The effects of Nitric Oxide for Inhalation on MYocardial Infarction Size

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 200

Inclusion Criteria

1. Acute myocardial infarction (defined as an episode of chest pain or
related symptom lasting greater than 2 hours but less than 12 hours and
electrocardiographic evidence of ST elevation (measured as 0.08 seconds after the J point; sum ? 0.6 mV in leads I, II, III, AVL, AVF, V1-
V6).
2. No evidence of congestive heart failure (no S3 or evidence of
pulmonary edema) and normal oxygen saturation on = 2L oxygen by NC.
3. All patients must undergo successful percutaneous coronary
intervention for TIMI 0 or 1 coronary flow with resulting TIMI 2 or 3
(residual stenosis less than 30% if stented and less than 50% if opened
by balloon angioplasty).
4. Age > 18 years.
5. Signed EC approved informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Prior myocardial infarction (as determined by patient history and/or
ECG), cardiac surgery, or severe pericardial, congenital, cardiomyopathic
or valvular heart disease.
2. Requirement for urgent cardiac surgery.
3. Previous CABG or PCI.
4. Left bundle branch block.
5. Unable to tolerate magnetic resonance imaging (including disallowed
metallic implants or BMI > 35) or unable to tolerate gadolinium contrast
media, including patients with calculated creatinine clearance less than
60 ml/min/1.73 m2 BSA.
6. Active or recent hemorrhage requiring an invasive procedure for
evaluation or transfusion within 6 weeks prior to presentation or
hemorrhagic stroke within the 6 weeks prior to presentation.
7. Known or suspected aortic dissection.
8. Prior history of pulmonary disease requiring chronic oxygen therapy.
9. Pregnancy, lactating and woman of childbearing potential.
10. Use of investigational drugs or device within the 30 days prior to
enrollment to the study. Investigational uses of approved therapies will
be allowed.
11. Medical problem likely to preclude completion of the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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