ID

35558

Beschreibung

Eliminate Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02245087

Link

https://clinicaltrials.gov/show/NCT02245087

Stichworte

Versionen (1)
  1. 08.03.19 08.03.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. März 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02245087

Englisch

Eligibility Coronary Artery Disease NCT02245087

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
men 35-50 years of age
Beschreibung

Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
women 45 - 59 years of age (must be sterile or >2 years postmenopausal)
Beschreibung

Gender | Age | Female Sterilization | Postmenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0232970
ldl cholesterol greater than 1.8 mmol/l (70 mg/dl) based on testing performed within 1 year
Beschreibung

Serum LDL cholesterol measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0428474
one risk factor for coronary heart disease other than lipid abnormality:
Beschreibung

Risk factor Quantity Coronary heart disease | Exception Lipid abnormality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0010068
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0549634
hypertension [bp >140 mmhg systolic]
Beschreibung

Hypertensive disease | Systolic Pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0871470
family history of premature myocardial infarction [<60 years]
Beschreibung

Family history Myocardial Infarction Early

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0027051
UMLS CUI [1,3]
C1279919
south asian ethnic history
Beschreibung

South Asian

Datentyp

boolean

Alias
UMLS CUI [1]
C1519427
currently smoking
Beschreibung

Tobacco use

Datentyp

boolean

Alias
UMLS CUI [1]
C0543414
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently taking cholesterol lowering medication
Beschreibung

Anticholesteremic Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0003277
qualify for cholesterol lowering medication based on current guidelines
Beschreibung

Qualification Anticholesteremic Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1709790
UMLS CUI [1,2]
C0003277
significant renal dysfunction (creatinine clearance <30 ml/min)
Beschreibung

Renal dysfunction | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0373595
significant hepatic dysfunction (ast/alt >2.0 times upper limit of normal)
Beschreibung

Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
active malignancy
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
diabetes
Beschreibung

Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
progressive or terminal illness, or other condition in which subject is unlikely to survive the study period
Beschreibung

Progressive Disease | Terminal illness | Condition Survival aspects Completion of clinical trial Unlikely

Datentyp

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2]
C0679247
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0220921
UMLS CUI [3,3]
C2732579
UMLS CUI [3,4]
C0750558
known allergy, hypersensitivity (anaphylaxis) ar adverse reaction to any statin
Beschreibung

Statin allergy | Anaphylaxis Statins | Adverse reactions Statins

Datentyp

boolean

Alias
UMLS CUI [1]
C0571873
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0360714
UMLS CUI [3,1]
C0559546
UMLS CUI [3,2]
C0360714
participation in a clinical trial (except observational studies) within previous 30 days
Beschreibung

Study Subject Participation Status | Exception Observational Study

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1518527
received any investigation product within 30 days prior to participation in this clinical trial
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
previously enrolled in this clinical trial
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT02245087

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
men 35-50 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender | Age | Female Sterilization | Postmenopausal state
Item
women 45 - 59 years of age (must be sterile or >2 years postmenopausal)
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
Serum LDL cholesterol measurement
Item
ldl cholesterol greater than 1.8 mmol/l (70 mg/dl) based on testing performed within 1 year
boolean
C0428474 (UMLS CUI [1])
Risk factor Quantity Coronary heart disease | Exception Lipid abnormality
Item
one risk factor for coronary heart disease other than lipid abnormality:
boolean
C0035648 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0010068 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0549634 (UMLS CUI [2,2])
Hypertensive disease | Systolic Pressure
Item
hypertension [bp >140 mmhg systolic]
boolean
C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Family history Myocardial Infarction Early
Item
family history of premature myocardial infarction [<60 years]
boolean
C0241889 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,3])
South Asian
Item
south asian ethnic history
boolean
C1519427 (UMLS CUI [1])
Tobacco use
Item
currently smoking
boolean
C0543414 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Anticholesteremic Agents
Item
currently taking cholesterol lowering medication
boolean
C0003277 (UMLS CUI [1])
Qualification Anticholesteremic Agents
Item
qualify for cholesterol lowering medication based on current guidelines
boolean
C1709790 (UMLS CUI [1,1])
C0003277 (UMLS CUI [1,2])
Renal dysfunction | Creatinine clearance measurement
Item
significant renal dysfunction (creatinine clearance <30 ml/min)
boolean
C3279454 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
significant hepatic dysfunction (ast/alt >2.0 times upper limit of normal)
boolean
C0086565 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Malignant Neoplasms
Item
active malignancy
boolean
C0006826 (UMLS CUI [1])
Diabetes Mellitus
Item
diabetes
boolean
C0011849 (UMLS CUI [1])
Progressive Disease | Terminal illness | Condition Survival aspects Completion of clinical trial Unlikely
Item
progressive or terminal illness, or other condition in which subject is unlikely to survive the study period
boolean
C1335499 (UMLS CUI [1])
C0679247 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C0220921 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C0750558 (UMLS CUI [3,4])
Statin allergy | Anaphylaxis Statins | Adverse reactions Statins
Item
known allergy, hypersensitivity (anaphylaxis) ar adverse reaction to any statin
boolean
C0571873 (UMLS CUI [1])
C0002792 (UMLS CUI [2,1])
C0360714 (UMLS CUI [2,2])
C0559546 (UMLS CUI [3,1])
C0360714 (UMLS CUI [3,2])
Study Subject Participation Status | Exception Observational Study
Item
participation in a clinical trial (except observational studies) within previous 30 days
boolean
C2348568 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1518527 (UMLS CUI [2,2])
Investigational New Drugs
Item
received any investigation product within 30 days prior to participation in this clinical trial
boolean
C0013230 (UMLS CUI [1])
Study Subject Participation Status
Item
previously enrolled in this clinical trial
boolean
C2348568 (UMLS CUI [1])
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