IMMEDIATE Trial - Out of Hospital Administration of Glucose, Insulin and Potassium.
IMMEDIATE
Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care Trial
5 other identifiers
interventional
911
1 country
13
Brief Summary
The purpose of this study is to test the impact of pharmacological myocardial metabolic support, in the form of intravenous (IV) glucose, insulin and potassium (GIK), for the treatment of patients with threatened or established acute myocardial infarction (AMI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2006
Longer than P75 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2004
CompletedFirst Posted
Study publicly available on registry
September 13, 2004
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
January 30, 2013
CompletedMarch 2, 2016
February 1, 2016
4.8 years
September 9, 2004
November 13, 2012
February 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression of Acute Coronary Syndrome to Myocardial Infarction
Outcome for all participants during the first 24 hours of hospitalization; evidence of myocardial infarction is determined by ECG and biomarker results.
24 hours
Secondary Outcomes (4)
Cardiac Arrest
1 to 18 hours (From prehospital setting through hospitalization.)
Heart Failure or Death
30 days
Mortality
30 days
Cardiac Arrest or Acute Mortality
Prehospital setting through hospitalization
Study Arms (2)
1 -- GIK
EXPERIMENTALGIK = glucose-insulin-potassium; In one-liter: Dextrose 30% + 80 mEq Potassium Chloride + 50 units Regular Insulin; infused at 1.5 ml/kg/hour for a total of 12 hours.
2 -- Placebo
PLACEBO COMPARATORDextrose 5%, infused at 1.5 ml/kg/hour for total of 12 hours.
Interventions
Eligibility Criteria
You may qualify if:
- Symptoms of threatened or established AMI including but not limited to:
- Chest pain, discomfort, or tightness
- Arm or shoulder pain
- Jaw pain
- Epigastric discomfort
- Shortness of breath
- lead electrocardiogram (ECG) with two or more contiguous leads with ST elevation greater than 1 mm, ST depression greater than 0.5 mm, T wave inversion or other T wave abnormalities (hyperacute T waves), or left bundle branch block (not known to be old). Identification aided by the acute cardiac ischemia time-insensitive predictive instrument (ACI-TIPI)and thrombolytic predictive instrument (TPI) decision support software (ACI-TIPI \>= 75% and TPI detection of suspected STEMI).
You may not qualify if:
- End-stage kidney failure requiring dialysis
- Rales present more than halfway up the back
- Unable to comply with the requirements of the study
- Incarcerated
- Known to be pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Anchorage Site
Anchorage, Alaska, 99501, United States
New Haven Site
New Haven, Connecticut, 06511, United States
Macon Site
Macon, Georgia, 31208, United States
Brockton Site
Brockton, Massachusetts, 02301, United States
Concord Site
Concord, Massachusetts, 01742, United States
St. Paul Site
Saint Paul, Minnesota, 55128, United States
Albuquerque Site
Albuquerque, New Mexico, 87131, United States
Hershey Site
Hershey, Pennsylvania, 17033, United States
Sioux Falls Site
Sioux Falls, South Dakota, 57104, United States
Dallas Site
Dallas, Texas, 75201, United States
El Paso Site
El Paso, Texas, 79905, United States
Bellingham Site
Bellingham, Washington, 98225, United States
Milwaukee Site
Milwaukee, Wisconsin, 53226, United States
Related Publications (10)
Selker HP, Beshansky JR, Ruthazer R, Sheehan PR, Sayah AJ, Atkins JM, Aufderheide TP, Pirrallo RG, D'Agostino RB, Massaro JM, Griffith JL. Emergency medical service predictive instrument-aided diagnosis and treatment of acute coronary syndromes and ST-segment elevation myocardial infarction in the IMMEDIATE trial. Prehosp Emerg Care. 2011 Apr-Jun;15(2):139-48. doi: 10.3109/10903127.2010.545478.
PMID: 21366431BACKGROUNDSelker HP, Beshansky JR, Griffith JL, D'Agostino RB, Massaro JM, Udelson JE, Rashba EJ, Ruthazer R, Sheehan PR, Desvigne-Nickens P, Rosenberg YD, Atkins JM, Sayah AJ, Aufderheide TP, Rackley CE, Opie LH, Lambrew CT, Cobb LA, Macleod BA, Ingwall JS, Zalenski RJ, Apstein CS. Study design for the Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care (IMMEDIATE) Trial: A double-blind randomized controlled trial of intravenous glucose, insulin, and potassium for acute coronary syndromes in emergency medical services. Am Heart J. 2012 Mar;163(3):315-22. doi: 10.1016/j.ahj.2012.02.002.
PMID: 22424000BACKGROUNDEllis KL, Zhou Y, Rodriguez-Murillo L, Beshansky JR, Ainehsazan E, Selker HP, Huggins GS, Cupples LA, Peter I. Common variants associated with changes in levels of circulating free fatty acids after administration of glucose-insulin-potassium (GIK) therapy in the IMMEDIATE trial. Pharmacogenomics J. 2017 Jan;17(1):76-83. doi: 10.1038/tpj.2015.84. Epub 2015 Dec 8.
PMID: 26644202BACKGROUNDEllis KL, Zhou Y, Beshansky JR, Ainehsazan E, Selker HP, Cupples LA, Huggins GS, Peter I. Genetic modifiers of response to glucose-insulin-potassium (GIK) infusion in acute coronary syndromes and associations with clinical outcomes in the IMMEDIATE trial. Pharmacogenomics J. 2015 Dec;15(6):488-95. doi: 10.1038/tpj.2015.10. Epub 2015 Mar 17.
PMID: 25778467BACKGROUNDAlkofide H, Huggins GS, Beshansky JR, Ruthazer R, Peter I, Ray M, Mukherjee JT, Selker HP. C-Reactive protein reactions to glucose-insulin-potassium infusion and relations to infarct size in patients with acute coronary syndromes. BMC Cardiovasc Disord. 2015 Dec 3;15:163. doi: 10.1186/s12872-015-0153-7.
PMID: 26631004BACKGROUNDAlkofide H, Huggins GS, Ruthazer R, Beshansky JR, Selker HP. Serum adiponectin levels in patients with acute coronary syndromes: Serial changes and relation to infarct size. Diab Vasc Dis Res. 2015 Nov;12(6):411-9. doi: 10.1177/1479164115592638. Epub 2015 Jul 20.
PMID: 26193887BACKGROUNDSelker HP, Beshansky JR, Sheehan PR, Massaro JM, Griffith JL, D'Agostino RB, Ruthazer R, Atkins JM, Sayah AJ, Levy MK, Richards ME, Aufderheide TP, Braude DA, Pirrallo RG, Doyle DD, Frascone RJ, Kosiak DJ, Leaming JM, Van Gelder CM, Walter GP, Wayne MA, Woolard RH, Opie LH, Rackley CE, Apstein CS, Udelson JE. Out-of-hospital administration of intravenous glucose-insulin-potassium in patients with suspected acute coronary syndromes: the IMMEDIATE randomized controlled trial. JAMA. 2012 May 9;307(18):1925-33. doi: 10.1001/jama.2012.426. Epub 2012 Mar 27.
PMID: 22452807RESULTSelker HP, Udelson JE, Massaro JM, Ruthazer R, D'Agostino RB, Griffith JL, Sheehan PR, Desvigne-Nickens P, Rosenberg Y, Tian X, Vickery EM, Atkins JM, Aufderheide TP, Sayah AJ, Pirrallo RG, Levy MK, Richards ME, Braude DA, Doyle DD, Frascone RJ, Kosiak DJ, Leaming JM, Van Gelder CM, Walter GP, Wayne MA, Woolard RH, Beshansky JR. One-year outcomes of out-of-hospital administration of intravenous glucose, insulin, and potassium (GIK) in patients with suspected acute coronary syndromes (from the IMMEDIATE [Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care] Trial). Am J Cardiol. 2014 May 15;113(10):1599-605. doi: 10.1016/j.amjcard.2014.02.010. Epub 2014 Mar 1.
PMID: 24792735DERIVEDBeshansky JR, Sheehan PR, Klima KJ, Hadar N, Vickery EM, Selker HP. A community consultation survey to evaluate support for and success of the IMMEDIATE trial. Clin Trials. 2014 Apr;11(2):178-86. doi: 10.1177/1740774514526476.
PMID: 24686107DERIVEDSullivan AL, Beshansky JR, Ruthazer R, Murman DH, Mader TJ, Selker HP. Factors associated with longer time to treatment for patients with suspected acute coronary syndromes: a cohort study. Circ Cardiovasc Qual Outcomes. 2014 Jan;7(1):86-94. doi: 10.1161/CIRCOUTCOMES.113.000396. Epub 2014 Jan 14.
PMID: 24425697DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Co-Principal Investigator
- Organization
- Tufts Medical Center
Study Officials
- STUDY CHAIR
Harry Selker, MD, MSPH
Tufts Medical Center, Trial Coordinating Center
- PRINCIPAL INVESTIGATOR
Ralph D'Agostino, PhD
Tufts Medical Center, Data Coordinating Center
- PRINCIPAL INVESTIGATOR
James Udelson, MD
Tufts Medical Center, LV Core Lab
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2004
First Posted
September 13, 2004
Study Start
November 1, 2006
Primary Completion
August 1, 2011
Study Completion
August 1, 2012
Last Updated
March 2, 2016
Results First Posted
January 30, 2013
Record last verified: 2016-02