Eligibility Hypercholesterolemia NCT01173939

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StudyEvent: Eligibility
1. Eligibility Hypercholesterolemia NCT01173939

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Inclusion Criteria

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])

Exclusion Criteria

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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Eligibility Hypercholesterolemia NCT01173939