Acute ST Elevation Myocardial InfarctionPhase 2/3NIAMINCT01388504
Nitrites in Acute Myocardial Infarction
A Phase 2/3 study testing sodium nitrite in people with Acute ST Elevation Myocardial Infarction, run by University of Aberdeen at 3 sites in United Kingdom.
Trial 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)?" Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute ST Elevation Myocardial Infarction
- What is being tested?
- sodium nitrite
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jul 2011to Jan 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
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- 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).
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZD
Brighton and Sussex University Hospitals NHS Trust
Brighton
St George's Healthcare NHS Trust
London, SW17 0QT
About this study
Official title: Does Sodium Nitrite Administration Reduce Ischaemia-reperfusion Injury in Patients Presenting With Acute ST Segment Elevation Myocardial Infarction?
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)?"
Read the 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.
- Conditions
- Acute ST Elevation Myocardial Infarction
- Being tested
- sodium nitrite, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium nitriteDrug
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
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| sodium nitrite | Experimental | Not described Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size corrected for area at risk (using ESA)
Measured: 6-8 days post injection
Secondary outcomes (5)
Left ventricular ejection fraction and end systolic volume index
Measured: 6-8 days and 6 months post injection
Plasma creatine kinase
Measured: 72 hours post injection
Troponin I
Measured: 72 hours post injection
Infarct size corrected for area at risk
Measured: 6 months
Infarct size corrected for area at risk (using T2)
Measured: 6-8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Michael Frenneaux, MD, FRCP, Study director, University of AberdeenJuan Carlos Kaski, MD, FRCP, Principal investigator, St George's Healthcare NHS TrustDavid HildickSmith, MD, FRCP, Principal investigator, Brighton and Sussex University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388504
- Sponsor's protocol ID
- 3/030/10
- Acronym
- NIAMI
- Status last verified
- Nov 2015
- First submitted
- 1 Jul 2011
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23648219
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Sodium Nitrite Administration Reduce Ischaemia-reperfusion Injury in Patients Presenting With Acute ST Segment Elevation Myocardial Infarction?
- ClinicalTrials.gov ID
- NCT01388504
- Acronym / sponsor ID
- NIAMI / 3/030/10
- Conditions
- Acute ST Elevation Myocardial Infarction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- 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
- Study start
- Jul 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sodium nitrite | Experimental | Drug: sodium nitrite |
| placebo | Placebo comparator | Other: Placebosterile solution containing 0.9%w/v sodium chloride in 5ml water injected intravenously over a period of 2½ - 5 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium nitritesterile 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 | Drug | sodium nitrite |
| Placebosterile 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 | Other | placebo |
Primary outcome
Infarct size corrected for area at risk (using ESA)
Time frame: 6-8 days post injection
5 secondary outcomes
Left ventricular ejection fraction and end systolic volume index
Time frame: 6-8 days and 6 months post injection
Plasma creatine kinase
Time frame: 72 hours post injection
Troponin I
Time frame: 72 hours post injection
Infarct size corrected for area at risk
Time frame: 6 months
Infarct size corrected for area at risk (using T2)
Time frame: 6-8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
- Derived from this study: PubMed 23648219Siddiqi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Frenneaux, MD, FRCP study director
University of Aberdeen
Juan Carlos Kaski, MD, FRCP principal investigator
St George's Healthcare NHS Trust
David HildickSmith, MD, FRCP principal investigator
Brighton and Sussex University Hospitals NHS Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing sodium nitrite in people with Acute ST Elevation Myocardial Infarction, run by University of Aberdeen at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct size corrected for area at risk (using ESA) (time frame: 6-8 days post injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01388504, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2016.