Nitrites in Acute Myocardial Infarction

University of Aberdeen200 enrolled

Overview

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)?"

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Acute ST Elevation Myocardial Infarction

Interventions

sodium nitriteDRUG

sterile solution containing low dose sodium nitrite dissolved in 5ml water injected intravenously over a period of 2½ - 5 minutes immediately prior to opening of the infarct related artery using Percutaneous Coronary Intervention

PlaceboOTHER

sterile solution containing 0.9%w/v sodium chloride in 5ml water injected intravenously over a period of 2½ - 5 minutes immediately prior to Percutaneous Coronary Intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Men aged ≥18 years, women aged ≥55 years, and women \<55years who are sterilised, or have had a hysterectomy or have effective contraception and thus where there is no possibility of them being pregnant; presenting within 12 hours of the onset of chest pain who have ST segment elevation of more than 1mm elevation in limb leads or 2mm elevation in two contiguous chest leads or new left bundle branch block (LBBB) and for whom the clinical decision has been made to treat with primary PCI will be eligible for enrolment. Occlusion of the culprit related artery (TIMI grade 0 or TIMI grade 1) will also be required for inclusion. Eligible patients will be of North European descent. Exclusion criteria * Historical or ECG evidence of previous myocardial infarction * Patients with prior coronary artery bypass grafting (CABG) * Prior revascularization procedure where this procedure (PCI) was performed in the same territory as the current infarct * Known or suspected pregnancy * Contra-indications to MRI * Patients with cardiac arrest or cardiogenic shock * Patients with left main coronary occlusion * Patients with known moderate to severe renal failure (estimated GFR \< 30mls/min), or liver failure * Patients with prior thrombolysis for this event * Patients with such Left Main disease which after PCI of their culprit lesion (culprit lesions may be located in the LAD or LCx or RCA) are likely to require CABG within the time course of the study period (6 months).

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

Outcomes

Primary Outcomes

Infarct size corrected for area at risk (using ESA)

Time frame: 6-8 days post injection

Secondary Outcomes

Left ventricular ejection fraction and end systolic volume index

Time frame: 6-8 days and 6 months post injection

Plasma creatine kinase

Time frame: 72 hours post injection

Troponin I

Time frame: 72 hours post injection

Infarct size corrected for area at risk

Time frame: 6 months

Infarct size corrected for area at risk (using T2)

Time frame: 6-8 days

Data from ClinicalTrials.gov

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