ID

40824

Description

Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and Cardiovascular Event Assessments; ODM derived from: https://clinicaltrials.gov/show/NCT01173939

Link

https://clinicaltrials.gov/show/NCT01173939

Keywords

Versions (1)
  1. 5/19/20 5/19/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 19, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypercholesterolemia NCT01173939

English

Eligibility Hypercholesterolemia NCT01173939

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients meeting the following inclusion criteria will be included in the study:
Description

Inclusion criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
1. patients giving voluntary written consent to participate in the study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. male or female patients 50 years of age or older (at informed consent)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. hypercholesterolemia patients (untreated patients: ldl-c level ≥140 mg/dl; treated patients: ldl-c level ≥120 mg/dl)
Description

Hypercholesterolemia | Serum LDL cholesterol measurement | Patients Untreated | Patients Treated

Data type

boolean

Alias
UMLS CUI [1]
C0020443
UMLS CUI [2]
C0428474
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0332155
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C1522326
4. type 2 diabetes patients (hba1c level ≥6.1% (jds criteria), with or without history of drug therapy)
Description

Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Pharmacotherapy | Pharmacotherapy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0474680
UMLS CUI [3]
C0013216
UMLS CUI [4,1]
C0013216
UMLS CUI [4,2]
C0332197
5. hypertension patients (sbp ≥130 mmhg or dbp ≥80 mmhg, with or without history of drug therapy)
Description

Hypertensive disease | Systolic Pressure | Diastolic blood pressure | Pharmacotherapy | Pharmacotherapy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4]
C0013216
UMLS CUI [5,1]
C0013216
UMLS CUI [5,2]
C0332197
6. patients with two or more of the following risk factors
Description

Risk factors Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1265611
male
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
65 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
smoker
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
l/h ratio: ≥3.0 •hba1c level: ≥8.0%
Description

Serum LDL/HDL ratio measurement | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278197
UMLS CUI [2]
C0474680
left ventricular hypertrophy
Description

Left Ventricular Hypertrophy

Data type

boolean

Alias
UMLS CUI [1]
C0149721
first- or second-degree family history of mace
Description

Adverse events Major Cardiac | Family history First degree | Family history Second degree

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0018787
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C0444502
UMLS CUI [3,1]
C0241889
UMLS CUI [3,2]
C0443298
microalbuminuria (quantitative testing: ≥30 mg/dl), proteinuria (qualitative testing: + or higher) or egfr (<60 ml/min/1.73 m2)
Description

Microalbuminuria measurement | Proteinuria | Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C0740086
UMLS CUI [2]
C0033687
UMLS CUI [3]
C3811844
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients meeting the following criteria will be excluded from the study:
Description

Exclusion Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1550543
1. patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent
Description

rosuvastatin | pitavastatin | atorvastatin

Data type

boolean

Alias
UMLS CUI [1]
C0965129
UMLS CUI [2]
C1101838
UMLS CUI [3]
C0286651
2. patients judged to have familial hypercholesterolemia
Description

Hypercholesterolemia, Familial

Data type

boolean

Alias
UMLS CUI [1]
C0020445
3. patients with a serum triglyceride level of ≥400 mg/dl
Description

Serum Triglyceride Measurement

Data type

boolean

Alias
UMLS CUI [1]
C0542495
4. patients with a history of myocardial infarction
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
5. patients with a history of coronary revascularization (pci or cabg)
Description

Coronary revascularisation | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0877341
UMLS CUI [2]
C1532338
UMLS CUI [3]
C0010055
6. patients with a history of treatment of unstable angina
Description

Therapy Unstable Angina

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0002965
7. patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction)
Description

Cerebrovascular accident | Lacunar Infarction Asymptomatic Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2,1]
C0333559
UMLS CUI [2,2]
C0231221
UMLS CUI [2,3]
C0332196
8. heart failure patients
Description

Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018801
9. patients with a history of hypersensitivity to statins
Description

Statin allergy

Data type

boolean

Alias
UMLS CUI [1]
C0571873
10. patients with a history of drug-induced myopathy
Description

Drug-induced myopathy

Data type

boolean

Alias
UMLS CUI [1]
C0410220
11. patients with poorly controlled arrhythmia
Description

Cardiac Arrhythmia Poorly controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C3853134
12. patients with severe liver or kidney disease
Description

Liver disease Severe | Kidney Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
13. patients with serious concurrent disease, such as malignancy, or patients with severely limited lifespan
Description

Comorbidity Serious | Malignant Neoplasm | Lifespan Limited Severely

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0006826
UMLS CUI [3,1]
C0870809
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0205082
14. patients who are or may be pregnant
Description

Pregnancy | Possible pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
15. patients judged by the investigators to be ineligible for participation in the study for any other reason
Description

Study Subject Participation Status Ineligible

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714
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Similar models

Eligibility Hypercholesterolemia NCT01173939

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Fulfill
Item
patients meeting the following inclusion criteria will be included in the study:
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Informed Consent
Item
1. patients giving voluntary written consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. male or female patients 50 years of age or older (at informed consent)
boolean
C0001779 (UMLS CUI [1])
Hypercholesterolemia | Serum LDL cholesterol measurement | Patients Untreated | Patients Treated
Item
3. hypercholesterolemia patients (untreated patients: ldl-c level ≥140 mg/dl; treated patients: ldl-c level ≥120 mg/dl)
boolean
C0020443 (UMLS CUI [1])
C0428474 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
C0030705 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Pharmacotherapy | Pharmacotherapy Absent
Item
4. type 2 diabetes patients (hba1c level ≥6.1% (jds criteria), with or without history of drug therapy)
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0013216 (UMLS CUI [3])
C0013216 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Hypertensive disease | Systolic Pressure | Diastolic blood pressure | Pharmacotherapy | Pharmacotherapy Absent
Item
5. hypertension patients (sbp ≥130 mmhg or dbp ≥80 mmhg, with or without history of drug therapy)
boolean
C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0013216 (UMLS CUI [4])
C0013216 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Risk factors Quantity
Item
6. patients with two or more of the following risk factors
boolean
C0035648 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Gender
Item
male
boolean
C0079399 (UMLS CUI [1])
Age
Item
65 years of age or older
boolean
C0001779 (UMLS CUI [1])
Tobacco use
Item
smoker
boolean
C0543414 (UMLS CUI [1])
Serum LDL/HDL ratio measurement | Hemoglobin A1c measurement
Item
l/h ratio: ≥3.0 •hba1c level: ≥8.0%
boolean
C1278197 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Left Ventricular Hypertrophy
Item
left ventricular hypertrophy
boolean
C0149721 (UMLS CUI [1])
Adverse events Major Cardiac | Family history First degree | Family history Second degree
Item
first- or second-degree family history of mace
boolean
C0877248 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0018787 (UMLS CUI [1,3])
C0241889 (UMLS CUI [2,1])
C0444502 (UMLS CUI [2,2])
C0241889 (UMLS CUI [3,1])
C0443298 (UMLS CUI [3,2])
Microalbuminuria measurement | Proteinuria | Estimated Glomerular Filtration Rate
Item
microalbuminuria (quantitative testing: ≥30 mg/dl), proteinuria (qualitative testing: + or higher) or egfr (<60 ml/min/1.73 m2)
boolean
C0740086 (UMLS CUI [1])
C0033687 (UMLS CUI [2])
C3811844 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Fulfill
Item
patients meeting the following criteria will be excluded from the study:
boolean
C0680251 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
rosuvastatin | pitavastatin | atorvastatin
Item
1. patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent
boolean
C0965129 (UMLS CUI [1])
C1101838 (UMLS CUI [2])
C0286651 (UMLS CUI [3])
Hypercholesterolemia, Familial
Item
2. patients judged to have familial hypercholesterolemia
boolean
C0020445 (UMLS CUI [1])
Serum Triglyceride Measurement
Item
3. patients with a serum triglyceride level of ≥400 mg/dl
boolean
C0542495 (UMLS CUI [1])
Myocardial Infarction
Item
4. patients with a history of myocardial infarction
boolean
C0027051 (UMLS CUI [1])
Coronary revascularisation | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
Item
5. patients with a history of coronary revascularization (pci or cabg)
boolean
C0877341 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
Therapy Unstable Angina
Item
6. patients with a history of treatment of unstable angina
boolean
C0087111 (UMLS CUI [1,1])
C0002965 (UMLS CUI [1,2])
Cerebrovascular accident | Lacunar Infarction Asymptomatic Excluded
Item
7. patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction)
boolean
C0038454 (UMLS CUI [1])
C0333559 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Heart failure
Item
8. heart failure patients
boolean
C0018801 (UMLS CUI [1])
Statin allergy
Item
9. patients with a history of hypersensitivity to statins
boolean
C0571873 (UMLS CUI [1])
Drug-induced myopathy
Item
10. patients with a history of drug-induced myopathy
boolean
C0410220 (UMLS CUI [1])
Cardiac Arrhythmia Poorly controlled
Item
11. patients with poorly controlled arrhythmia
boolean
C0003811 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
Liver disease Severe | Kidney Disease Severe
Item
12. patients with severe liver or kidney disease
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Comorbidity Serious | Malignant Neoplasm | Lifespan Limited Severely
Item
13. patients with serious concurrent disease, such as malignancy, or patients with severely limited lifespan
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
C0870809 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
Pregnancy | Possible pregnancy
Item
14. patients who are or may be pregnant
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
Study Subject Participation Status Ineligible
Item
15. patients judged by the investigators to be ineligible for participation in the study for any other reason
boolean
C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
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