Nitrites in Acute Myocardial Infarction

NCT01388504 | Completed Phase 2 DMC

• 1 other identifier: 3/030/10
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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)?"

Conditions

Acute ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Infarct size corrected for area at risk (using ESA)

  6-8 days post injection

Secondary Outcomes (5)

• 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

Study Arms (2)

sodium nitrite

EXPERIMENTAL

Drug: sodium nitrite

placebo

PLACEBO COMPARATOR

sterile solution containing 0.9%w/v sodium chloride in 5ml water injected intravenously over a period of 2½ - 5 minutes

Other: Placebo

Interventions

sodium nitrite DRUG

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

Placebo OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator
• Medical Research Council: collaborator
• St George's Healthcare NHS Trust: collaborator
• Brighton and Sussex University Hospitals NHS Trust: collaborator
• Imperial College London: collaborator
• University of Birmingham: collaborator

Study Sites (3)

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZD, United Kingdom

Location

Brighton and Sussex University Hospitals NHS Trust

Brighton, United Kingdom

Location

St George's Healthcare NHS Trust

London, SW17 0QT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23648219 DERIVED

MeSH Terms

Interventions

Sodium Nitrite

Intervention Hierarchy (Ancestors)

Nitrites; Nitrous Acid; Nitrogen Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Michael Frenneaux, MD, FRCP

  University of Aberdeen

  STUDY DIRECTOR

• Juan Carlos Kaski, MD, FRCP

  St George's Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

• David HildickSmith, MD, FRCP

  Brighton and Sussex University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 6, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 21, 2016

Record last verified: 2015-11

Locations

GB (3)