Nitroprusside for Prevention of no-Reflow in Primary Angioplasty

Study Overview
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Brief Summary
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In patients admitted with acute myocardial infarction, there is a total occlusion of a coronary artery. Even after emergency catheterization and angioplasty, in some patients, the resumed blood flow is suboptimal and impacts on heart function. The study is aimed at examining whether nitroprusside, an anti-hypertension medication, given directly into the coronary artery, can improve the blood flow after the removal of the obstruction that caused the infarction.

Detailed Description
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Inadequate myocardial tissue perfusion despite successful relief of the culprit occlusion and restoration of epicardial coronary flow for ST-segment elevation acute myocardial infarction (STEMI) results in poor outcome. The investigators hypothesized that nitroprusside (NTP) injected intracoronary immediately before angioplasty might prevent no-reflow and improve vessel flow and myocardial perfusion.

Official Title
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Intracoronary Nitroprusside for the Prevention of the No-Reflow Phenomenon Following Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction. A Randomized, Double Blind, Placebo-Controlled Clinical Trial

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Nitroprusside


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute ST elevation myocardial infarction (MI) patients planned for primary PCI Diagnostic angiography demonstrating a TIMI flow grade <3 in the coronary artery before the PCI Exclusion Criteria: An admission electrocardiogram (ECG) showing complete left bundle branch block or a paced rhythm Systolic blood pressure < 90 mmHg A history of coronary bypass operation A known allergic reaction to nitroprusside Chronic hemodialysis Intravenous drug abuse Pregnancy Rescue intervention after failed thrombolysis Contraindications to aspirin or clopidogrel Need for emergent coronary artery bypass surgery Inability to provide informed consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nitroprusside|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The coronary blood flow in the artery undergoing intervention following angioplasty as determined by the corrected Thrombolysis in Myocardial Infarction (TIMI) frame count (CTFC) |  |  | 
| Proportion of patients with complete ST-segment resolution immediately after percutaneous coronary intervention (PCI) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with TIMI grade 3 flow after the procedure |  |  | 
| The proportion of patients with myocardial grade 3 blush after the procedure |  |  | 
| The proportion of patients with complete ST-segment resolution at 24 hours post intervention |  |  | 
| The proportion of patients requiring intra-aortic balloon counter-pulsation and its duration of use |  |  | 
| Length of hospital stay |  |  | 
| The combined rate of target vessel revascularization, myocardial infarction or death at 180 days |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, angioplasty, nitric oxide, prevention, acute myocardial infarction