COMPARISON OF HIGH FLOW VERSUS TITRATED OXYGEN THERAPY IN THE ACUTEMANAGEMENT OF ST ELEVATION MYOCARDIAL INFARCTION - The Oxygen in Myocardial Infarction Study

• Conditions: Acute myocardial infarction; MedDRA version: 9.1Level: LLTClassification code 10000891Term: Acute myocardial infarction

• Registration Number: EUCTR2007-002481-35-GB
• Lead Sponsor: niversity Hospital of South Manchester NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Subjects are eligible to be included in the study if they meet all of the following criteria:

(1)Present with ST-Elevation Myocardial Infarction based on the disease diagnostic criteria (see below)

(2)Are at least 18 years of age and competent to provide written informed consent before entering the study. Informed consent must be signed by the study participant.

Disease Diagnostic Criteria

For the purposes of this study, STEMI will include:

A history of chest discomfort or ischaemic symptoms of > 20 minutes duration, < 12 hours prior to randomisation and one of the following present on at least one ECG prior to randomisation

•ST-segment elevation > 1mm in two or more contiguous limb leads or > 2mm in two or more precordial leads.

•New or presumably new left bundle branch block (LBBB)

•ST-segment depression > 1mm in two anterior precordial leads (V1 through V4) with clinical history and evidence suggestive of true posterior infarction.

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

4.3 Exclusion Criteria

(1)Severe Chronic Obstructive Pulmonary Disease (COPD)
(2)Known previous myocardial infarction or CABG; Q waves on ECG in territory other than that of presentation myocardial infarction
(3) Previous bleomycin treatment
(4)Subjects who are not to be admitted to the coronary care unit.
(5)Participants who are immediate family members of investigator site personnel directly affiliated with study, whether biological or legally adopted.
(6)Women who are known to be pregnant
(7)Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
(8)Cardiogenic shock (systolic blood pressure less than 90 mm Hg lasting more than 30 mins with evidence of tissue hypoperfusion as defined as cold peripheries (extremities colder than core), oliguria (<30 mL/h), or both) at the time of presentation to the emergency department
(9)Severe arterial hypoxaemia (oxygen saturation =85%) at time of presentation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study is a pilot towards testing the hypothesis that high flow oxygen in the routine management of ST elevation myocardial infarction (STEMI) is harmful as measured by the risk of death, complications and infarct size.<br><br>Endpoints: <br>•Mortality at 30 days<br>•30 day major adverse cardiac events (MACE)<br>•Infarct size measured by Troponin T, Brain Natriuretic peptide (BNP) level and Magnetic Resonance Imaging (MRI) <br>;Secondary Objective: ;Primary end point(s): Endpoints: <br>•Mortality at 30 days<br>•30 day major adverse cardiac events (MACE)<br>•Infarct size measured by troponin T, BNP level and MRI <br><br>The study will be used as a pilot for a large multicentre study of the effect of the routine use of high flow oxygen in myocardial infarction.<br>