ID

40824

Beschreibung

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

Stichworte

Versionen (1)
  1. 19.05.20 19.05.20 -
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See clinicaltrials.gov

Hochgeladen am

19. Mai 2020

DOI

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Eligibility Hypercholesterolemia NCT01173939

Englisch

Eligibility Hypercholesterolemia NCT01173939

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Inclusion criteria Fulfill

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

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

Age

Datentyp

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)
Beschreibung

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

Datentyp

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)
Beschreibung

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

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Risk factors Quantity

Datentyp

boolean

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

Gender

Datentyp

boolean

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

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
smoker
Beschreibung

Tobacco use

Datentyp

boolean

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

Serum LDL/HDL ratio measurement | Hemoglobin A1c measurement

Datentyp

boolean

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

Left Ventricular Hypertrophy

Datentyp

boolean

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

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

Datentyp

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)
Beschreibung

Microalbuminuria measurement | Proteinuria | Estimated Glomerular Filtration Rate

Datentyp

boolean

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

Exclusion Criteria

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

Exclusion Criteria Fulfill

Datentyp

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
Beschreibung

rosuvastatin | pitavastatin | atorvastatin

Datentyp

boolean

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

Hypercholesterolemia, Familial

Datentyp

boolean

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

Serum Triglyceride Measurement

Datentyp

boolean

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

Myocardial Infarction

Datentyp

boolean

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

Coronary revascularisation | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Datentyp

boolean

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

Therapy Unstable Angina

Datentyp

boolean

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

Cerebrovascular accident | Lacunar Infarction Asymptomatic Excluded

Datentyp

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
Beschreibung

Heart failure

Datentyp

boolean

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

Statin allergy

Datentyp

boolean

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

Drug-induced myopathy

Datentyp

boolean

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

Cardiac Arrhythmia Poorly controlled

Datentyp

boolean

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

Liver disease Severe | Kidney Disease Severe

Datentyp

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
Beschreibung

Comorbidity Serious | Malignant Neoplasm | Lifespan Limited Severely

Datentyp

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
Beschreibung

Pregnancy | Possible pregnancy

Datentyp

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
Beschreibung

Study Subject Participation Status Ineligible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714
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Ähnliche Modelle

Eligibility Hypercholesterolemia NCT01173939

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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