| December 3, 2007 |
| September 23, 2008 |
| June 2006 |
| June 2008 (final data collection date for primary outcome measure) |
| 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 [ Time Frame: 48-72 hours ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00568061 on ClinicalTrials.gov Archive Site |
- MI size at 48-72 hours [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
- MI size normalized to area at risk [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
- myocardial perfusion at coronary angiography [ Time Frame: at completion of PCI ] [ Designated as safety issue: No ]
- Infarct transmurality [ Time Frame: 48-72 hours and 4 months ] [ Designated as safety issue: No ]
- global & regional LV function and LV mass [ Time Frame: 48-72 hours and 4 months ] [ Designated as safety issue: No ]
- change in global LV function and mass [ Time Frame: between 48-72 hours and 4 months ] [ Designated as safety issue: No ]
- MI size as a fraction of LV size [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Resolution of ST segment elevation compared with that observed at enrollment [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- Troponin T levels and CPK-MB area under the curve [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 4 months ] [ Designated as safety issue: No ]
|
| MI size at 48-72 hours, size normalized to area at risk at 48-72 hours, myocardial perfusion at coronary angiography at the completion of PCI, Infarct transmurality, Myocardial perfusion at 48-72 hours and 4 months, Global & regional left LV function [ Time Frame: 48-72 hours and 4 months ] [ Designated as safety issue: Yes ] |
| |
| Nitric Oxide in Myocardial Infarction Size |
| The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size |
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 who undergo successful percutaneous coronary intervention. |
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. |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
- Acute Myocardial Infarction
- ST Elevation MI
- STEMI
|
| Drug: nitric oxide for inhalation |
| |
| |
| |
| Terminated |
| 29 |
| June 2008 |
| June 2008 (final data collection date for primary outcome measure) |
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 TIMI 0 or 1 coronary flow with resulting TIMI 2 or 3 flow
- Greater than 18 years of age
- Signed IRB approved informed consent
Exclusion Criteria:
- Prior myocardial infarction
- Requirement for urgent cardiac surgery
- Previous CABG or 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 60ml/min/1.73m² 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
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Belgium, Canada |
| |
| NCT00568061 |
| Rob Small, INO Therapeutics |
| INOT 44 |
| INO Therapeutics |
|
| Study Director: |
James Baldassarre, MD |
INO Therapeutics |
|
|
| INO Therapeutics |
| September 2008 |