Nitrites in Acute Myocardial Infarction (NIAMI)
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Purpose
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)?"
| Condition | Intervention | Phase |
|---|---|---|
|
Acute ST Elevation Myocardial Infarction |
Drug: sodium nitrite Other: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Does Sodium Nitrite Administration Reduce Ischaemia-reperfusion Injury in Patients Presenting With Acute ST Segment Elevation Myocardial Infarction? |
- Infarct size corrected for area at risk [ Time Frame: 6 months post injection ] [ Designated as safety issue: No ]
- Left ventricular ejection fraction and end systolic volume index [ Time Frame: 6-8 days and 6 months post injection ] [ Designated as safety issue: No ]
- Plasma creatine kinase [ Time Frame: 72 hours post injection ] [ Designated as safety issue: No ]
- Troponin I [ Time Frame: 72 hours post injection ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: sodium nitrite |
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
|
|
Placebo Comparator: placebo
sterile solution containing 0.9%w/v sodium chloride in 5ml water injected intravenously over a period of 2½ - 5 minutes
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| Contact: Seonaidh Cotton, PhD | +44 1224 551126 | s.c.cotton@abdn.ac.uk |
| United Kingdom | |
| Aberdeen Royal Infirmary | Recruiting |
| Aberdeen, United Kingdom, AB25 2ZD | |
| Contact: Michael Frenneaux, MD FRCP 01224 437970 m.p.frenneaux@abdn.ac.uk | |
| Contact: Nishat Siddiqi, MBBCh MRCP n.siddiqi@abdn.ac.uk | |
| Brighton and Sussex University Hospitals NHS Trust | Recruiting |
| Brighton, United Kingdom | |
| Contact: David Hildick-Smith, MD FRCP David.hildick-smith@bsuh.nhs.uk | |
| St George's Healthcare NHS Trust | Recruiting |
| London, United Kingdom, SW17 0QT | |
| Contact: Juan Carlos Kaski, MD FRCP jkaski@sghms.ac.uk | |
| Study Director: | Michael Frenneaux, MD, FRCP | University of Aberdeen |
| Principal Investigator: | Juan Carlos Kaski, MD, FRCP | St George's Healthcare NHS Trust |
| Principal Investigator: | David HildickSmith, MD, FRCP | Brighton and Sussex University Hospitals NHS Trust |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Aberdeen |
| ClinicalTrials.gov Identifier: | NCT01388504 History of Changes |
| Other Study ID Numbers: | 3/030/10 |
| Study First Received: | July 1, 2011 |
| Last Updated: | April 15, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Reperfusion Injury Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Postoperative Complications |
ClinicalTrials.gov processed this record on May 19, 2013