ID

36567

Description

Imaging Control Study, 3D Echo, MR and RHC.; ODM derived from: https://clinicaltrials.gov/show/NCT02198456

Link

https://clinicaltrials.gov/show/NCT02198456

Keywords

Versions (2)
  1. 1/19/19 1/19/19 -
  2. 5/22/19 5/22/19 -
Copyright Holder

Regina Steringer-Mascherbauer, Elisabethinen Hospital Linz

Uploaded on

May 22, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Imaging in Pulmonary Arterial Hypertension NCT02198456

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >17
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
pulmonary arterial hypertension WHO group I who are going to start a therapy with prostanoid
Description

pulmonary arterial hypertension (WHO grouping) starting prostanoid therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C4267671
UMLS CUI [2,1]
C1704686
UMLS CUI [2,2]
C0033554
written informed consent
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
prostanoid naive
Description

prostanoid naive

Data type

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0033554
no change of the pulmonary arterial hypertension therapy within 3 weeks of inclusion into the study
Description

no change of the pulmonary arterial hypertension therapy soon after inclusion in study

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0332282
UMLS CUI [1,5]
C2603343
UMLS CUI [1,6]
C1512693
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy and lactation period
Description

pregnancy and lactation period

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential who do not use an effective and secure method for birth control
Description

women of childbearing potential who do not use an effective and secure method for birth control

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0700589
severe chronic kidney insufficiency (glomerular filtration rate <30), which will remain for more than 3 months
Description

persistent severe chronic kidney insufficiency (by GFR)

Data type

boolean

Alias
UMLS CUI [1,1]
C0205082
UMLS CUI [1,2]
C0403447
UMLS CUI [1,3]
C0449238
UMLS CUI [2]
C0017654
liver insufficiency child C
Description

liver insufficiency (Child-Pugh class)

Data type

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C4055253
life expectancy shorter than the course of the study (for example because of a malignant disease)
Description

limited life expectancy (for example because of a malignant disease)

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0439801
UMLS CUI [2]
C0006826
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >17
boolean
C0001779 (UMLS CUI [1])
pulmonary arterial hypertension (WHO grouping) starting prostanoid therapy
Item
pulmonary arterial hypertension WHO group I who are going to start a therapy with prostanoid
boolean
C2973725 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
C1704686 (UMLS CUI [2,1])
C0033554 (UMLS CUI [2,2])
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
prostanoid naive
Item
prostanoid naive
boolean
C0919936 (UMLS CUI [1,1])
C0033554 (UMLS CUI [1,2])
no change of the pulmonary arterial hypertension therapy soon after inclusion in study
Item
no change of the pulmonary arterial hypertension therapy within 3 weeks of inclusion into the study
boolean
C2973725 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0332282 (UMLS CUI [1,4])
C2603343 (UMLS CUI [1,5])
C1512693 (UMLS CUI [1,6])
Item Group
C0680251 (UMLS CUI)
pregnancy and lactation period
Item
pregnancy and lactation period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
women of childbearing potential who do not use an effective and secure method for birth control
Item
women of childbearing potential who do not use an effective and secure method for birth control
boolean
C3831118 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
persistent severe chronic kidney insufficiency (by GFR)
Item
severe chronic kidney insufficiency (glomerular filtration rate <30), which will remain for more than 3 months
boolean
C0205082 (UMLS CUI [1,1])
C0403447 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0017654 (UMLS CUI [2])
liver insufficiency (Child-Pugh class)
Item
liver insufficiency child C
boolean
C1306571 (UMLS CUI [1])
C4055253 (UMLS CUI [2])
limited life expectancy (for example because of a malignant disease)
Item
life expectancy shorter than the course of the study (for example because of a malignant disease)
boolean
C0023671 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
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