Nitrites in Acute Myocardial Infarction

Phase 2

Completed

• Conditions: Acute ST Elevation Myocardial Infarction
• Interventions: Drug: sodium nitrite; Other: Placebo

• Registration Number: NCT01388504
• Lead Sponsor: University of Aberdeen

Brief Summary

The research question to be addressed is "Does a 2.5 - 5 minute systemic intravenous injection of sodium nitrite administered immediately before opening of the infarct related artery result in significant reduction of ischaemia reperfusion injury in patients with first acute ST elevation myocardial infarction (MI)?"

Detailed Description

There are estimated to be 125,000 acute myocardial infarctions (heart attacks) in the UK every year. Although substantial progress has been made in reducing the infarct size by prompt opening of the infarct related artery (with thrombolytic therapy or percutaneous coronary intervention (PCI)), effective therapy to further reduce the infarct size would substantially reduce the risk of the patient subsequently developing heart failure.

There is a growing body of evidence from studies in animals that the use of nitrites may help in reducing the infarct size, although this has not been tested in man.

In this phase 2/3 study, the investigators propose to investigate the effect of sodium nitrite injection on infarct size. Eligible patients will be males aged 18 and over and females aged 55 and over, presenting within 12 hours of the onset of chest pain, who are suitable for treatment with percutaneous coronary intervention. Those who give verbal agreement to take part will receive a 2.5-5 minute injection of sodium nitrite (or placebo) immediately prior to the blocked artery being opened with percutaneous coronary intervention.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-01
• Study First Submitted QC: 2011-07-05
• Study First Posted: 2011-07-06
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-11
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sodium nitrite	sodium nitrite	-
placebo	Placebo	sterile solution containing 0.9%w/v sodium chloride in 5ml water injected intravenously over a period of 2½ - 5 minutes

Primary Outcome Measures

Name	Time	Method
Infarct size corrected for area at risk (using ESA)	6-8 days post injection

Secondary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction and end systolic volume index	6-8 days and 6 months post injection
Plasma creatine kinase	72 hours post injection
Troponin I	72 hours post injection
Infarct size corrected for area at risk	6 months
Infarct size corrected for area at risk (using T2)	6-8 days

Trial Locations

Locations (3)

Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, United Kingdom

Brighton and Sussex University Hospitals NHS Trust; 🇬🇧 Brighton, United Kingdom

St George's Healthcare NHS Trust; 🇬🇧 London, United Kingdom