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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
  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?

Resource links provided by NLM:


Further study details as provided by University of Aberdeen:

Primary Outcome Measures:
  • Infarct size corrected for area at risk (using ESA) [ Time Frame: 6-8 days post injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: January 2014
Primary Completion Date: June 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388504

Locations
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZD
Brighton and Sussex University Hospitals NHS Trust
Brighton, United Kingdom
St George's Healthcare NHS Trust
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
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
Investigators
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 by University of Aberdeen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: July 4, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014