Acute Myocardial Infarction Clinical Trial
— NOMIOfficial title:
The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size
NCT number | NCT00568061 |
Other study ID # | INOT 44 |
Secondary ID | |
Status | Terminated |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2006 |
Est. completion date | June 2008 |
Verified date | May 2016 |
Source | Mallinckrodt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 29 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Virga Jesse Hospital | Hasselt | |
Canada | University of Alberta Hospital | Edmonton | Alberta |
Canada | St. Michael's Hospital | Toronto | Ontario |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Jack D. Weiler Hospital | Bronx | New York |
United States | Montefiore Medical Center | Bronx | New York |
United States | Northwestern University | Chicago | Illinois |
United States | LeBauer Cardiology | Greensboro | North Carolina |
United States | University of Kansas Hospital | Kansas City | Kansas |
United States | Baptist Cardiac & Vascula Institute | Miami | Florida |
United States | Providence Hospital | Mobile | Alabama |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | UPMC Cardiovascular Institute | Pittsburgh | Pennsylvania |
United States | Central Utah Imaging | Provo | Utah |
Lead Sponsor | Collaborator |
---|---|
Mallinckrodt |
United States, Belgium, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size | The primary endpoint - mean percent of the myocardial infarction size to the fraction of left ventricular size at 48-72 hours was measured by contrast-enhanced cardiac Magnetic Resonance Imaging (MRI). | 48-72 hours | |
Secondary | Myocardial Infarction (MI) Size at 48-72 Hours | 48-72 hours | ||
Secondary | MI Size Normalized to Area at Risk | 48-72 hours | ||
Secondary | Myocardial Perfusion at Coronary Angiography | at completion of primary coronary intervention (PCI) | ||
Secondary | Infarct Transmurality | 48-72 hours and 4 months | ||
Secondary | Global & Regional Left Ventricular (LV) Function and LV Mass | 48-72 hours and 4 months | ||
Secondary | Change in Global LV Function and Mass | between 48-72 hours and 4 months | ||
Secondary | MI Size as a Fraction of LV Size | 4 months | ||
Secondary | Resolution of ST Segment Elevation Compared With That Observed at Enrollment | 4 hours | ||
Secondary | Troponin T Levels and CPK-MB Area Under the Curve | 48 hours | ||
Secondary | 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 | 4 months |
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