Nitric Oxide in Myocardial Infarction Size

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Acute Myocardial Infarction, ST Elevation MI, STEMI

In brief

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.

Key facts

Study ID

NCT00568061

Run by

Mallinckrodt

People needed

29

Starts

2006-06-01

Expected to finish

2008-06-01

Last updated by the study team

2019-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Providence Hospital — Mobile, Alabama, United States
• Baptist Cardiac & Vascula Institute — Miami, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• University of Kansas Hospital — Kansas City, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Jack D. Weiler Hospital — The Bronx, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• LeBauer Cardiology — Greensboro, North Carolina, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• UPMC Cardiovascular Institute — Pittsburgh, Pennsylvania, United States
• Central Utah Imaging — Provo, Utah, United States
• Virga Jesse Hospital — Hasselt, Belgium
• University of Alberta Hospital — Edmonton, Alberta, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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