ID

31531

Description

China Stroke Primary Prevention Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00794885

Link

https://clinicaltrials.gov/show/NCT00794885

Keywords

Versions (1)
  1. 9/1/18 9/1/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 1, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Primary Hypertension NCT00794885

English

Eligibility Primary Hypertension NCT00794885

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
bp≥140/90 mmhg in both of the two screening visits or currently under anti-hypertension treatment
Description

Blood pressure determination | Antihypertensive therapy

Data type

boolean

Alias
UMLS CUI [1]
C0005824
UMLS CUI [2]
C0585941
45 - 75 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
successful determination of mthfr c677t genotype
Description

MTHFR c677t Genotype determination

Data type

boolean

Alias
UMLS CUI [1,1]
C0943672
UMLS CUI [1,2]
C1285573
for pre-menopausal women, agreed to use contraceptives during the trial
Description

Premenopausal state Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0700589
signed the written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
having a history of stroke
Description

Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0038454
having a history of myocardial infarction
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
having a history of physician diagnosed heart failure
Description

Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018801
post- coronary revascularization
Description

Status post Coronary revascularisation

Data type

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0877341
severe somatic disease such as cancer
Description

Disease Somatic Severe | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2986476
UMLS CUI [1,3]
C0205082
UMLS CUI [2]
C0006826
secondary hypertension
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
congenital or acquired organic heart diseases
Description

Organic heart disease Congenital | Organic heart disease Acquired

Data type

boolean

Alias
UMLS CUI [1,1]
C0747057
UMLS CUI [1,2]
C1744681
UMLS CUI [2,1]
C0747057
UMLS CUI [2,2]
C0439661
contraindicated to angiotensin-converting enzyme inhibitor(acei)
Description

Medical contraindication Angiotensin-Converting Enzyme Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003015
history of acei adverse effects
Description

Adverse effects ACEI

Data type

boolean

Alias
UMLS CUI [1,1]
C0879626
UMLS CUI [1,2]
C0003015
currently long-term use of folic acid or vitamin b12 or vitamin b6
Description

Folic Acid Long-term | Vitamin B 12 Long-term | Vitamin B6 Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C0016410
UMLS CUI [1,2]
C0443252
UMLS CUI [2,1]
C0042845
UMLS CUI [2,2]
C0443252
UMLS CUI [3,1]
C0087162
UMLS CUI [3,2]
C0443252
pregnant or child breastfeeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
severe mental disorders
Description

Mental Disorders, Severe

Data type

boolean

Alias
UMLS CUI [1]
C4046029
lab tests indicating abnormal liver or kidney function
Description

Liver Dysfunction Laboratory Procedures | Abnormal renal function Laboratory Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0022885
UMLS CUI [2,1]
C0151746
UMLS CUI [2,2]
C0022885
unwilling to participate the trial, unwilling to change the current antihypertensive treatment
Description

Study Subject Participation Status Unwilling | Antihypertensive therapy Change Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0585941
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0558080
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Similar models

Eligibility Primary Hypertension NCT00794885

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Blood pressure determination | Antihypertensive therapy
Item
bp≥140/90 mmhg in both of the two screening visits or currently under anti-hypertension treatment
boolean
C0005824 (UMLS CUI [1])
C0585941 (UMLS CUI [2])
Age
Item
45 - 75 years old
boolean
C0001779 (UMLS CUI [1])
MTHFR c677t Genotype determination
Item
successful determination of mthfr c677t genotype
boolean
C0943672 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
Premenopausal state Contraceptive methods
Item
for pre-menopausal women, agreed to use contraceptives during the trial
boolean
C0232969 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
signed the written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cerebrovascular accident
Item
having a history of stroke
boolean
C0038454 (UMLS CUI [1])
Myocardial Infarction
Item
having a history of myocardial infarction
boolean
C0027051 (UMLS CUI [1])
Heart failure
Item
having a history of physician diagnosed heart failure
boolean
C0018801 (UMLS CUI [1])
Status post Coronary revascularisation
Item
post- coronary revascularization
boolean
C0231290 (UMLS CUI [1,1])
C0877341 (UMLS CUI [1,2])
Disease Somatic Severe | Malignant Neoplasms
Item
severe somatic disease such as cancer
boolean
C0012634 (UMLS CUI [1,1])
C2986476 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2])
Secondary hypertension
Item
secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Organic heart disease Congenital | Organic heart disease Acquired
Item
congenital or acquired organic heart diseases
boolean
C0747057 (UMLS CUI [1,1])
C1744681 (UMLS CUI [1,2])
C0747057 (UMLS CUI [2,1])
C0439661 (UMLS CUI [2,2])
Medical contraindication Angiotensin-Converting Enzyme Inhibitors
Item
contraindicated to angiotensin-converting enzyme inhibitor(acei)
boolean
C1301624 (UMLS CUI [1,1])
C0003015 (UMLS CUI [1,2])
Adverse effects ACEI
Item
history of acei adverse effects
boolean
C0879626 (UMLS CUI [1,1])
C0003015 (UMLS CUI [1,2])
Folic Acid Long-term | Vitamin B 12 Long-term | Vitamin B6 Long-term
Item
currently long-term use of folic acid or vitamin b12 or vitamin b6
boolean
C0016410 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C0042845 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
C0087162 (UMLS CUI [3,1])
C0443252 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or child breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental Disorders, Severe
Item
severe mental disorders
boolean
C4046029 (UMLS CUI [1])
Liver Dysfunction Laboratory Procedures | Abnormal renal function Laboratory Procedures
Item
lab tests indicating abnormal liver or kidney function
boolean
C0086565 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0151746 (UMLS CUI [2,1])
C0022885 (UMLS CUI [2,2])
Study Subject Participation Status Unwilling | Antihypertensive therapy Change Unwilling
Item
unwilling to participate the trial, unwilling to change the current antihypertensive treatment
boolean
C2348568 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0585941 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
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