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Health Condition(s) or Problem
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Acute ST Elevation Myocardial Infarction
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Lay Summary
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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)?"
(from ClinicalTrials.gov)
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Who can enter the trial
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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).
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Who cannot enter the trial
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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).
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What will happen
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Drug; sodium nitrite; 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; sodium nitrite; Other; Placebo; 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; placebo
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Primary aim
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Infarct size corrected for area at risk
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Secondary Aim
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Left ventricular ejection fraction and end systolic volume index; 6-8 days and 6 months post injection; No; Plasma creatine kinase; 72 hours post injection; No; Troponin I; 72 hours post injection; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://viis.abdn.ac.uk/HSRU/chart/public/trials/TrialDetails.aspx?page=current-trials&tid=48
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Recruitment Status
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Recruiting
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Nation
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Scotland, England
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Location
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Aberdeen, Brighton, London
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