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

15. juni 2010 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Forventet)

500

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Control
Patients assigned to the control arm will receive usual care for AMI, according to local practice of each participating centre.
Eksperimentell: 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.
Legemiddel: glulisine insulin, glargine insulin
IV infusion of glulisine, SC injection of glargine
Andre navn:
  • Apidra, Lantus

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Population Health Research Institute

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2008

Primær fullføring (Faktiske)

1. juni 2010

Studiet fullført (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først innsendt

18. mars 2008

Først innsendt som oppfylte QC-kriteriene

18. mars 2008

Først lagt ut (Anslag)

21. mars 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

16. juni 2010

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juni 2010

Sist bekreftet

1. juni 2009

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RECREATE Pilot

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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