Nitrites in Acute Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)?"

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Effectiveness of Intra-coronary Nitrite in Acute Myocardial Infarction

NCT01584453

Myocardial Infarction Reperfusion Injury Myocardial Ischemia +1 more

COMPLETED PHASE2

Effects of Nitric Oxide for Inhalation in Myocardial Infarction Size

NCT01398384

Acute Myocardial Infarction

COMPLETED PHASE2

Nitric Oxide in Myocardial Infarction Size

NCT00568061

Acute Myocardial Infarction ST Elevation MI STEMI

TERMINATED PHASE2

Early Mineralocorticoid Receptor Antagonist Treatment to Reduce Myocardial Infarct Size

NCT01882179

ST-elevation Myocardial Infarction

COMPLETED PHASE3

Safety of Nitroglycerin for Field Treatment of STEMI

NCT02407002

Myocardial Infarction

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Acute ST Elevation Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

sodium nitrite

Group Type EXPERIMENTAL

sodium nitrite

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No