- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00640991
REsearching Coronary REduction by Appropriately Targeting Euglycemia (RECREATE Pilot Study) (RECREATE Pilot)
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
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
Tilmelding (Forventet)
Fase
- Fase 3
Kontakter og lokationer
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
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
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:
|
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
Efterforskere
- Ledende efterforsker: Hertzel Gerstein, MD, MSc, FRCPC, McMaster University
- Ledende efterforsker: Salim Yusuf, DPhil, FRCPC, FRSC, McMaster University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RECREATE Pilot
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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
-
SanofiAfsluttetDiabetes mellitus, type 1Frankrig
-
SanofiAfsluttetDiabetes mellitus, type 2Forenede Stater
-
SanofiAfsluttetDiabetes mellitus, type 1Bahrain, Kuwait, Qatar, Forenede Arabiske Emirater
-
SanofiAfsluttetInsulin glulisin hos voksne patienter med type 2-diabetes, der får insulin glargin som basal insulinDiabetes mellitus, type 2Forenede Stater
-
SanofiAfsluttet
-
SanofiAfsluttet
-
HaEmek Medical Center, IsraelAfsluttetDiabetes mellitus type 2
-
Emory UniversitySanofiAfsluttetDiabetisk ketoacidoseForenede Stater
-
Guillermo Umpierrez, MDMedical University of South Carolina; Sanofi; Texas A&M UniversityAfsluttetHyperglykæmi | Type 2 diabetesForenede Stater
-
Novo Nordisk A/SAfsluttetDiabetes mellitus, type 2 | DiabetesTyskland