REsearching Coronary REduction by Appropriately Targeting Euglycemia (RECREATE Pilot Study) (RECREATE Pilot)
15 juni 2010 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
500
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Buenos Aires
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Adrogue,, Buenos Aires, Argentina
- Instituto Médico Adrogué
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Nagpur, Indien, 440012
- Avanti Institute of Cardiology
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Assam
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Dt. Dibrugarh, Assam, Indien, 786002
- Assam Medical College Hospital
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Chattisgarh
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Raipur, Chattisgarh, Indien, 492001
- Lifeworth Super Specialty Hospital
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Haryana
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Rohtak, Haryana, Indien, 124001
- Post Graduate Institute of Medical
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Karnataka
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Bangalore, Karnataka, Indien, 560034
- St. Johns Medical College
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Shimoga, Karnataka, Indien, 577201
- Nanjappa Hospital
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Kerala
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Calicut, Kerala, Indien, 673004
- Baby Memorial Hospital
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Kottayam, Kerala, Indien, 686016
- Caritas Hospital
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Maharashtra
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Mumbai, Maharashtra, Indien, 400012
- KEM Hospital
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Wardha, Maharashtra, Indien, 442102
- MGIMS
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Tamilnadu
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Chennai, Tamilnadu, Indien, 600023
- Railway Hospital
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Ontario
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Hamilton, Ontario, Kanada, L8L 2X2
- Hamilton Health Sciences, General Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: Control
Patients assigned to the control arm will receive usual care for AMI, according to local practice of each participating centre.
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Experimentell: 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.
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IV infusion of glulisine, SC injection of glargine
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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The 24-hour difference in mean glucose between the two study groups.
Tidsram: 24 hours
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24 hours
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first)
Tidsram: 7 days or discharge
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7 days or discharge
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The difference in mean glucose level achieved at 30 days between study groups
Tidsram: 30 days
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30 days
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Nonfatal recurrent myocardial infarction, nonfatal stroke, or cardiovascular death (as a composite and as separate outcomes)
Tidsram: Discharge, 30 days, 90 days, 1 year
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Discharge, 30 days, 90 days, 1 year
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Rehospitalization for congestive heart failure
Tidsram: Discharge, 30 days, 90 days, 1 year
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Discharge, 30 days, 90 days, 1 year
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All cause mortality
Tidsram: Discharge, 30 days, 90 days, 1 year
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Discharge, 30 days, 90 days, 1 year
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Resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes)
Tidsram: Discharge, 30 days, 90 days, 1 year
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Discharge, 30 days, 90 days, 1 year
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Cardiogenic shock
Tidsram: Discharge, 30 days, 90 days, 1 year
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Discharge, 30 days, 90 days, 1 year
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Cardiac procedures
Tidsram: Discharge, 30 days, 90 days, 1 year
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Discharge, 30 days, 90 days, 1 year
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Rehospitalization for any cause
Tidsram: Discharge, 30 days, 90 days, 1 year
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Discharge, 30 days, 90 days, 1 year
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Symptomatic and severe hypoglycemic episodes
Tidsram: Discharge, 30 days, 90 days, 1 year
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Discharge, 30 days, 90 days, 1 year
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Hypokalemic episodes
Tidsram: Discharge
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Discharge
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Hertzel Gerstein, MD, MSc, FRCPC, McMaster University
- Huvudutredare: Salim Yusuf, DPhil, FRCPC, FRSC, McMaster University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2008
Primärt slutförande (Faktisk)
1 juni 2010
Avslutad studie (Faktisk)
1 juni 2010
Studieregistreringsdatum
Först inskickad
18 mars 2008
Först inskickad som uppfyllde QC-kriterierna
18 mars 2008
Första postat (Uppskatta)
21 mars 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 juni 2010
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 juni 2010
Senast verifierad
1 juni 2009
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RECREATE Pilot
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
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