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Nitrites in Acute Myocardial Infarction

NCT01388504 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-01-21

No results posted yet for this study

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)?"

Conditions

  • Acute ST Elevation Myocardial Infarction

Interventions

DRUG

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

OTHER

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

Sponsors & Collaborators

  • NHS Grampian

    collaborator OTHER_GOV

  • Medical Research Council

    collaborator OTHER_GOV

  • St George's Healthcare NHS Trust

    collaborator OTHER

  • Brighton and Sussex University Hospitals NHS Trust

    collaborator OTHER

  • Imperial College London

    collaborator OTHER

  • University of Birmingham

    collaborator OTHER

  • University of Aberdeen

    lead OTHER

Principal Investigators

  • Michael Frenneaux, MD, FRCP · University of Aberdeen

  • Juan Carlos Kaski, MD, FRCP · St George's Healthcare NHS Trust

  • David HildickSmith, MD, FRCP · Brighton and Sussex University Hospitals NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01388504 on ClinicalTrials.gov