Back to results

Nitrites in Acute Myocardial Infarction (NIAMI)

Primary Purpose

Acute ST Elevation Myocardial Infarction

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

sodium nitrite

Placebo

About this trial

This is an interventional treatment trial for Acute ST Elevation Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Aberdeen Royal Infirmary
Brighton and Sussex University Hospitals NHS Trust
St George's Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

sodium nitrite

placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Infarct size corrected for area at risk (using ESA)

Secondary Outcome Measures

Left ventricular ejection fraction and end systolic volume index

Plasma creatine kinase

Troponin I

Infarct size corrected for area at risk

Infarct size corrected for area at risk (using T2)

Full Information

NCT ID

NCT01388504

First Posted

July 1, 2011

Last Updated

January 20, 2016

Sponsor

University of Aberdeen

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

1. Study Identification

Unique Protocol Identification Number

NCT01388504

Brief Title

Nitrites in Acute Myocardial Infarction

Acronym

NIAMI

Official Title

Does Sodium Nitrite Administration Reduce Ischaemia-reperfusion Injury in Patients Presenting With Acute ST Segment Elevation Myocardial Infarction?

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aberdeen

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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)?"

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute ST Elevation Myocardial Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sodium nitrite

Arm Type

Experimental

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

sodium nitrite

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Infarct size corrected for area at risk (using ESA)

Time Frame

6-8 days post injection

Secondary Outcome Measure Information:

Title

Left ventricular ejection fraction and end systolic volume index

Time Frame

6-8 days and 6 months post injection

Title

Plasma creatine kinase

Time Frame

72 hours post injection

Title

Troponin I

Time Frame

72 hours post injection

Title

Infarct size corrected for area at risk

Time Frame

6 months

Title

Infarct size corrected for area at risk (using T2)

Time Frame

6-8 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Frenneaux, MD, FRCP

Organizational Affiliation

University of Aberdeen

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Juan Carlos Kaski, MD, FRCP

Organizational Affiliation

St George's Healthcare NHS Trust

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David HildickSmith, MD, FRCP

Organizational Affiliation

Brighton and Sussex University Hospitals NHS Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aberdeen Royal Infirmary

City

Aberdeen

ZIP/Postal Code

AB25 2ZD

Country

United Kingdom

Facility Name

Brighton and Sussex University Hospitals NHS Trust

City

Brighton

Country

United Kingdom

Facility Name

St George's Healthcare NHS Trust

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

23648219

Citation

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.

Results Reference

derived

Learn more about this trial

Nitrites in Acute Myocardial Infarction

We'll reach out to this number within 24 hrs