ID

42628

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00615823

Trefwoorden

Versies (2)
  1. 04-03-17 04-03-17 -
  2. 17-09-21 17-09-21 -
Geüploaded op

17 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypertension, Pulmonary NCT00615823

Engels

Eligibility Hypertension, Pulmonary NCT00615823

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

informed consent

Datatype

boolean

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

age

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

patients in who functional class ii to iii

Datatype

boolean

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

vasodilator testing nonresponders

Datatype

boolean

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

six-minute walking distance

Datatype

boolean

Alias
UMLS CUI [1]
C0430515
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

pah related to other etiologies

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

6 minute walk test

Datatype

boolean

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

acute vasodilator response

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

inability to perform 6-minute walk test

Datatype

boolean

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

serum transaminase level

Datatype

boolean

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

creatine kinase

Datatype

boolean

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

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

Datatype

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
Beschrijving

Transient Ischemic Attack | Cerebrovascular accident | Medical History

Datatype

boolean

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

bleeding disorder

Datatype

boolean

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

pregnancy, breast feeding

Datatype

boolean

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

limited compliance

Datatype

boolean

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

Eligibility Hypertension, Pulmonary NCT00615823

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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