Eligibility Hypertension NCT01075698

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StudyEvent: Eligibility
1. Eligibility Hypertension NCT01075698

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Criteria

Item Group

Outpatients

Item

1. outpatients

boolean

C0029921 (UMLS CUI [1])

Age

Item

2. age: ≥ 40 to < 80

boolean

C0001779 (UMLS CUI [1])

Hypertensive disease | Systolic Pressure | Diastolic blood pressure

Item

3. hypertension: systolic blood pressure of ≥ 140 mmhg or diastolic blood pressure of ≥

boolean

C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])

Sitting blood pressure | Systolic Pressure | Diastolic blood pressure | Requirement Antihypertensive therapy

Item

90 mmhg in the two latest measurements of casual blood pressure (in the sitting position) regardless of treated or untreated condition, or systolic blood pressure of < 140 mmhg and diastolic blood pressure of < 90 mmhg that require antihypertensive treatment.

boolean

C0580946 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C1514873 (UMLS CUI [4,1])
C0585941 (UMLS CUI [4,2])

Assessment Hypertensive disease | Blood pressure determination | Average Measurement Quantity

Item

assessment of hypertension: blood pressure will be measured at least twice at an interval of 1 to 2 minutes. if the measured values obtained are substantially different, additional measurements will be performed and the average of two stable measurements will be used for assessment.

boolean

C1516048 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
C0005824 (UMLS CUI [2])
C1510992 (UMLS CUI [3,1])
C0242485 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])

Informed Consent

Item

4. patients who have given consent to participate in the present study.

boolean

C0021430 (UMLS CUI [1])

Cardiovascular risk

Item

cardiovascular risks:

boolean

C4324389 (UMLS CUI [1])

Diabetes Mellitus | Diabetes Mellitus, Non-Insulin-Dependent

Item

1. diabetes mellitus; type 2 diabetes mellitus

boolean

C0011849 (UMLS CUI [1])
C0011860 (UMLS CUI [2])

Item

2. kidney; serum creatinine: 1.2 mg/dl - < 2.0 mg/dl for males, 1.0 mg/dl - < 2.0 mg/dl for females proteinuria: qualitative value of ≥ +1 (quantitative value: proteinuria with the value of ≥ 0.3 g/g・cr in casual urine when adjusted with urine creatinine) ckd stage 3 or higher (gfr < 60 ml/min/1.73 m2)

boolean

C0022646 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0033687 (UMLS CUI [4])
C2074731 (UMLS CUI [5])
C0017654 (UMLS CUI [6])

Item

3. heart; previous myocardial infarction noted more than 6 months before obtaining the informed consent diagnosis of angina pectoris diagnosis of heart failure (nyha i or ii class) diagnosis of left ventricular hypertrophy (left ventricular posterior wall of ≥ 12 mm evidenced by echocardiography performed prior to obtaining the informed consent, or sv1+rv5 of ≥ 35 mm noted as ecg finding) diagnosis of transient or persisting atrial fibrillation

boolean

C0018787 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0149721 (UMLS CUI [5])
C0004238 (UMLS CUI [6,1])
C0205374 (UMLS CUI [6,2])
C2585653 (UMLS CUI [7])

Brain | Cerebral Infarction | Cerebral Hemorrhage | Subarachnoid Hemorrhage | Transient Ischemic Attack

Item

4. brain; previous cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient cerebral ischemic attack noted more than 6 months before obtaining the informed consent

boolean

C0006104 (UMLS CUI [1])
C0007785 (UMLS CUI [2])
C2937358 (UMLS CUI [3])
C0038525 (UMLS CUI [4])
C0007787 (UMLS CUI [5])

Peripheral Arterial Diseases | Peripheral artery bypass Lower limb | Angioplasty Lower limb | Ankle brachial pressure index | Intermittent Claudication

Item

5. peripheral arterial diseases; previous lower-limb bypass surgery or angioplasty performed more than 6 months before obtaining the informed consent ankle-brachial pressure index of < 0.9 or intermittent claudication

boolean

C1704436 (UMLS CUI [1])
C3495795 (UMLS CUI [2,1])
C0023216 (UMLS CUI [2,2])
C0162577 (UMLS CUI [3,1])
C0023216 (UMLS CUI [3,2])
C1276055 (UMLS CUI [4])
C0021775 (UMLS CUI [5])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Criteria Any Fulfill

Item

patients who meet any of the following criteria will be excluded from the study.

boolean

C0243161 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])

Diabetes Mellitus, Insulin-Dependent

Item

1. type 1 diabetes mellitus

boolean

C0011854 (UMLS CUI [1])

Kidney Diseases Severe

Item

2. severe renal disorders (serum creatinine of ≥ 2.0 mg/dl)

boolean

C0022658 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])

Item

3. myocardial infarction, percutaneous transluminal angioplasty and bypass surgery of coronary artery/ lower-limb blood vessel, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage and transient cerebral ischemic attack noted within 6 months before initiation of the observation

boolean

C0027051 (UMLS CUI [1])
C2936173 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C4517177 (UMLS CUI [4,1])
C0741847 (UMLS CUI [4,2])
C0007785 (UMLS CUI [5])
C2937358 (UMLS CUI [6])
C0038525 (UMLS CUI [7])
C0007787 (UMLS CUI [8])

Heart failure New York Heart Association Classification

Item

4. diagnosis of heart failure (nyha iii or iv class )

boolean

C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])

Other Coding | Secondary hypertension

Item

5. virulent hypertension and secondary hypertension

boolean

C3846158 (UMLS CUI [1])
C0155616 (UMLS CUI [2])

Pregnancy

Item

6. pregnant women

boolean

C0032961 (UMLS CUI [1])

Drug Allergy

Item

7. clinically relevant allergic symptoms or past history of hypersensitivity to drugs /

boolean

C0013182 (UMLS CUI [1])

Adverse reaction to drug

Item

significant adverse drug reactions

boolean

C0041755 (UMLS CUI [1])

Deficiency of bile secretion | Liver diseases Serious

Item

8. extremely poor bile secretion or serious liver disorders

boolean

C3203690 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])

Malignant Neoplasms Treatment required for

Item

9. treatment-required malignant tumors

boolean

C0006826 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])

Study Subject Participation Status Ineligible

Item

10. patients who are judged by the physician in charge to be ineligible for the study for any other reasons

boolean

C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])

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Eligibility Hypertension NCT01075698