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Nitric Oxide in Myocardial Infarction Size (NOMI)
This study has been terminated.
( Slow Enrollment )
Study NCT00568061   Information provided by INO Therapeutics

First Received on December 3, 2007.   Last Updated on June 27, 2011   History of Changes
Results First Received: August 3, 2010  
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
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Recruitment Details
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Inhaled Nitric Oxide Inhaled Nitric Oxide administered at 80ppm
Nitrogen Gas Nitrogen Gas (Placebo) administered at 80ppm

Participant Flow:   Overall Study
    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
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Reporting Groups
  Description
Inhaled Nitric Oxide Inhaled Nitric Oxide administered at 80ppm
Nitrogen Gas Nitrogen Gas (Placebo) administered at 80ppm

Baseline Measures
    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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   MI Size Normalized to Area at Risk   [ Time Frame: 48-72 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Myocardial Perfusion at Coronary Angiography   [ Time Frame: at completion of PCI ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Infarct Transmurality   [ Time Frame: 48-72 hours and 4 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Global & Regional LV Function and LV Mass   [ Time Frame: 48-72 hours and 4 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Change in Global LV Function and Mass   [ Time Frame: between 48-72 hours and 4 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   MI Size as a Fraction of LV Size   [ Time Frame: 4 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Resolution of ST Segment Elevation Compared With That Observed at Enrollment   [ Time Frame: 4 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Troponin T Levels and CPK-MB Area Under the Curve   [ Time Frame: 48 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
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 and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: James Baldassarre, MD
Organization: INO Therapeutics LLC
phone: 908-238-6603
e-mail: james.baldassarre@ikaria.com


No publications provided


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