ID

29277

Beskrivning

Dyslipidemia in Cardiovascular Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01029522

Länk

https://clinicaltrials.gov/show/NCT01029522

Nyckelord

Versioner (1)
  1. 2018-03-15 2018-03-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 mars 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Dyslipidemia NCT01029522

Engelsk

Eligibility Dyslipidemia NCT01029522

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. dyslipidemic patients with high-risk cardiovascular disease meeting more than 1 requirement below (ldl-c ≥ 100mg/dl) 1) coronary artery disease
Beskrivning

Dyslipidemia | High risk of Cardiovascular Disease | Serum LDL cholesterol measurement | Coronary Artery Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0242339
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0007222
UMLS CUI [3]
C0428474
UMLS CUI [4]
C1956346
diagnosed with atheroma in coronary ct or angiography, or spect positive or treadmill test positive 2) diabetes mellitus 3) intervened with stent in coronary artery disease more than 1 year before 4) diagnosed with atheroma in carotid artery 5) peripheral artery disease
Beskrivning

Atheroma CT Coronary | Atheroma Coronary angiography | SPECT Positive | Treadmill Test Positive | Diabetes Mellitus | Placement of stent Previous Coronary Artery Disease | Carotid Atherosclerosis | Peripheral Arterial Diseases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0264956
UMLS CUI [1,2]
C0040405
UMLS CUI [1,3]
C1522318
UMLS CUI [2,1]
C0264956
UMLS CUI [2,2]
C0085532
UMLS CUI [3,1]
C0040399
UMLS CUI [3,2]
C1514241
UMLS CUI [4,1]
C0087110
UMLS CUI [4,2]
C1514241
UMLS CUI [5]
C0011849
UMLS CUI [6,1]
C0522776
UMLS CUI [6,2]
C0205156
UMLS CUI [6,3]
C1956346
UMLS CUI [7]
C0577631
UMLS CUI [8]
C1704436
2. aged 20~85 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. volunteers consented with participating clinical trial and submitted consent paper
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. experimental examination at screening 1) active liver disease or more than 2 x uln of ast/alt 2) creatine kinase > 2 x uln 3) creatinine > 2.5mg/dl 4) triglycerides > 500mg/dl
Beskrivning

Liver disease | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated creatine kinase | Creatinine measurement, serum | Triglycerides measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151576
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0202236
2. intervened with stent in coronary artery disease less than 1 year before
Beskrivning

Placement of stent Coronary Artery Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0522776
UMLS CUI [1,2]
C1956346
3. hyper-sensitive or resistant to other hmg-coa reductase inhibitors, or experienced serious adverse events
Beskrivning

HMG COA reductase inhibitor allergy | Statins Resistant | Serious Adverse Event

Datatyp

boolean

Alias
UMLS CUI [1]
C0571873
UMLS CUI [2,1]
C0360714
UMLS CUI [2,2]
C0332325
UMLS CUI [3]
C1519255
4. patients taking dyslipidemic treatments within 4 weeks (hmg-coa reductase inhibitors, fibrates, nicotinic acids or bile acid resins, etc.)
Beskrivning

Therapeutic procedure Dyslipidemia | Statins | Fibrates | Nicotinic Acids | Bile-acid Binding Resin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0242339
UMLS CUI [2]
C0360714
UMLS CUI [3]
C1449704
UMLS CUI [4]
C0028049
UMLS CUI [5]
C2266924
5. as uncontrolled dm patients, hba1c≥11% or fasting plasma glucose ≥200mg/dl
Beskrivning

Diabetic - poor control | Glucohemoglobin measurement | Plasma fasting glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C0202054
UMLS CUI [3]
C0583513
6. dbp > 100mmhg, sbp > 160mmhg
Beskrivning

Diastolic blood pressure | Systolic Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0428883
UMLS CUI [2]
C0871470
7. diagnosed with myopathy
Beskrivning

Myopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0026848
8. appear to be a risk of myopathy below
Beskrivning

At risk Myopathy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C0026848
renal impairment or prior renal dysfunction
Beskrivning

Renal Insufficiency | Renal dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C3279454
hypothyroidism
Beskrivning

Hypothyroidism

Datatyp

boolean

Alias
UMLS CUI [1]
C0020676
genetic defects or family history of myopathy
Beskrivning

Defect Genetic Myopathy | Family history Myopathy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457869
UMLS CUI [1,2]
C0314603
UMLS CUI [1,3]
C0026848
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C0026848
experienced prior muscle toxicity with taking statins or fibrates
Beskrivning

Muscle Toxicity | Statins | Fibrates

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026845
UMLS CUI [1,2]
C0600688
UMLS CUI [2]
C0360714
UMLS CUI [3]
C1449704
prior liver disease or higher intakes of alcohol
Beskrivning

Liver disease | Alcohol consumption High

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0205250
aged over 70, and a risk of myopathy
Beskrivning

Age | At risk Myopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0026848
9. women pregnant or breast-feeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
10. women capable of pregnancy without using contraceptives
Beskrivning

Childbearing Potential Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
11. contra-indicated medically or mentally, or forbidden legally
Beskrivning

Medical contraindication | Contraindication mental | illegal

Datatyp

boolean

Alias
UMLS CUI [1]
C1301624
UMLS CUI [2,1]
C0522473
UMLS CUI [2,2]
C0229992
UMLS CUI [3]
C3242151
12. enrolled to other clinical trial within 4 weeks
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
13. impossible to participate clinical trial according to investigator's decision
Beskrivning

Study Subject Participation Status Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0332196
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Similar models

Eligibility Dyslipidemia NCT01029522

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Dyslipidemia | High risk of Cardiovascular Disease | Serum LDL cholesterol measurement | Coronary Artery Disease
Item
1. dyslipidemic patients with high-risk cardiovascular disease meeting more than 1 requirement below (ldl-c ≥ 100mg/dl) 1) coronary artery disease
boolean
C0242339 (UMLS CUI [1])
C0332167 (UMLS CUI [2,1])
C0007222 (UMLS CUI [2,2])
C0428474 (UMLS CUI [3])
C1956346 (UMLS CUI [4])
Atheroma CT Coronary | Atheroma Coronary angiography | SPECT Positive | Treadmill Test Positive | Diabetes Mellitus | Placement of stent Previous Coronary Artery Disease | Carotid Atherosclerosis | Peripheral Arterial Diseases
Item
diagnosed with atheroma in coronary ct or angiography, or spect positive or treadmill test positive 2) diabetes mellitus 3) intervened with stent in coronary artery disease more than 1 year before 4) diagnosed with atheroma in carotid artery 5) peripheral artery disease
boolean
C0264956 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C1522318 (UMLS CUI [1,3])
C0264956 (UMLS CUI [2,1])
C0085532 (UMLS CUI [2,2])
C0040399 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0087110 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0011849 (UMLS CUI [5])
C0522776 (UMLS CUI [6,1])
C0205156 (UMLS CUI [6,2])
C1956346 (UMLS CUI [6,3])
C0577631 (UMLS CUI [7])
C1704436 (UMLS CUI [8])
Age
Item
2. aged 20~85 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
3. volunteers consented with participating clinical trial and submitted consent paper
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver disease | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated creatine kinase | Creatinine measurement, serum | Triglycerides measurement
Item
1. experimental examination at screening 1) active liver disease or more than 2 x uln of ast/alt 2) creatine kinase > 2 x uln 3) creatinine > 2.5mg/dl 4) triglycerides > 500mg/dl
boolean
C0023895 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151576 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0202236 (UMLS CUI [6])
Placement of stent Coronary Artery Disease
Item
2. intervened with stent in coronary artery disease less than 1 year before
boolean
C0522776 (UMLS CUI [1,1])
C1956346 (UMLS CUI [1,2])
HMG COA reductase inhibitor allergy | Statins Resistant | Serious Adverse Event
Item
3. hyper-sensitive or resistant to other hmg-coa reductase inhibitors, or experienced serious adverse events
boolean
C0571873 (UMLS CUI [1])
C0360714 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
C1519255 (UMLS CUI [3])
Therapeutic procedure Dyslipidemia | Statins | Fibrates | Nicotinic Acids | Bile-acid Binding Resin
Item
4. patients taking dyslipidemic treatments within 4 weeks (hmg-coa reductase inhibitors, fibrates, nicotinic acids or bile acid resins, etc.)
boolean
C0087111 (UMLS CUI [1,1])
C0242339 (UMLS CUI [1,2])
C0360714 (UMLS CUI [2])
C1449704 (UMLS CUI [3])
C0028049 (UMLS CUI [4])
C2266924 (UMLS CUI [5])
Diabetic - poor control | Glucohemoglobin measurement | Plasma fasting glucose measurement
Item
5. as uncontrolled dm patients, hba1c≥11% or fasting plasma glucose ≥200mg/dl
boolean
C0421258 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
C0583513 (UMLS CUI [3])
Diastolic blood pressure | Systolic Pressure
Item
6. dbp > 100mmhg, sbp > 160mmhg
boolean
C0428883 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Myopathy
Item
7. diagnosed with myopathy
boolean
C0026848 (UMLS CUI [1])
At risk Myopathy
Item
8. appear to be a risk of myopathy below
boolean
C1444641 (UMLS CUI [1,1])
C0026848 (UMLS CUI [1,2])
Renal Insufficiency | Renal dysfunction
Item
renal impairment or prior renal dysfunction
boolean
C1565489 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
Hypothyroidism
Item
hypothyroidism
boolean
C0020676 (UMLS CUI [1])
Defect Genetic Myopathy | Family history Myopathy
Item
genetic defects or family history of myopathy
boolean
C1457869 (UMLS CUI [1,1])
C0314603 (UMLS CUI [1,2])
C0026848 (UMLS CUI [1,3])
C0241889 (UMLS CUI [2,1])
C0026848 (UMLS CUI [2,2])
Muscle Toxicity | Statins | Fibrates
Item
experienced prior muscle toxicity with taking statins or fibrates
boolean
C0026845 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C0360714 (UMLS CUI [2])
C1449704 (UMLS CUI [3])
Liver disease | Alcohol consumption High
Item
prior liver disease or higher intakes of alcohol
boolean
C0023895 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Age | At risk Myopathy
Item
aged over 70, and a risk of myopathy
boolean
C0001779 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0026848 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
9. women pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent
Item
10. women capable of pregnancy without using contraceptives
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Medical contraindication | Contraindication mental | illegal
Item
11. contra-indicated medically or mentally, or forbidden legally
boolean
C1301624 (UMLS CUI [1])
C0522473 (UMLS CUI [2,1])
C0229992 (UMLS CUI [2,2])
C3242151 (UMLS CUI [3])
Study Subject Participation Status
Item
12. enrolled to other clinical trial within 4 weeks
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status Excluded
Item
13. impossible to participate clinical trial according to investigator's decision
boolean
C2348568 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
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