Phase 2
N=30
Sodium Nitrite in Acute Myocardial Infarction
Acute Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT00924118 ↗Enrolled (actual)
30
Serious AEs
13.3%
Results posted
Sep 2017
Primary outcome: Primary: Ischemia Area at Risk as Determined by Paired Single-photon Computed Tomography Studies With Technetium Tc99m Sestamibi.
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sodium Nitrite (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ischemia Area at Risk as Determined by Paired Single-photon Computed Tomography Studies With Technetium Tc99m Sestamibi. |
— | — |
| SECONDARY Left Ventricular Infarct Size |
15.5; 24 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00924118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.