liver. J Clin Invest. 2005 May;115(5):1232-40. doi: 10.1172/JCI22493. Epub 2005 Apr 14.
Results Reference
background
PubMed Identifier
17495223
Citation
Rassaf T, Flogel U, Drexhage C, Hendgen-Cotta U, Kelm M, Schrader J. Nitrite reductase function of deoxymyoglobin: oxygen sensor and regulator of cardiac energetics and function. Circ Res. 2007 Jun 22;100(12):1749-54. doi: 10.1161/CIRCRESAHA.107.152488. Epub 2007 May 10.
Results Reference
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Sodium Nitrite in Acute Myocardial Infarction

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