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Angina, UnstablePhase 3IMMEDIATENCT00091507

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

A Phase 3 study testing GIK in people with Angina, Unstable and Cardiovascular Diseases, run by Tufts Medical Center at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 30 years and older
What is being tested?
GIK
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
911 participants
Where
13 sitesUnited States
Study dates
Nov 2006to Aug 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 12-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).

Who cannot join

  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Albuquerque Site

    Albuquerque, New Mexico, 87131

  • Anchorage Site

    Anchorage, Alaska, 99501

  • Bellingham Site

    Bellingham, Washington, 98225

  • Brockton Site

    Brockton, Massachusetts, 02301

  • Concord Site

    Concord, Massachusetts, 01742

  • Dallas Site

    Dallas, Texas, 75201

  • El Paso Site

    El Paso, Texas, 79905

  • Hershey Site

    Hershey, Pennsylvania, 17033

  • Macon Site

    Macon, Georgia, 31208

  • Milwaukee Site

    Milwaukee, Wisconsin, 53226

  • New Haven Site

    New Haven, Connecticut, 06511

  • St. Paul Site

    Saint Paul, Minnesota, 55128

  • Sioux Falls Site

    Sioux Falls, South Dakota, 57104

Other trials in United States

About this study

Official title: Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care Trial

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).

Read the detailed description

BACKGROUND:

Basic and clinical research suggests intravenous GIK metabolic myocardial support reduces ischemia-induced arrhythmias, progression from unstable angina pectoris (UAP) to acute myocardial infarction (AMI), myocardial infarction (MI) size, and mortality. Also, for ST elevation MI (STEMI), GIK may prolong time of benefit of coronary reperfusion. These effects should reduce short- and long-term mortality from ACS, including AMI and UAP, and the propensity for heart failure (HF). These benefits are related to the earliness of ACS, when both risk and opportunity to save lives are highest.

DESIGN NARRATIVE:

This is a randomized, placebo-controlled, double-blinded, multicenter clinical trial of IMMEDIATE GIK as early as possible in ACS in the prehospital emergency medical service (EMS) setting. Distinct from prior and ongoing GIK trials, this will test GIK for all ACS rather than only for AMI or STEMI in prehospital EMS. The primary hypothesis is that early GIK will prevent or reduce the size of acute myocardial infarction. Major secondary hypotheses posit GIK will reduce mortality (30 days and 1 year), reduce pre- or in-hospital cardiac arrest and the propensity for heart failure. Other hypotheses address mechanisms of these effects.

Being tested
GIK, Placebo
Keywords
Acute Coronary Syndrome
Medical subject headings
Angina, Unstable, Cardiovascular Diseases, Heart Diseases, Coronary Disease, Myocardial Infarction, Heart Failure, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GIKDrug

    Also called Glucose-Insulin Potassium

    Intravenous solution, 1.5ml/kg/hour, continuous infusion for total of 12 hours.

  • PlaceboDrug

    Also called Dextrose 5%

    Intravenous solution of Dextrose 5 percent at 1.5 ml/kg/hour for a total of 12 hours.

Study groups in NCT00091507
Study groupRoleWhat they receive
1 -- GIKExperimentalGIK = 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.
Receives: Drug: GIK
2 -- PlaceboPlacebo comparatorDextrose 5%, infused at 1.5 ml/kg/hour for total of 12 hours.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 hours

Secondary outcomes (4)

  1. Cardiac Arrest

    Outcome for all participants who had a cardiac arrest from initial contact in the prehospital setting through their subsequent hospitalization.

    Measured: 1 to 18 hours (From prehospital setting through hospitalization.)

  2. Heart Failure or Death

    Outcome for all participants (composite of re-hospitalization for heart failure or death within 30 days)

    Measured: 30 days

  3. Mortality

    Outcome for all participants (mortality at 30 days).

    Measured: 30 days

  4. Cardiac Arrest or Acute Mortality

    Outcome for all participants (composite of cardiac arrest or acute mortality)

    Measured: Prehospital setting through hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2004 (estimated)
  2. Study startNov 2006
  3. Primary completionAug 2011
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
911 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00091507
Sponsor's protocol ID
165
Other IDs
U01HL077826, U01HL077823, U01HL077822, U01HL077821
Acronym
IMMEDIATE
Status last verified
Feb 2016
First submitted
9 Sep 2004
Last updated
2 Mar 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21366431

  • Selker 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.

    PubMed 22424000

  • Ellis 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.

    PubMed 26644202

  • Ellis 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.

    PubMed 25778467

  • Alkofide 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.

    PubMed 26631004

  • Alkofide 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.

    PubMed 26193887

  • Selker 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.

    PubMed 22452807

  • Selker 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.

    PubMed 24792735

  • Beshansky 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.

    PubMed 24686107

  • Sullivan 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.

    PubMed 24425697

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GIK in people with Angina, Unstable and Cardiovascular Diseases, run by Tufts Medical Center at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression of Acute Coronary Syndrome to Myocardial Infarction (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00091507, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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