ID

35351

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02429284

Stichworte

Versionen (1)
  1. 01.03.19 01.03.19 -
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1. März 2019

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Eligibility Chronic Thromboembolic Pulmonary Hypertension (CTEPH) NCT02429284

Englisch

Eligibility Chronic Thromboembolic Pulmonary Hypertension (CTEPH) NCT02429284

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Resident United States

Datentyp

boolean

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

Hemodynamics Parameters Catheterization of right heart

Datentyp

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,
Beschreibung

Mean pulmonary arterial pressure At rest

Datentyp

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)
Beschreibung

Pulmonary Wedge Pressure

Datentyp

boolean

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

Thromboembolism chronic Cause Pulmonary Hypertension | Diagnostic radiologic examination

Datentyp

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
Beschreibung

Mismatch Lung perfusion defect Quantity Ventilation perfusion scan

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Chronic thromboembolic pulmonary hypertension Confirmed by Adjudication Committee

Datentyp

boolean

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

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.
Beschreibung

Informed Consent Unwilling | Informed Consent Unable

Datentyp

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.
Beschreibung

Primary disorder | Life Expectancy

Datentyp

boolean

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

Lacking Inclusion criteria Fulfill

Datentyp

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
Beschreibung

Hemodynamics criteria Absent Catheterization of right heart

Datentyp

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
Beschreibung

Thromboembolism chronic | Diagnostic radiologic examination Absent

Datentyp

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
Beschreibung

Inclusion criteria Fulfill WHO Groups

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0043237
UMLS CUI [1,4]
C0441833
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Ähnliche Modelle

Eligibility Chronic Thromboembolic Pulmonary Hypertension (CTEPH) NCT02429284

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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