ID

36980

Descrição

TReatment Of Pulmonary HYpertension 1 Study; ODM derived from: https://clinicaltrials.gov/show/NCT02516722

Link

https://clinicaltrials.gov/show/NCT02516722

Palavras-chave

Versões (1)
  1. 26/06/2019 26/06/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

26 de junho de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT02516722

Inglês

Eligibility Pulmonary Arterial Hypertension NCT02516722

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient with known pulmonary arterial hypertension (pah), which has been diagnosed as idiopathic pah, connective tissue disease pah, anorexogen induced or familial pah
Descrição

Pulmonary arterial hypertension | Idiopathic pulmonary hypertension | Pulmonary arterial hypertension Associated with Connective Tissue Disease | Pulmonary arterial hypertension Anorexigenic drug Induced | Familial pulmonary hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2973725
UMLS CUI [2]
C0152171
UMLS CUI [3,1]
C2973725
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0009782
UMLS CUI [4,1]
C2973725
UMLS CUI [4,2]
C0003620
UMLS CUI [4,3]
C0205263
UMLS CUI [5]
C0340543
pah diagnosis confirmed by hemodynamic evaluation performed prior to screening and showing all of the following: mean pulmonary artery pressure (mpap) ≥25 mmhg at rest; pulmonary capillary wedge pressure (pcwp) or left ventricular end diastolic pressure (lvedp) ≤15 mmhg; pulmonary vascular resistance (pvr) at rest >3 wood units; not meeting the criteria for a positive vasodilator response (fall in mpap ≥ 10 mmhg to ≤
Descrição

Pulmonary arterial hypertension Evaluation Hemodynamic | Mean pulmonary arterial pressure At rest | Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure level | Pulmonary Vascular Resistance At rest | Criteria failed | Vasodilator Response Positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C1261322
UMLS CUI [1,3]
C0019010
UMLS CUI [2,1]
C3854605
UMLS CUI [2,2]
C0443144
UMLS CUI [3]
C0086879
UMLS CUI [4]
C0456190
UMLS CUI [5,1]
C0456261
UMLS CUI [5,2]
C0443144
UMLS CUI [6,1]
C0243161
UMLS CUI [6,2]
C0231175
UMLS CUI [7,1]
C0042402
UMLS CUI [7,2]
C1704632
UMLS CUI [7,3]
C1514241
40 mmhg).
Descrição

ID.3

Tipo de dados

boolean

patient with a current diagnosis of who functional class iii
Descrição

WHO classification Functional Status Class

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4267671
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
patient should be on two pulmonary arterial hypertension specific medications other than parenteral prostanoids
Descrição

Pulmonary arterial hypertension | Pharmaceutical Preparations Specific Quantity | Exception Prostaglandins Parenteral

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2973725
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0205369
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0033554
UMLS CUI [3,3]
C1518896
patient is adhering to a stable drug regimen (i.e., with no changes of dose or medication for a minimum of 3 months prior to enrollment)
Descrição

Pharmacotherapy Stable | Drug dosage unchanged | Change of medication Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0870450
UMLS CUI [2,2]
C0442739
UMLS CUI [3,1]
C0580105
UMLS CUI [3,2]
C0332197
patient with egfr levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂
Descrição

Estimated Glomerular Filtration Rate | Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3811844
UMLS CUI [2]
C0201976
150µmol/l
Descrição

ID.8

Tipo de dados

boolean

Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient who are treated with parenteral prostanoids
Descrição

Prostaglandins Parenteral

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0033554
UMLS CUI [1,2]
C1518896
pregnant women or women planning a pregnancy within 12 months of study enrolment
Descrição

Pregnancy | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
patient with significant co-morbid conditions which, at the discretion of the pi, are deemed to prohibit study entry
Descrição

Comorbidity Study Subject Participation Status Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
patient with life expectancy of less than a year
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
concurrent enrollment in another device or drug trial except for observational studies (unless specifically approved by the sponsor)
Descrição

Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs | Exception Observational Study

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0013230
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1518527
patient with pulmonary artery anatomy that precludes treatment
Descrição

Pulmonary artery Anatomic structure Excludes Therapeutic procedure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0034052
UMLS CUI [1,2]
C0700276
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0087111
patient with moderate to severe pulmonary artery stenosis
Descrição

Pulmonary artery stenosis Moderate | Pulmonary artery stenosis Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0238397
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0238397
UMLS CUI [2,2]
C0205082
patient with any pulmonary artery aneurysm
Descrição

Pulmonary artery aneurysm

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0155676
patient who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months
Descrição

Myocardial Infarction | Angina, Unstable | Cerebrovascular accident

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0038454
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Similar models

Eligibility Pulmonary Arterial Hypertension NCT02516722

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Pulmonary arterial hypertension | Idiopathic pulmonary hypertension | Pulmonary arterial hypertension Associated with Connective Tissue Disease | Pulmonary arterial hypertension Anorexigenic drug Induced | Familial pulmonary hypertension
Item
patient with known pulmonary arterial hypertension (pah), which has been diagnosed as idiopathic pah, connective tissue disease pah, anorexogen induced or familial pah
boolean
C2973725 (UMLS CUI [1])
C0152171 (UMLS CUI [2])
C2973725 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0009782 (UMLS CUI [3,3])
C2973725 (UMLS CUI [4,1])
C0003620 (UMLS CUI [4,2])
C0205263 (UMLS CUI [4,3])
C0340543 (UMLS CUI [5])
Pulmonary arterial hypertension Evaluation Hemodynamic | Mean pulmonary arterial pressure At rest | Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure level | Pulmonary Vascular Resistance At rest | Criteria failed | Vasodilator Response Positive
Item
pah diagnosis confirmed by hemodynamic evaluation performed prior to screening and showing all of the following: mean pulmonary artery pressure (mpap) ≥25 mmhg at rest; pulmonary capillary wedge pressure (pcwp) or left ventricular end diastolic pressure (lvedp) ≤15 mmhg; pulmonary vascular resistance (pvr) at rest >3 wood units; not meeting the criteria for a positive vasodilator response (fall in mpap ≥ 10 mmhg to ≤
boolean
C2973725 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C0019010 (UMLS CUI [1,3])
C3854605 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
C0086879 (UMLS CUI [3])
C0456190 (UMLS CUI [4])
C0456261 (UMLS CUI [5,1])
C0443144 (UMLS CUI [5,2])
C0243161 (UMLS CUI [6,1])
C0231175 (UMLS CUI [6,2])
C0042402 (UMLS CUI [7,1])
C1704632 (UMLS CUI [7,2])
C1514241 (UMLS CUI [7,3])
ID.3
Item
40 mmhg).
boolean
WHO classification Functional Status Class
Item
patient with a current diagnosis of who functional class iii
boolean
C4267671 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Pulmonary arterial hypertension | Pharmaceutical Preparations Specific Quantity | Exception Prostaglandins Parenteral
Item
patient should be on two pulmonary arterial hypertension specific medications other than parenteral prostanoids
boolean
C2973725 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0033554 (UMLS CUI [3,2])
C1518896 (UMLS CUI [3,3])
Pharmacotherapy Stable | Drug dosage unchanged | Change of medication Absent
Item
patient is adhering to a stable drug regimen (i.e., with no changes of dose or medication for a minimum of 3 months prior to enrollment)
boolean
C0013216 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0870450 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C0580105 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Estimated Glomerular Filtration Rate | Creatinine measurement, serum
Item
patient with egfr levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂
boolean
C3811844 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
ID.8
Item
150µmol/l
boolean
Item Group
C0680251 (UMLS CUI)
Prostaglandins Parenteral
Item
patient who are treated with parenteral prostanoids
boolean
C0033554 (UMLS CUI [1,1])
C1518896 (UMLS CUI [1,2])
Pregnancy | Pregnancy, Planned
Item
pregnant women or women planning a pregnancy within 12 months of study enrolment
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Comorbidity Study Subject Participation Status Excluded
Item
patient with significant co-morbid conditions which, at the discretion of the pi, are deemed to prohibit study entry
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
Life Expectancy
Item
patient with life expectancy of less than a year
boolean
C0023671 (UMLS CUI [1])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs | Exception Observational Study
Item
concurrent enrollment in another device or drug trial except for observational studies (unless specifically approved by the sponsor)
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C1518527 (UMLS CUI [4,2])
Pulmonary artery Anatomic structure Excludes Therapeutic procedure
Item
patient with pulmonary artery anatomy that precludes treatment
boolean
C0034052 (UMLS CUI [1,1])
C0700276 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Pulmonary artery stenosis Moderate | Pulmonary artery stenosis Severe
Item
patient with moderate to severe pulmonary artery stenosis
boolean
C0238397 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0238397 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Pulmonary artery aneurysm
Item
patient with any pulmonary artery aneurysm
boolean
C0155676 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Cerebrovascular accident
Item
patient who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
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