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IMMEDIATE Trial - Out of Hospital Administration of Glucose, Insulin and Potassium.

This study has been completed.
Sponsor:
Collaborator:
Tufts Medical Center
Information provided by (Responsible Party):
Joni Beshansky, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00091507
First received: September 9, 2004
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
Results First Received: November 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Angina, Unstable
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Myocardial Infarction
Heart Failure, Congestive
Interventions: Drug: GIK
Drug: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
GIK -- GIK = glucose-insulin-potassium
Placebo Dextrose 5%

Participant Flow:   Overall Study
    GIK --     Placebo  
STARTED     432     479  
COMPLETED     411     460  
NOT COMPLETED     21     19  



  Baseline Characteristics
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Reporting Groups
  Description
GIK -- GIK = glucose-insulin-potassium
Placebo Dextrose 5%
Total Total of all reporting groups

Baseline Measures
    GIK --     Placebo     Total  
Number of Participants  
[units: participants]
 		  432     479     911  
Age  
[units: years]
Mean ± Standard Deviation 		  63.9  ± 13.9     63.3  ± 14.1     63.6  ± 14.0  
Gender  
[units: participants]
 		     
Female     119     146     265  
Male     313     333     646  
Region of Enrollment  
[units: participants]
 		     
United States     432     479     911  



  Outcome Measures
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1.  Primary:   Progression of Acute Coronary Syndrome to Myocardial Infarction   [ Time Frame: 24 hours ]
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2.  Secondary:   Cardiac Arrest   [ Time Frame: From prehospital through hospitalization. ]
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3.  Secondary:   Heart Failure or Death   [ Time Frame: 30 days ]
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4.  Secondary:   Mortality   [ Time Frame: 30 days ]
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5.  Secondary:   Cardiac Arrest or Acute Mortality   [ Time Frame: Prehospital setting through hospitalization ]
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  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
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Results Point of Contact:  
Name/Title: Co-Principal Investigator
Organization: Tufts Medical Center
phone: 617-636-8788
e-mail: jbeshansky@tuftsmedicalcenter.org


Publications of Results:

Other Publications:


Responsible Party: Joni Beshansky, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00091507     History of Changes
Other Study ID Numbers: 165, U01HL077821, U01HL077822, U01HL077823, U01HL077826
Study First Received: September 9, 2004
Results First Received: November 13, 2012
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration