ID

29864

Description

REsearching Coronary REduction by Appropriately Targeting Euglycemia (RECREATE Pilot Study); ODM derived from: https://clinicaltrials.gov/show/NCT00640991

Lien

https://clinicaltrials.gov/show/NCT00640991

Mots-clés

Versions (1)
  1. 24/04/2018 24/04/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

24 avril 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Hyperglycemia NCT00640991

Anglais

Eligibility Hyperglycemia NCT00640991

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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:
Description

Diabetes Mellitus Absent | Diabetes Mellitus, Non-Insulin-Dependent | Acute myocardial infarction Suspected

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C0155626
UMLS CUI [3,2]
C0750491
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
Description

Sign or Symptom Acute myocardial infarction | Electrocardiographic changes | ST segment elevated persistent Lead measurement Quantity | Left Bundle-Branch Block New

Type de données

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0155626
UMLS CUI [2]
C0855329
UMLS CUI [3,1]
C2216134
UMLS CUI [3,2]
C0524167
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0023211
UMLS CUI [4,2]
C0205314
onset of symptoms within 24 hours before hospital presentation
Description

Onset of Symptoms Before Hospital visit

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332162
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0545092
capillary blood glucose level on presentation > or = 8.0 mmol/l (144 mg/dl)
Description

Capillary blood glucose measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0457578
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient with conditions that require the administration of insulin, including:
Description

Patient need for Insulin

Type de données

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0021641
type 1 diabetes mellitus, defined by a documented history of diabetes mellitus before the age of 30
Description

Diabetes Mellitus, Insulin-Dependent

Type de données

boolean

Alias
UMLS CUI [1]
C0011854
type 2 diabetes mellitus that was treated with insulin prior to ami presentation
Description

Insulin regime Non-Insulin-Dependent Diabetes Mellitus

Type de données

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0011860
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)
Description

Non-Insulin-Dependent Diabetes Mellitus Poorly controlled Very | Capillary blood glucose measurement | Blood glucose increased

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C3853134
UMLS CUI [1,3]
C0442824
UMLS CUI [2]
C0457578
UMLS CUI [3]
C0595877
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
Description

Hypoglycaemic episodes Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C0205082
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)
Description

End Stage Liver Disease | End Stage Liver Disease Suspected | Risk Hypoglycemia | Liver Dysfunction | Regulation Impaired Glucose homeostasis

Type de données

boolean

Alias
UMLS CUI [1]
C0745744
UMLS CUI [2,1]
C0745744
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C0035647
UMLS CUI [3,2]
C0020615
UMLS CUI [4]
C0086565
UMLS CUI [5,1]
C1327622
UMLS CUI [5,2]
C0221099
UMLS CUI [5,3]
C1326961
cardiogenic shock on admission (due to the inaccuracy of glucose meter readings)
Description

Shock, Cardiogenic

Type de données

boolean

Alias
UMLS CUI [1]
C0036980
documented pregnancy
Description

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
any concomitant disease (e.g. cancer) that might limit life expectancy to less than 90 days
Description

Comorbidity Limiting Life Expectancy | Malignant Neoplasms

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0023671
UMLS CUI [2]
C0006826
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.)
Description

Protocol Compliance Poor | Factor compromises Follow-up | Address Lacking | Residence Remote

Type de données

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0542537
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C3274571
UMLS CUI [3,1]
C1442065
UMLS CUI [3,2]
C0332268
UMLS CUI [4,1]
C0237096
UMLS CUI [4,2]
C0205157
prior enrollment in this trial or current enrollment in another trial of st-segment elevation myocardial infarction
Description

Study Subject Participation Status | ST segment elevation myocardial infarction

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1536220
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Similar models

Eligibility Hyperglycemia NCT00640991

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus Absent | Diabetes Mellitus, Non-Insulin-Dependent | Acute myocardial infarction Suspected
Item
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:
boolean
C0011849 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2])
C0155626 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
Sign or Symptom Acute myocardial infarction | Electrocardiographic changes | ST segment elevated persistent Lead measurement Quantity | Left Bundle-Branch Block New
Item
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
boolean
C3540840 (UMLS CUI [1,1])
C0155626 (UMLS CUI [1,2])
C0855329 (UMLS CUI [2])
C2216134 (UMLS CUI [3,1])
C0524167 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0023211 (UMLS CUI [4,1])
C0205314 (UMLS CUI [4,2])
Onset of Symptoms Before Hospital visit
Item
onset of symptoms within 24 hours before hospital presentation
boolean
C0332162 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0545092 (UMLS CUI [1,4])
Capillary blood glucose measurement
Item
capillary blood glucose level on presentation > or = 8.0 mmol/l (144 mg/dl)
boolean
C0457578 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patient need for Insulin
Item
patient with conditions that require the administration of insulin, including:
boolean
C0686904 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus, defined by a documented history of diabetes mellitus before the age of 30
boolean
C0011854 (UMLS CUI [1])
Insulin regime Non-Insulin-Dependent Diabetes Mellitus
Item
type 2 diabetes mellitus that was treated with insulin prior to ami presentation
boolean
C0557978 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
Non-Insulin-Dependent Diabetes Mellitus Poorly controlled Very | Capillary blood glucose measurement | Blood glucose increased
Item
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)
boolean
C0011860 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0442824 (UMLS CUI [1,3])
C0457578 (UMLS CUI [2])
C0595877 (UMLS CUI [3])
Hypoglycaemic episodes Severe
Item
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
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
End Stage Liver Disease | End Stage Liver Disease Suspected | Risk Hypoglycemia | Liver Dysfunction | Regulation Impaired Glucose homeostasis
Item
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)
boolean
C0745744 (UMLS CUI [1])
C0745744 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0035647 (UMLS CUI [3,1])
C0020615 (UMLS CUI [3,2])
C0086565 (UMLS CUI [4])
C1327622 (UMLS CUI [5,1])
C0221099 (UMLS CUI [5,2])
C1326961 (UMLS CUI [5,3])
Shock, Cardiogenic
Item
cardiogenic shock on admission (due to the inaccuracy of glucose meter readings)
boolean
C0036980 (UMLS CUI [1])
Pregnancy
Item
documented pregnancy
boolean
C0032961 (UMLS CUI [1])
Comorbidity Limiting Life Expectancy | Malignant Neoplasms
Item
any concomitant disease (e.g. cancer) that might limit life expectancy to less than 90 days
boolean
C0009488 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2])
Protocol Compliance Poor | Factor compromises Follow-up | Address Lacking | Residence Remote
Item
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.)
boolean
C0525058 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C1521761 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
C1442065 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C0237096 (UMLS CUI [4,1])
C0205157 (UMLS CUI [4,2])
Study Subject Participation Status | ST segment elevation myocardial infarction
Item
prior enrollment in this trial or current enrollment in another trial of st-segment elevation myocardial infarction
boolean
C2348568 (UMLS CUI [1])
C1536220 (UMLS CUI [2])
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