ID

42628

Description

Atorvastatin in Pulmonary Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00615823

Link

https://clinicaltrials.gov/show/NCT00615823

Keywords

Versions (2)
  1. 3/4/17 3/4/17 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension, Pulmonary NCT00615823

English

Eligibility Hypertension, Pulmonary NCT00615823

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
able to understand and willing to sign the informed consent form
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
<=65 and >=18years old
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of pulmonary arterial hypertension (mean pulmonary artery pressure greater than 25 mm hg at rest with a pulmonary capillary wedge pressure less than 15 mm hg )that is a) idiopathic, b) familial, or c) associated with connective-tissue disease, d)congenital systemic-to-pulmonary shunt occurring after surgical/interventional repair that had been performed at least five years previously or in the absence of indications for surgery/intervention treatment e) chronic thromboembolism pah in the absence of indications for surgery
Description

Pulmonary arterial hypertension; Pulmonary artery mean pressure; Pulmonary Capillary Wedge Pressure | Idiopathic pulmonary hypertension | Familial pulmonary arterial hypertension | Pulmonary arterial hypertension associated with connective tissue disease | Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunt; Surgical repair and revision of shunt | Chronic pulmonary thromboembolism; Surgery not indicated

Data type

boolean

Alias
UMLS CUI [1]
C2973725
UMLS CUI [2,1]
C0428645
UMLS CUI [2,2]
C0086879
UMLS CUI [3]
C0152171
UMLS CUI [4]
C1701939
UMLS CUI [5]
C3697982
UMLS CUI [6,1]
C3698160
UMLS CUI [6,2]
C0185036
UMLS CUI [7,1]
C3873396
UMLS CUI [7,2]
C0420604
patients in who functional class ii to iii
Description

patients in who functional class ii to iii

Data type

boolean

Alias
UMLS CUI [1]
C4087442
UMLS CUI [2]
C4087443
vasodilator testing nonresponders
Description

vasodilator testing nonresponders

Data type

boolean

Alias
UMLS CUI [1,1]
C0042402
UMLS CUI [1,2]
C0919875
baseline six-minute walking distance between 100 and 460 m
Description

six-minute walking distance

Data type

boolean

Alias
UMLS CUI [1]
C0430515
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pah related to other etiologies (groups 2, 3 and 5 pulmonary hypertension)
Description

pah related to other etiologies

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C1314792
a forced expiratory volume in one second/ forced vital capacity below 50% or a total lung capacity of less than 60 percent predicted value
Description

forced expiratory volume in one second (FEV1)% (FEV1/FVC) | Forced vital capacity - finding | Total Lung Capacity

Data type

boolean

Alias
UMLS CUI [1]
C3815113
UMLS CUI [2]
C1287681
UMLS CUI [3]
C0040509
a 6-minute walk distance of less than 100 or more than 460 m
Description

6 minute walk test

Data type

boolean

Alias
UMLS CUI [1]
C0430515
a positive acute vasodilator response
Description

acute vasodilator response

Data type

boolean

Alias
UMLS CUI [1,1]
C0042402
UMLS CUI [1,2]
C0919876
current treatment with calcium-channel blockers or specific therapy (endothelin receptor antagonist, phosphodiesterase-5 inhibitor, or prostacyclin)
Description

Calcium Channel Blockers | Endothelin receptor antagonist | Phosphodiesterase 5 inhibitor | Prostacycline [EPC]

Data type

boolean

Alias
UMLS CUI [1]
C0006684
UMLS CUI [2]
C1134681
UMLS CUI [3]
C1318700
UMLS CUI [4]
C2825061
inability to perform 6-minute walk test
Description

inability to perform 6-minute walk test

Data type

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C0085732
serum transaminase level three times above the upper limit of normal
Description

serum transaminase level

Data type

boolean

Alias
UMLS CUI [1]
C0850712
creatine kinase level five times above the upper limit of normal
Description

creatine kinase

Data type

boolean

Alias
UMLS CUI [1]
C0201973
previously diagnosed heart disease such as serious cardiac arrhythmias, unstable angina pectoris, myocardial infarction
Description

heart disease such as serious cardiac arrhythmias, unstable angina pectoris, myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0027051
history of transient ischemia attack or stroke within three months
Description

Transient Ischemic Attack | Cerebrovascular accident | Medical History

Data type

boolean

Alias
UMLS CUI [1]
C0007787
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0262926
bleeding disorder
Description

bleeding disorder

Data type

boolean

Alias
UMLS CUI [1]
C0005779
positive pregnancy test or breastfeeding practice
Description

pregnancy, breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history or suspicion of inability to cooperate
Description

limited compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
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Similar models

Eligibility Hypertension, Pulmonary NCT00615823

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
able to understand and willing to sign the informed consent form
boolean
C0021430 (UMLS CUI [1])
age
Item
<=65 and >=18years old
boolean
C0001779 (UMLS CUI [1])
Pulmonary arterial hypertension; Pulmonary artery mean pressure; Pulmonary Capillary Wedge Pressure | Idiopathic pulmonary hypertension | Familial pulmonary arterial hypertension | Pulmonary arterial hypertension associated with connective tissue disease | Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunt; Surgical repair and revision of shunt | Chronic pulmonary thromboembolism; Surgery not indicated
Item
diagnosis of pulmonary arterial hypertension (mean pulmonary artery pressure greater than 25 mm hg at rest with a pulmonary capillary wedge pressure less than 15 mm hg )that is a) idiopathic, b) familial, or c) associated with connective-tissue disease, d)congenital systemic-to-pulmonary shunt occurring after surgical/interventional repair that had been performed at least five years previously or in the absence of indications for surgery/intervention treatment e) chronic thromboembolism pah in the absence of indications for surgery
boolean
C2973725 (UMLS CUI [1])
C0428645 (UMLS CUI [2,1])
C0086879 (UMLS CUI [2,2])
C0152171 (UMLS CUI [3])
C1701939 (UMLS CUI [4])
C3697982 (UMLS CUI [5])
C3698160 (UMLS CUI [6,1])
C0185036 (UMLS CUI [6,2])
C3873396 (UMLS CUI [7,1])
C0420604 (UMLS CUI [7,2])
patients in who functional class ii to iii
Item
patients in who functional class ii to iii
boolean
C4087442 (UMLS CUI [1])
C4087443 (UMLS CUI [2])
vasodilator testing nonresponders
Item
vasodilator testing nonresponders
boolean
C0042402 (UMLS CUI [1,1])
C0919875 (UMLS CUI [1,2])
six-minute walking distance
Item
baseline six-minute walking distance between 100 and 460 m
boolean
C0430515 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pah related to other etiologies
Item
pah related to other etiologies (groups 2, 3 and 5 pulmonary hypertension)
boolean
C2973725 (UMLS CUI [1,1])
C1314792 (UMLS CUI [1,2])
forced expiratory volume in one second (FEV1)% (FEV1/FVC) | Forced vital capacity - finding | Total Lung Capacity
Item
a forced expiratory volume in one second/ forced vital capacity below 50% or a total lung capacity of less than 60 percent predicted value
boolean
C3815113 (UMLS CUI [1])
C1287681 (UMLS CUI [2])
C0040509 (UMLS CUI [3])
6 minute walk test
Item
a 6-minute walk distance of less than 100 or more than 460 m
boolean
C0430515 (UMLS CUI [1])
acute vasodilator response
Item
a positive acute vasodilator response
boolean
C0042402 (UMLS CUI [1,1])
C0919876 (UMLS CUI [1,2])
Calcium Channel Blockers | Endothelin receptor antagonist | Phosphodiesterase 5 inhibitor | Prostacycline [EPC]
Item
current treatment with calcium-channel blockers or specific therapy (endothelin receptor antagonist, phosphodiesterase-5 inhibitor, or prostacyclin)
boolean
C0006684 (UMLS CUI [1])
C1134681 (UMLS CUI [2])
C1318700 (UMLS CUI [3])
C2825061 (UMLS CUI [4])
inability to perform 6-minute walk test
Item
inability to perform 6-minute walk test
boolean
C0430515 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
serum transaminase level
Item
serum transaminase level three times above the upper limit of normal
boolean
C0850712 (UMLS CUI [1])
creatine kinase
Item
creatine kinase level five times above the upper limit of normal
boolean
C0201973 (UMLS CUI [1])
heart disease such as serious cardiac arrhythmias, unstable angina pectoris, myocardial infarction
Item
previously diagnosed heart disease such as serious cardiac arrhythmias, unstable angina pectoris, myocardial infarction
boolean
C0018799 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Transient Ischemic Attack | Cerebrovascular accident | Medical History
Item
history of transient ischemia attack or stroke within three months
boolean
C0007787 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
bleeding disorder
Item
bleeding disorder
boolean
C0005779 (UMLS CUI [1])
pregnancy, breast feeding
Item
positive pregnancy test or breastfeeding practice
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
limited compliance
Item
history or suspicion of inability to cooperate
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
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