Nitric Oxide in Myocardial Infarction Size

• Status: Terminated
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Nitric Oxide

Criteria

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