ID

35351

Beschrijving

U.S. CTEPH Registry; ODM derived from: https://clinicaltrials.gov/show/NCT02429284

Link

https://clinicaltrials.gov/show/NCT02429284

Trefwoorden

Versies (1)
  1. 01-03-19 01-03-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

1 maart 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Chronic Thromboembolic Pulmonary Hypertension (CTEPH) NCT02429284

Engels

Eligibility Chronic Thromboembolic Pulmonary Hypertension (CTEPH) NCT02429284

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be a permanent resident of the united states
Beschrijving

Resident United States

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347958
UMLS CUI [1,2]
C0041703
documentation of the following hemodynamic parameters by right heart catheterization
Beschrijving

Hemodynamics Parameters Catheterization of right heart

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019010
UMLS CUI [1,2]
C0449381
UMLS CUI [1,3]
C0189896
mean pulmonary arterial pressure (papm) ≥ 25 mm hg at rest and,
Beschrijving

Mean pulmonary arterial pressure At rest

Datatype

boolean

Alias
UMLS CUI [1,1]
C3854605
UMLS CUI [1,2]
C0443144
pulmonary artery wedge pressure (pawp) ≤ 15 mm hg (or > 15 mmhg if justified)
Beschrijving

Pulmonary Wedge Pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0034094
radiologic confirmation that chronic thromboembolic disease is the cause of the pulmonary hypertension by
Beschrijving

Thromboembolism chronic Cause Pulmonary Hypertension | Diagnostic radiologic examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040038
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0020542
UMLS CUI [2]
C0043299
one or more mismatched perfusion defect(s) by lung ventilation/perfusion scan, and
Beschrijving

Mismatch Lung perfusion defect Quantity Ventilation perfusion scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C1881865
UMLS CUI [1,2]
C4028623
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0560738
confirmation of chronic thromboembolic disease by evidence of bands/webs, vessel narrowing or occlusion seen on ct pulmonary angiogram (cta), conventional angiography or mr angiography (mra).
Beschrijving

Thromboembolism chronic | Pulmonary artery band | Vascular stenosis CT pulmonary angiogram | Vessel occlusion CT pulmonary angiogram | Vascular stenosis Angiography | Vessel occlusion Angiography | Vascular stenosis Magnetic Resonance Angiography | Vessel occlusion Magnetic Resonance Angiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040038
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C2022612
UMLS CUI [3,1]
C0679403
UMLS CUI [3,2]
C4286018
UMLS CUI [4,1]
C1386685
UMLS CUI [4,2]
C4286018
UMLS CUI [5,1]
C0679403
UMLS CUI [5,2]
C0002978
UMLS CUI [6,1]
C1386685
UMLS CUI [6,2]
C0002978
UMLS CUI [7,1]
C0679403
UMLS CUI [7,2]
C0243032
UMLS CUI [8,1]
C1386685
UMLS CUI [8,2]
C0243032
patients must be diagnosed with cteph within 6 months of being considered for study eligibility (signing of consent to participate). the date of diagnosis will be defined as when both hemodynamic criteria have been met and chronic thromboembolic disease is confirmed to be the cause of the pulmonary hypertension by an abnormal v/q scan and the presence of chronic thromboembolic disease on cta, mra or pulmonary angiography. hemodynamic and radiologic criteria can be met at separate time points; the most recently met criteria time point will be defined as the date of diagnosis.
Beschrijving

Chronic thromboembolic pulmonary hypertension | Thromboembolism chronic Cause Pulmonary Hypertension | V/Q scan Abnormal | Thromboembolism chronic CT pulmonary angiogram | Thromboembolism chronic Magnetic Resonance Angiography | Thromboembolism chronic Pulmonary angiography

Datatype

boolean

Alias
UMLS CUI [1]
C2363973
UMLS CUI [2,1]
C0040038
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0015127
UMLS CUI [2,4]
C0020542
UMLS CUI [3,1]
C0560738
UMLS CUI [3,2]
C0205161
UMLS CUI [4,1]
C0040038
UMLS CUI [4,2]
C0205191
UMLS CUI [4,3]
C4286018
UMLS CUI [5,1]
C0040038
UMLS CUI [5,2]
C0205191
UMLS CUI [5,3]
C0243032
UMLS CUI [6,1]
C0040038
UMLS CUI [6,2]
C0205191
UMLS CUI [6,3]
C0677490
prior to enrollment all subjects must have the diagnosis of cteph confirmed by the adjudication committee.
Beschrijving

Chronic thromboembolic pulmonary hypertension Confirmed by Adjudication Committee

Datatype

boolean

Alias
UMLS CUI [1,1]
C2363973
UMLS CUI [1,2]
C0521093
UMLS CUI [1,3]
C2700368
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients unwilling or unable to provide written consent for participation in the study. appropriate surrogate consent will be obtained for pediatric patients as defined by each investigational site's irb.
Beschrijving

Informed Consent Unwilling | Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
patients with an underlying medical disorder with an anticipated life expectancy less than 2 years.
Beschrijving

Primary disorder | Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0277554
UMLS CUI [2]
C0023671
patients who do not meet inclusion criteria including:
Beschrijving

Lacking Inclusion criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C1512693
UMLS CUI [1,3]
C1550543
have not had documentation of hemodynamic criteria by right heart catheterization as outlined in the inclusion criteria
Beschrijving

Hemodynamics criteria Absent Catheterization of right heart

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019010
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C0332197
UMLS CUI [1,4]
C0189896
do not have radiologic confirmation of chronic thromboembolic disease as outlined in the inclusion criteria
Beschrijving

Thromboembolism chronic | Diagnostic radiologic examination Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040038
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0043299
UMLS CUI [2,2]
C0332197
meet the criteria for inclusion into who groups i, ii, iii, or v
Beschrijving

Inclusion criteria Fulfill WHO Groups

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0043237
UMLS CUI [1,4]
C0441833
Terug naar het begin van de pagina

Similar models

Eligibility Chronic Thromboembolic Pulmonary Hypertension (CTEPH) NCT02429284

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Resident United States
Item
patients must be a permanent resident of the united states
boolean
C2347958 (UMLS CUI [1,1])
C0041703 (UMLS CUI [1,2])
Hemodynamics Parameters Catheterization of right heart
Item
documentation of the following hemodynamic parameters by right heart catheterization
boolean
C0019010 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
C0189896 (UMLS CUI [1,3])
Mean pulmonary arterial pressure At rest
Item
mean pulmonary arterial pressure (papm) ≥ 25 mm hg at rest and,
boolean
C3854605 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
Pulmonary Wedge Pressure
Item
pulmonary artery wedge pressure (pawp) ≤ 15 mm hg (or > 15 mmhg if justified)
boolean
C0034094 (UMLS CUI [1])
Thromboembolism chronic Cause Pulmonary Hypertension | Diagnostic radiologic examination
Item
radiologic confirmation that chronic thromboembolic disease is the cause of the pulmonary hypertension by
boolean
C0040038 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0020542 (UMLS CUI [1,4])
C0043299 (UMLS CUI [2])
Mismatch Lung perfusion defect Quantity Ventilation perfusion scan
Item
one or more mismatched perfusion defect(s) by lung ventilation/perfusion scan, and
boolean
C1881865 (UMLS CUI [1,1])
C4028623 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0560738 (UMLS CUI [1,4])
Thromboembolism chronic | Pulmonary artery band | Vascular stenosis CT pulmonary angiogram | Vessel occlusion CT pulmonary angiogram | Vascular stenosis Angiography | Vessel occlusion Angiography | Vascular stenosis Magnetic Resonance Angiography | Vessel occlusion Magnetic Resonance Angiography
Item
confirmation of chronic thromboembolic disease by evidence of bands/webs, vessel narrowing or occlusion seen on ct pulmonary angiogram (cta), conventional angiography or mr angiography (mra).
boolean
C0040038 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C2022612 (UMLS CUI [2])
C0679403 (UMLS CUI [3,1])
C4286018 (UMLS CUI [3,2])
C1386685 (UMLS CUI [4,1])
C4286018 (UMLS CUI [4,2])
C0679403 (UMLS CUI [5,1])
C0002978 (UMLS CUI [5,2])
C1386685 (UMLS CUI [6,1])
C0002978 (UMLS CUI [6,2])
C0679403 (UMLS CUI [7,1])
C0243032 (UMLS CUI [7,2])
C1386685 (UMLS CUI [8,1])
C0243032 (UMLS CUI [8,2])
Chronic thromboembolic pulmonary hypertension | Thromboembolism chronic Cause Pulmonary Hypertension | V/Q scan Abnormal | Thromboembolism chronic CT pulmonary angiogram | Thromboembolism chronic Magnetic Resonance Angiography | Thromboembolism chronic Pulmonary angiography
Item
patients must be diagnosed with cteph within 6 months of being considered for study eligibility (signing of consent to participate). the date of diagnosis will be defined as when both hemodynamic criteria have been met and chronic thromboembolic disease is confirmed to be the cause of the pulmonary hypertension by an abnormal v/q scan and the presence of chronic thromboembolic disease on cta, mra or pulmonary angiography. hemodynamic and radiologic criteria can be met at separate time points; the most recently met criteria time point will be defined as the date of diagnosis.
boolean
C2363973 (UMLS CUI [1])
C0040038 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0015127 (UMLS CUI [2,3])
C0020542 (UMLS CUI [2,4])
C0560738 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
C0040038 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C4286018 (UMLS CUI [4,3])
C0040038 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
C0243032 (UMLS CUI [5,3])
C0040038 (UMLS CUI [6,1])
C0205191 (UMLS CUI [6,2])
C0677490 (UMLS CUI [6,3])
Chronic thromboembolic pulmonary hypertension Confirmed by Adjudication Committee
Item
prior to enrollment all subjects must have the diagnosis of cteph confirmed by the adjudication committee.
boolean
C2363973 (UMLS CUI [1,1])
C0521093 (UMLS CUI [1,2])
C2700368 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unwilling | Informed Consent Unable
Item
patients unwilling or unable to provide written consent for participation in the study. appropriate surrogate consent will be obtained for pediatric patients as defined by each investigational site's irb.
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Primary disorder | Life Expectancy
Item
patients with an underlying medical disorder with an anticipated life expectancy less than 2 years.
boolean
C0277554 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Lacking Inclusion criteria Fulfill
Item
patients who do not meet inclusion criteria including:
boolean
C0332268 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Hemodynamics criteria Absent Catheterization of right heart
Item
have not had documentation of hemodynamic criteria by right heart catheterization as outlined in the inclusion criteria
boolean
C0019010 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0189896 (UMLS CUI [1,4])
Thromboembolism chronic | Diagnostic radiologic examination Absent
Item
do not have radiologic confirmation of chronic thromboembolic disease as outlined in the inclusion criteria
boolean
C0040038 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0043299 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Inclusion criteria Fulfill WHO Groups
Item
meet the criteria for inclusion into who groups i, ii, iii, or v
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0043237 (UMLS CUI [1,3])
C0441833 (UMLS CUI [1,4])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial