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Slow Enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Nitric Oxide | Experimental | Inhaled Nitric oxide administered at 80 parts per million (ppm) |
|
| Placebo | Placebo Comparator | Inhaled nitrogen gas (Placebo) administered at 80 ppm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide | Drug | Nitric oxide for inhalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Infarction (MI) Size at 48-72 Hours | 48-72 hours | |
| MI Size Normalized to Area at Risk | 48-72 hours | |
| Myocardial Perfusion at Coronary Angiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Baldassarre, MD | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Hospital | Mobile | Alabama | 36608 | United States | ||
| Baptist Cardiac & Vascula Institute |
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7 medical centers enrolled subjects. A total of 29 subjects were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inhaled Nitric Oxide | Inhaled Nitric Oxide administered at 80 ppm |
| FG001 | Nitrogen Gas | Nitrogen Gas (Placebo) administered at 80 ppm |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhaled Nitric Oxide | Inhaled Nitric Oxide administered at 80ppm |
| BG001 | Nitrogen Gas | Nitrogen Gas (Placebo) administered at 80ppm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Analysis was per intent to treat population | Posted | Mean | Standard Deviation | percent of myocardial infarction size | 48-72 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inhaled Nitric Oxide | Inhaled Nitric Oxide administered at 80ppm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Embolism | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
The validated summary tables and CSR are not available for this legacy registration that was transferred to us eight years after it was terminated for low enrollment, so posting of results for secondary outcome measures is not possible.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt Pharmaceuticals | 800-556-3314 | clinicaltrials@mnk.com |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009569 | Nitric Oxide |
| D045462 | Endothelium-Dependent Relaxing Factors |
| D009584 | Nitrogen |
| ID | Term |
|---|---|
| D026361 | Reactive Nitrogen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009589 | Nitrogen Oxides |
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| Placebo | Drug | Nitrogen gas (placebo) for inhalation |
|
|
| at completion of primary coronary intervention (PCI) |
| Infarct Transmurality | 48-72 hours and 4 months |
| Global & Regional Left Ventricular (LV) Function and LV Mass | 48-72 hours and 4 months |
| Change in Global LV Function and Mass | between 48-72 hours and 4 months |
| MI Size as a Fraction of LV Size | 4 months |
| Resolution of ST Segment Elevation Compared With That Observed at Enrollment | 4 hours |
| Troponin T Levels and CPK-MB Area Under the Curve | 48 hours |
| 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 |
| Miami |
| Florida |
| 33176 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Jack D. Weiler Hospital | The Bronx | New York | 10467 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| LeBauer Cardiology | Greensboro | North Carolina | 27401 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| UPMC Cardiovascular Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| Central Utah Imaging | Provo | Utah | 84604 | United States |
| Virga Jesse Hospital | Hasselt | 3500 | Belgium |
| University of Alberta Hospital | Edmonton | Alberta | TGG 2B7 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Myocardial Infarction (MI) Size at 48-72 Hours | All efforts have been exhausted to locate data for this historical trial - the validated summary tables and Clinical Study Report (CSR) are no longer accessible. | Posted | 48-72 hours |
|
|
| Secondary | MI Size Normalized to Area at Risk | All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible. | Posted | 48-72 hours |
|
|
| Secondary | Myocardial Perfusion at Coronary Angiography | All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible. | Posted | at completion of primary coronary intervention (PCI) |
|
|
| Secondary | Infarct Transmurality | All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible. | Posted | 48-72 hours and 4 months |
|
|
| Secondary | Global & Regional Left Ventricular (LV) Function and LV Mass | All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible. | Posted | 48-72 hours and 4 months |
|
|
| Secondary | Change in Global LV Function and Mass | All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible. | Posted | between 48-72 hours and 4 months |
|
|
| Secondary | MI Size as a Fraction of LV Size | All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible. | Posted | 4 months |
|
|
| Secondary | Resolution of ST Segment Elevation Compared With That Observed at Enrollment | All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible. | Posted | 4 hours |
|
|
| Secondary | Troponin T Levels and CPK-MB Area Under the Curve | All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible. | Posted | 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 | All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible. | Posted | 4 months |
|
|
| 1 |
| 13 |
| 2 |
| 13 |
| EG001 | Nitrogen Gas | Nitrogen Gas (Placebo) administered at 80ppm | 1 | 16 | 1 | 16 |
| Retropertioneal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
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| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D017672 |
| Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |
| D014665 | Vasodilator Agents |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004602 | Elements |
| D005740 | Gases |