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REsearching Coronary REduction by Appropriately Targeting Euglycemia (RECREATE Pilot Study) (RECREATE Pilot)

15. juni 2010 opdateret af: Population Health Research Institute

An International Multicentre Randomized Controlled Trial of Intensive Insulin Therapy Targeting Normoglycemia In Acute Myocardial Infarction: the RECREATE (REsearching Coronary REduction by Appropriately Targeting Euglycemia) Pilot Study

Insulin will safely reduce glucose levels in patients with acute ST-elevation myocardial infarction and admission hyperglycemia.

Studieoversigt

Detaljeret beskrivelse

Patients will be randomly assigned to either the control arm and will receive usual AMI care or the experimental arm, which will include routine AMI care as well as intensive therapy intervention.

In addition to the capillary blood glucose measurements obtained to titrate insulin doses in the experimental arm patients, laboratory plasma glucose will be drawn in all patients at randomization, 10, 24, 48, and 72 hours post randomization, 7 days post randomization (or hospital discharge if that occurs first), and 30 days post randomization.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

500

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Buenos Aires
      • Adrogue,, Buenos Aires, Argentina
        • Instituto Médico Adrogué
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences, General Site
      • Nagpur, Indien, 440012
        • Avanti Institute of Cardiology
    • Assam
      • Dt. Dibrugarh, Assam, Indien, 786002
        • Assam Medical College Hospital
    • Chattisgarh
      • Raipur, Chattisgarh, Indien, 492001
        • Lifeworth Super Specialty Hospital
    • Haryana
      • Rohtak, Haryana, Indien, 124001
        • Post Graduate Institute of Medical
    • Karnataka
      • Bangalore, Karnataka, Indien, 560034
        • St. Johns Medical College
      • Shimoga, Karnataka, Indien, 577201
        • Nanjappa Hospital
    • Kerala
      • Calicut, Kerala, Indien, 673004
        • Baby Memorial Hospital
      • Kottayam, Kerala, Indien, 686016
        • Caritas Hospital
    • Maharashtra
      • Mumbai, Maharashtra, Indien, 400012
        • KEM Hospital
      • Wardha, Maharashtra, Indien, 442102
        • MGIMS
    • Tamilnadu
      • Chennai, Tamilnadu, Indien, 600023
        • Railway Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Both nondiabetic patients and patients with non-insulin-requiring type 2 diabetes mellitus admitted with a suspected AMI are eligible if they meet the following criteria:

  • Signs or symptoms of AMI with definite ECG changes, defined as persistent ST-segment elevation (> or = than 1 mm)in two or more contiguous leads, or new left bundle branch block
  • Onset of symptoms within 24 hours before hospital presentation
  • Capillary blood glucose level on presentation > or = 8.0 mmol/L (144 mg/dL)

Exclusion Criteria:

  • Patient with conditions that REQUIRE the administration of insulin, including:

    • Type 1 diabetes mellitus, defined by a documented history of diabetes mellitus before the age of 30
    • Type 2 diabetes mellitus that was treated with insulin prior to AMI presentation
    • Type 2 diabetes mellitus that is known to be very poorly controlled (e.g. admission capillary blood glucose > 16.0 mmol/L (288 mg/dL)or marked elevation in glucose for which the site investigator plans to treat with insulin therapy)
  • A history of severe hypoglycemic episodes (defined as hypoglycemia with symptoms which the patient is unable to reverse without the assistance of another person) within the past two years
  • Known or suspected end-stage liver disease (due to the risk of hypoglycemia in the setting of liver dysfunction and consequent impaired regulation of glucose homeostasis)
  • Cardiogenic shock on admission (due to the inaccuracy of glucose meter readings)
  • Documented pregnancy
  • Any concomitant disease (e.g. cancer) that might limit life expectancy to less than 90 days
  • Anticipated poor adherence with study treatments or an other factor that might jeopardize 90-day follow-up (e.g. no fixed address, long distance to hospital, etc.)
  • Prior enrollment in this trial or current enrollment in another trial of ST-segment elevation myocardial infarction

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
Patients assigned to the control arm will receive usual care for AMI, according to local practice of each participating centre.
Eksperimentel: Intervention
The experimental arm will have an IV infusion of glulisine insulin started directly after randomization for at least 24 hours and for as long as CCU-level care is required, and the insulin infusion will be adjusted to achieve and maintain a target glucose range of 5.0-6.6 mmol/L (90-118 mg/dL). Once transferred to the ward, patients in the experimental arm will switch to glargine insulin and will continue this treatment for the remainder of their hospitalization and after hospital discharge, for a total duration of 30 days post randomization.
IV infusion of glulisine, SC injection of glargine
Andre navne:
  • Apidra, Lantus

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The 24-hour difference in mean glucose between the two study groups.
Tidsramme: 24 hours
24 hours

Sekundære resultatmål

Resultatmål
Tidsramme
The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first)
Tidsramme: 7 days or discharge
7 days or discharge
The difference in mean glucose level achieved at 30 days between study groups
Tidsramme: 30 days
30 days
Nonfatal recurrent myocardial infarction, nonfatal stroke, or cardiovascular death (as a composite and as separate outcomes)
Tidsramme: Discharge, 30 days, 90 days, 1 year
Discharge, 30 days, 90 days, 1 year
Rehospitalization for congestive heart failure
Tidsramme: Discharge, 30 days, 90 days, 1 year
Discharge, 30 days, 90 days, 1 year
All cause mortality
Tidsramme: Discharge, 30 days, 90 days, 1 year
Discharge, 30 days, 90 days, 1 year
Resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes)
Tidsramme: Discharge, 30 days, 90 days, 1 year
Discharge, 30 days, 90 days, 1 year
Cardiogenic shock
Tidsramme: Discharge, 30 days, 90 days, 1 year
Discharge, 30 days, 90 days, 1 year
Cardiac procedures
Tidsramme: Discharge, 30 days, 90 days, 1 year
Discharge, 30 days, 90 days, 1 year
Rehospitalization for any cause
Tidsramme: Discharge, 30 days, 90 days, 1 year
Discharge, 30 days, 90 days, 1 year
Symptomatic and severe hypoglycemic episodes
Tidsramme: Discharge, 30 days, 90 days, 1 year
Discharge, 30 days, 90 days, 1 year
Hypokalemic episodes
Tidsramme: Discharge
Discharge

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Hertzel Gerstein, MD, MSc, FRCPC, McMaster University
  • Ledende efterforsker: Salim Yusuf, DPhil, FRCPC, FRSC, McMaster University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2008

Primær færdiggørelse (Faktiske)

1. juni 2010

Studieafslutning (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først indsendt

18. marts 2008

Først indsendt, der opfyldte QC-kriterier

18. marts 2008

Først opslået (Skøn)

21. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. juni 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2010

Sidst verificeret

1. juni 2009

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med glulisine insulin, glargine insulin

3
Abonner