Nitrites in Acute Myocardial Infarction (NIAMI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NHS Grampian
Medical Research Council
St George's Healthcare NHS Trust
Brighton and Sussex University Hospitals NHS Trust
Imperial College London
University of Birmingham
Information provided by (Responsible Party):
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01388504
First received: July 1, 2011
Last updated: July 4, 2013
Last verified: July 2013

July 1, 2011
July 4, 2013
July 2011
June 2013   (final data collection date for primary outcome measure)
Infarct size corrected for area at risk (using ESA) [ Time Frame: 6-8 days post injection ] [ Designated as safety issue: No ]
Infarct size corrected for area at risk [ Time Frame: 10-14 days post injection ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01388504 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Infarct size corrected for area at risk [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Infarct size corrected for area at risk (using T2) [ Time Frame: 6-8 days ] [ Designated as safety issue: No ]
  • Infarct size corrected for area at risk [ Time Frame: 6 months post injection ] [ Designated as safety issue: No ]
  • LV ejection fraction and end systolic volume index [ Time Frame: 10-14 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 ]
Not Provided
Not Provided
 
Nitrites in Acute Myocardial Infarction
Does Sodium Nitrite Administration Reduce Ischaemia-reperfusion Injury in Patients Presenting With Acute ST Segment Elevation Myocardial Infarction?

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute ST Elevation Myocardial Infarction
  • 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
  • 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
  • Experimental: sodium nitrite
    Intervention: Drug: sodium nitrite
  • Placebo Comparator: placebo
    sterile solution containing 0.9%w/v sodium chloride in 5ml water injected intravenously over a period of 2½ - 5 minutes
    Intervention: Other: Placebo
Siddiqi N, Bruce M, Neil CJ, Jagpal B, Maclennon G, Cotton SC, Papadopoulo SA, Bunce N, Lim P, Schwarz K, Singh S, Hildick-Smith D, Horowitz JD, Madhani M, Boon N, Kaski JC, Dawson D, Frenneaux MP. Protocol: does sodium nitrite administration reduce ischaemia-reperfusion injury in patients presenting with acute ST segment elevation myocardial infarction? Nitrites in acute myocardial infarction (NIAMI). J Transl Med. 2013 May 6;11:116. doi: 10.1186/1479-5876-11-116.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
January 2014
June 2013   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01388504
3/030/10
Yes
University of Aberdeen
University of Aberdeen
  • NHS Grampian
  • Medical Research Council
  • St George's Healthcare NHS Trust
  • Brighton and Sussex University Hospitals NHS Trust
  • Imperial College London
  • University of Birmingham
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
University of Aberdeen
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP