Clinical trial NCT00568061: Nitric Oxide in Myocardial Infarction Size
Official title: The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Myocardial Infarction
ST Elevation MI
STEMI
Keywords: INOT44
NOMI
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size
timeFrame: 48-72 hours
Secondary outcomes:
measure: Myocardial Infarction (MI) Size at 48-72 Hours
timeFrame: 48-72 hours
measure: MI Size Normalized to Area at Risk
timeFrame: 48-72 hours
measure: Myocardial Perfusion at Coronary Angiography
timeFrame: at completion of primary coronary intervention (PCI)
measure: Infarct Transmurality
timeFrame: 48-72 hours and 4 months
measure: Global & Regional Left Ventricular (LV) Function and LV Mass
timeFrame: 48-72 hours and 4 months
measure: Change in Global LV Function and Mass
timeFrame: between 48-72 hours and 4 months
measure: MI Size as a Fraction of LV Size
timeFrame: 4 months
measure: Resolution of ST Segment Elevation Compared With That Observed at Enrollment
timeFrame: 4 hours
measure: Troponin T Levels and CPK-MB Area Under the Curve
timeFrame: 48 hours
measure: Change in Adverse Remodeling Parameters Compared With 48-72 Hrs: Changes in LV End-diastolic Vol, End-systolic Vol, End-diastolic Myocardial Wall Thickness in Infarct, Peri-infarct and Remote Areas, and in Sphericity Index at End-diastole and End-systole
timeFrame: 4 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Providence Hospital
state: Alabama
city: Miami
country: United States
facility: Baptist Cardiac & Vascula Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Bronx
country: United States
facility: Jack D. Weiler Hospital
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Greensboro
country: United States
facility: LeBauer Cardiology
state: North Carolina
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cardiovascular Institute
state: Pennsylvania
city: Provo
country: United States
facility: Central Utah Imaging
state: Utah
city: Hasselt
country: Belgium
facility: Virga Jesse Hospital
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Mallinckrodt
name: James Baldassarre, MD
role: STUDY_DIRECTOR
References: