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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment |
| Conditions: |
Acute Myocardial Infarction ST Elevation MI STEMI |
| Intervention: |
Drug: nitric oxide for inhalation |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 7 medical centers enrolled subjects. A total of 29 subjects were enrolled in the study. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
| Description | |
|---|---|
| Inhaled Nitric Oxide | Inhaled Nitric Oxide administered at 80ppm |
| Nitrogen Gas | Nitrogen Gas (Placebo) administered at 80ppm |
| Inhaled Nitric Oxide | Nitrogen Gas | |
|---|---|---|
| STARTED | 13 | 16 |
| COMPLETED | 8 | 14 |
| NOT COMPLETED | 5 | 2 |
| Inclusion / exclusion criteria | 5 | 1 |
| Adverse Event | 0 | 1 |
Baseline Characteristics
| Description | |
|---|---|
| Inhaled Nitric Oxide | Inhaled Nitric Oxide administered at 80ppm |
| Nitrogen Gas | Nitrogen Gas (Placebo) administered at 80ppm |
| Inhaled Nitric Oxide | Nitrogen Gas | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
13 | 16 | 29 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 16 | 29 |
| >=65 years | 0 | 0 | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
62.3 ± 11.71 | 63.8 ± 12.41 | 63.1 ± 11.91 |
|
Gender
[units: participants] |
|||
| Female | 5 | 3 | 8 |
| Male | 8 | 13 | 21 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 13 | 16 | 29 |
Outcome Measures
| 1. Primary: | Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size [ Time Frame: 48-72 hours ] |
| 2. Secondary: | MI Size at 48-72 Hours [ Time Frame: 48-72 hours ] |
| 3. Secondary: | MI Size Normalized to Area at Risk [ Time Frame: 48-72 hours ] |
| 4. Secondary: | Myocardial Perfusion at Coronary Angiography [ Time Frame: at completion of PCI ] |
| 5. Secondary: | Infarct Transmurality [ Time Frame: 48-72 hours and 4 months ] |
| 6. Secondary: | Global & Regional LV Function and LV Mass [ Time Frame: 48-72 hours and 4 months ] |
| 7. Secondary: | Change in Global LV Function and Mass [ Time Frame: between 48-72 hours and 4 months ] |
| 8. Secondary: | MI Size as a Fraction of LV Size [ Time Frame: 4 months ] |
| 9. Secondary: | Resolution of ST Segment Elevation Compared With That Observed at Enrollment [ Time Frame: 4 hours ] |
| 10. Secondary: | Troponin T Levels and CPK-MB Area Under the Curve [ Time Frame: 48 hours ] |
| 11. 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 [ Time Frame: 4 months ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| No text entered. |
| Responsible Party: | Rob Small, INO Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00568061 History of Changes |
| Other Study ID Numbers: | INOT 44 |
| Study First Received: | December 3, 2007 |
| Results First Received: | August 3, 2010 |
| Last Updated: | June 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |