Does nitrite reduce ischaemia-reperfusion injury in patients with acute ST segment elevation myocaridal infarction? - NIAMI - Nitrites in Acute Myocardial Infarction

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023571-26-GB

Enrollment

200

Registered

2011-01-10

Start date

2011-03-03

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Interventions

Product Name: Sodium Nitrite dissolved in water Pharmaceutical Form: Solution for injection INN or Proposed INN: Sodium Nitrite CAS Number: 7632-00-0

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men aged >=18 years and women aged >=55 years presenting within 12 hours of the onset of chest pain who have ST segment elevation of more than 0.1mV 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 grade 1) will also be required for inclusion. Eligible patients will be of North European descent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: The exclusion criteria are: Historical or ECG evidence of previous myocardial infarction Prior revascularization procedure Known or suspected pregnancy Atrial fibrillation at time of randomization 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: In patients who have had a heart attack and are undergoing percutanuous coronary intervention (angioplasty), does a 5 minute intravenous injection of sodium nitrite immediately prior to opening of an infarct related artery reduce the size of the infarct (ie reduce the amount of damage caused to the heart)?;Secondary Objective: There are no secondary research questions.;Primary end point(s): The primary outcome measure is final infarct size measured using MRI scan between 10-14 days following the infusion (and corrected for area at risk)	—

Measure

Time frame

Main Objective: In patients who have had a heart attack and are undergoing percutanuous coronary intervention (angioplasty), does a 5 minute intravenous injection of sodium nitrite immediately prior to opening of an infarct related artery reduce the size of the infarct (ie reduce the amount of damage caused to the heart)?;Secondary Objective: There are no secondary research questions.;Primary end point(s): The primary outcome measure is final infarct size measured using MRI scan between 10-14 days following the infusion (and corrected for area at risk)

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026