ID

39932

Beskrivning

A Trial of Telmisartan Prevention of Cardiovascular Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01075698

Länk

https://clinicaltrials.gov/show/NCT01075698

Nyckelord

Versioner (2)
  1. 2020-03-04 2020-03-04 -
  2. 2020-03-05 2020-03-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 mars 2020

DOI

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Licens

Creative Commons BY-NC 4.0
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Eligibility Hypertension NCT01075698

Engelsk

Eligibility Hypertension NCT01075698

1 Formulär  
Criteria
Beskrivning

Criteria

1. outpatients
Beskrivning

Outpatients

Datatyp

boolean

Alias
UMLS CUI [1]
C0029921
2. age: ≥ 40 to < 80
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. hypertension: systolic blood pressure of ≥ 140 mmhg or diastolic blood pressure of ≥
Beskrivning

Hypertensive disease | Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
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.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0580946
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0585941
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.
Beskrivning

Assessment Hypertensive disease | Blood pressure determination | Average Measurement Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0020538
UMLS CUI [2]
C0005824
UMLS CUI [3,1]
C1510992
UMLS CUI [3,2]
C0242485
UMLS CUI [3,3]
C1265611
4. patients who have given consent to participate in the present study.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
cardiovascular risks:
Beskrivning

Cardiovascular risk

Datatyp

boolean

Alias
UMLS CUI [1]
C4324389
1. diabetes mellitus; type 2 diabetes mellitus
Beskrivning

Diabetes Mellitus | Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0011860
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)
Beskrivning

Kidney | Creatinine measurement, serum | Gender | Proteinuria | Chronic kidney disease stage | Glomerular Filtration Rate

Datatyp

boolean

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

Heart | Myocardial Infarction | Angina Pectoris | Heart failure New York Heart Association Classification | Left Ventricular Hypertrophy | Atrial Fibrillation Transient | Persistent atrial fibrillation

Datatyp

boolean

Alias
UMLS CUI [1]
C0018787
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002962
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C1275491
UMLS CUI [5]
C0149721
UMLS CUI [6,1]
C0004238
UMLS CUI [6,2]
C0205374
UMLS CUI [7]
C2585653
4. brain; previous cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient cerebral ischemic attack noted more than 6 months before obtaining the informed consent
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0006104
UMLS CUI [2]
C0007785
UMLS CUI [3]
C2937358
UMLS CUI [4]
C0038525
UMLS CUI [5]
C0007787
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
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C1704436
UMLS CUI [2,1]
C3495795
UMLS CUI [2,2]
C0023216
UMLS CUI [3,1]
C0162577
UMLS CUI [3,2]
C0023216
UMLS CUI [4]
C1276055
UMLS CUI [5]
C0021775
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who meet any of the following criteria will be excluded from the study.
Beskrivning

Criteria Any Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1552551
UMLS CUI [1,3]
C1550543
1. type 1 diabetes mellitus
Beskrivning

Diabetes Mellitus, Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
2. severe renal disorders (serum creatinine of ≥ 2.0 mg/dl)
Beskrivning

Kidney Diseases Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205082
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
Beskrivning

Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery | Blood vessel of lower limb Bypass | Cerebral Infarction | Cerebral Hemorrhage | Subarachnoid Hemorrhage | Transient Ischemic Attack

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C2936173
UMLS CUI [3]
C0010055
UMLS CUI [4,1]
C4517177
UMLS CUI [4,2]
C0741847
UMLS CUI [5]
C0007785
UMLS CUI [6]
C2937358
UMLS CUI [7]
C0038525
UMLS CUI [8]
C0007787
4. diagnosis of heart failure (nyha iii or iv class )
Beskrivning

Heart failure New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
5. virulent hypertension and secondary hypertension
Beskrivning

Other Coding | Secondary hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2]
C0155616
6. pregnant women
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
7. clinically relevant allergic symptoms or past history of hypersensitivity to drugs /
Beskrivning

Drug Allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0013182
significant adverse drug reactions
Beskrivning

Adverse reaction to drug

Datatyp

boolean

Alias
UMLS CUI [1]
C0041755
8. extremely poor bile secretion or serious liver disorders
Beskrivning

Deficiency of bile secretion | Liver diseases Serious

Datatyp

boolean

Alias
UMLS CUI [1]
C3203690
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205404
9. treatment-required malignant tumors
Beskrivning

Malignant Neoplasms Treatment required for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332121
10. patients who are judged by the physician in charge to be ineligible for the study for any other reasons
Beskrivning

Study Subject Participation Status Ineligible

Datatyp

boolean

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

Eligibility Hypertension NCT01075698

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
Kidney | Creatinine measurement, serum | Gender | Proteinuria | Chronic kidney disease stage | Glomerular Filtration Rate
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])
Heart | Myocardial Infarction | Angina Pectoris | Heart failure New York Heart Association Classification | Left Ventricular Hypertrophy | Atrial Fibrillation Transient | Persistent atrial fibrillation
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])
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])
Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery | Blood vessel of lower limb Bypass | Cerebral Infarction | Cerebral Hemorrhage | Subarachnoid Hemorrhage | Transient Ischemic Attack
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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