Nitrites in Acute Myocardial Infarction | Completed
Nitrites in Acute Myocardial Infarc... | Completed
Nitrites in Acute Myocardial Infarction
NIAMI

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Medical Conditions
  • Acute ST Elevation Myocardial Infarction
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT01388504

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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)?"
Research Details
  • 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.
Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : sodium nitrite, Other : Placebo

Study Arm Groups : sodium nitrite, placebo

Intervention Type
See Interventions above
Primary Outcome Measures
    Infarct size corrected for area at risk (using ESA); 6-8 days post injection
Secondary Outcome Measures
    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
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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).
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
St. George's Hospital
London
England
SW17 0QT
Aberdeen
AB25 2ZD
Brighton
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Does Sodium Nitrite Administration Reduce Ischaemia-reperfusion Injury in Patients Presenting With Acute ST Segment Elevation Myocardial Infarction?
EudraCT Number
Not available for this trial
Funder(s)
  • NHS Grampian
  • Medical Research Council
  • St George's Healthcare NHS Trust
  • Brighton and Sussex University Hospitals NHS Trust
  • Imperial College London
  • University of Birmingham
Other Study ID Numbers
3/030/10
Sponsor(s)
University of Aberdeen
Key Dates

Recruitment Start Date

Jul 2011

Recruitment End Date

Jan 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

01 Jul 2011

Date updated in source

20 Jan 2016