Condition category
Circulatory System
Date applied
18/01/2013
Date assigned
23/01/2013
Last edited
04/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anthony Mathur

ORCID ID

Contact details

London Chest Hospital
Victoria Park Site
Bonner Road
London
E2 9JX
United Kingdom
a.mathur@qmul.ac.uk

Additional identifiers

EudraCT number

2011-000721-77

ClinicalTrials.gov number

Protocol/serial number

12117

Study information

Scientific title

Acronym

NITRITE-AMI

Study hypothesis

Despite advances in the treatment of heart attacks such as reopening of the blocked artery (primary angioplasty), the complications and death rates from failure of the heart to pump adequately remain high. The size of the heart attack is the major determinant of these adverse outcomes. Whilst reopening the artery allows blood to flow to the area of the heart starved of oxygen, this process also causes damage itself (“reperfusion injury”) and increases the size of the heart attack.

It has been shown that nitrite protects against reperfusion injury in models of heart attack. We will therefore perform a trial to investigate whether during a heart attack, an infusion of nitrite into the damaged artery protects against reperfusion injury and reduces heart attack size.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12117

Ethics approval

Committee:- NRES Committee London-West London, 08 November 2011, REC reference: 11/LO/1500

Study design

Randomised single centre double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Atherothrombosis

Intervention

Sodium Chloride, Placebo
10mls Intra-coronary at time of PPCI; Sodium Nitrite, Study IMP
10mls 1.8% intra-coronary during PPCI

The experimental intervention is a bolus of sodium nitrite solution (1.8 micromol in 10 ml (pre-diluted in 0.9% sodium chloride in a syringe) which will be delivered over 30 seconds via intracoronary injection initiated during the re-establishment of antegrade epicardial flow with PPCI.

The control intervention is a bolus of 0.9% sodium chloride solution (prepared with an identical appearance to the sodium nitrite).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Creatine Kinase AUC first 48 hours after PPCI

Secondary outcome measures

1. Infarct size on CMR; Timepoint(s): 48 hours and 6 months
2. Myocardial salvage index (MSI) on CMR; Timepoint(s): 48 hours
3. Troponin T AUC; Timepoint(s): 1st 48 hours after PPCI

Overall trial start date

10/04/2012

Overall trial end date

10/02/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged at least 18 years, upper age limit 80 years, male and female
2. Acute ST-elevation myocardial infarction with ECG showing at least 2 mm of ST segment elevation in 2 or more limb leads or 1mm in 2 or more contiguous chest leads, or new left bundle branch block
3. Haemodynamically stable
4. Estimated symptom to balloon or aspiration time < 6 hours
5. A signed and dated written informed consent prior to admission to the study
6. Angiographicallly
6.1. Primary Percutaneous Coronary Intervention (PPCI) indicated for revascularisation
6.2. Single epicardial artery to be treated
6.3. Expected ability to use the over the wire balloon for delivery of nitrite

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 80

Participant exclusion criteria

1. Patients already on nitrate Treatment (Nicorandil, ISMN)
2. Previous history of myocardial infarction (MI) or systolic dysfunction
3. Previous coronary artery bypass surgery (CABG)
4. Subjects presenting with cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring inotropes or emergency IntraAortic
Balloon Pump (IABP) for hypotension treatment) or cardiopulmonary resuscitation
5. Current diagnosis of or treatment for malignancy, other than non-melanoma skin cancer
6. Current life-threatening condition other than vascular disease that may prevent a subject completing the study
7. Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication
8. Patients considered unsuitable to participate by the research team (e.g., due to medical reasons, laboratory abnormalities, or subject’s unwillingness to comply with all study-related procedures)
9. Severe acute infection, or significant trauma (burns, fractures)
10. Pregnancy
11. Contraindications tocardiac magnetic resonance (CMR) scanning
11.1. Pacemakers, intracranial clips or other metal implants or foreign bodies
11.2. Claustrophobia
11.3. Renal Failure (eGFR<30mls/min)
12. History of alcohol or drug abuse within the past 6 months
13. History of congenital methaemoglobinaemia
14. Angiographically
14.1. Severe vessel tortuosity, diffuse disease or severe calcification is present which may impede successful delivery of the over the wire balloon

Recruitment start date

10/04/2012

Recruitment end date

10/02/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

London Chest Hospital
London
E2 9JX
United Kingdom

Sponsor information

Organisation

Barts and The London NHS Trust (UK)

Sponsor details

Joint Research Office
24-26 Walden Street
London
E1 2AN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.bartsandthelondon.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR (UK) - Doctoral Research Fellowship; Grant Codes: NIHR-DRF-2011-04-080

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23550096

Publication citations

  1. Protocol

    Jones DA, Andiapen M, Van-Eijl TJ, Webb AJ, Antoniou S, Schilling RJ, Ahluwalia A, Mathur A, The safety and efficacy of intracoronary nitrite infusion during acute myocardial infarction (NITRITE-AMI): study protocol of a randomised controlled trial., BMJ Open, 2013, 3, 4, doi: 10.1136/bmjopen-2013-002813.

Additional files

Editorial Notes