Nitric Oxide in Myocardial Infarction Size (NOMI)

Mallinckrodt

Status and phase

Terminated

Phase 2

Conditions

ST Elevation MI

STEMI

Acute Myocardial Infarction

Treatments

Drug: Placebo

Drug: Nitric Oxide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00568061

INOT 44

Details and patient eligibility

About

The purpose of this study is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size at 48-72 hours in patients presenting with an ST segment elevation MI (STEMI) who undergo successful percutaneous coronary intervention.

Full description

The purpose of the trial is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size as a fraction of left ventricular (LV) size at 48-72 hours in patients presenting with an ST segment elevation MI who undergo successful percutaneous coronary intervention (PCI).

The primary endpoint for this study will be myocardial infarction size as a fraction of left ventricular size at 48-72 hours as measured by contrast-enhanced cardiac MRI.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Acute myocardial infarction and electrocardiographic evidence of ST elevation
No clinical evidence of congestive heart failure
All patients must undergo successful percutaneous coronary intervention for thrombolysis in myocardial infarction (TIMI) 0 or 1 coronary flow with resulting TIMI 2 or 3 flow
Greater than 18 years of age
Signed Institutional Review Board (IRB) approved informed consent

Exclusion criteria

Prior myocardial infarction
Requirement for urgent cardiac surgery
Previous coronary artery bypass graft (CABG) or primary coronary intervention (PCI)
Left bundle branch block
Heart block that is expected to require a temporary pacemaker for greater than 72 hours
Prior use of thrombolytic therapy for the current event
Unable to tolerate magnetic resonance imaging or unable to tolerate gadolinium contrast media, including patients with a calculated creatinine clearance less than 60 ml/min/1.73m² Body Surface Area (BSA)
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
Neutropenia (WBC <2000 (mm)³), Anemia (HCT <30%, Thrombocytopenia (Thrombocytes <50,000 (mm)³). It is not necessary to confirm blood counts prior to start of study drug in the absence of clinical suspicion.
Known or suspected aortic dissection.
Prior history of pulmonary disease requiring chronic oxygen therapy.
Pregnancy, lactating, and women of childbearing potential.
Medical problem likely to preclude completion of the study.
Use of investigational drugs or device within the 30 days prior to enrollment