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Sodium Nitrite in Acute Myocardial Infarction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00924118
First Posted: June 18, 2009
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hope Pharmaceuticals
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: July 28, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Acute Myocardial Infarction
Intervention: Drug: Sodium Nitrite

  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
No text entered.

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
Sodium Nitrite

Dose escalation of sodium nitrite.

Sodium Nitrite: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects.

Open Control Subjects randomized to open control will receive no experimental therapy.

Participant Flow:   Overall Study
    Sodium Nitrite   Open Control
STARTED   15   15 
COMPLETED   15   15 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sodium Nitrite

Dose escalation of sodium nitrite.

Sodium Nitrite: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects.

Open Control Subjects randomized to open control will receive no experimental therapy.
Total Total of all reporting groups

Baseline Measures
   Sodium Nitrite   Open Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   15   30 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      12  80.0%      11  73.3%      23  76.7% 
>=65 years      3  20.0%      4  26.7%      7  23.3% 
Age 
[Units: Years]
Mean (Full Range)
 59.6 
 (44 to 76) 
 59.2 
 (46 to 72) 
 59.4 
 (44 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  26.7%      1   6.7%      5  16.7% 
Male      11  73.3%      14  93.3%      25  83.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   15   15   30 


  Outcome Measures
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1.  Primary:   Primary Efficacy Outcome is a to Determine Whether Sodium Nitrite Safely Reduces Infarct Size Normalized for the Ischemia Area at Risk as Determined by Paired Single-photon Computed Tomography Studies With Technetium Tc99m Sestamibi.   [ Time Frame: 4-5 days from enrollment ]

2.  Secondary:   Left Ventricular Infarct Size   [ Time Frame: 4-5 days following enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The primary and secondary outcomes of this study were limited by too few subjects undergoing these studies.


  More Information