ID

17227

Description

Multi-center, Web Based Observational Study of Pulmonary Hypertension in Scleroderma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00377949

Link

https://clinicaltrials.gov/show/NCT00377949

Keywords

Versions (1)
  1. 9/1/16 9/1/16 -
Uploaded on

September 1, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Systemic Sclerosis NCT00377949

English

Eligibility Systemic Sclerosis NCT00377949

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
eligible patients must meet all of the following inclusion criteria:
Description

Inclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
patient ≥ 18 years with a clinical diagnosis of ssc (acr criteria or the leroy criteria for limited or diffuse scleroderma
Description

Age; Systemic Scleroderma

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0036421
2. specific inclusion criteria
Description

Inclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
diagnosis of "pre" pulmonary arterial hypertension defined as:
Description

"pre" pulmonary arterial hypertension

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C1696708
echocardiogram with a resting spap of ≥ 40mmhg or
Description

sPAP

Data type

boolean

Alias
UMLS CUI [1]
C0428643
pulmonary function test with fvc >70% and a dlco <55% of predicted or a fvc/dlco ratio >1.6. or
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1]
C3714541
UMLS CUI [2]
C1516251
right heart catheterization which shows or a mean pa pressure > 30mmhg with exercise (with a mpap < 25mmhg at rest)
Description

Mean pulmonary arterial pressure

Data type

boolean

Alias
UMLS CUI [1]
C2008312
patients entered as a 'pre'-pulmonary arterial hypertension who then undergo right heart catheterization and are found to have pulmonary arterial hypertension, pulmonary venous hypertension or diastolic dysfunction or pulmonary hypertension secondary to interstitial lung disease will be followed as a definite ph patient and classified into the appropriate category.
Description

Pulmonary arterial hypertension, pulmonary venous hypertension or diastolic dysfunction or pulmonary hypertension secondary to interstitial lung disease

Data type

boolean

Alias
UMLS CUI [1]
C2973725
UMLS CUI [2,1]
C0340766
UMLS CUI [2,2]
C0034057
UMLS CUI [3]
C0520863
UMLS CUI [4]
C3698230
diagnosis of definite pulmonary hypertension patients with pulmonary hypertension with a right heart catheterization showing a mean pa pressure > 25mmhg, diagnosed in the past 6 months.
Description

pulmonary hypertension with a right heart catheterization showing a mean pa pressure > 25mmhg

Data type

boolean

Alias
UMLS CUI [1]
C0020542
UMLS CUI [2]
C2008312
classification of ph group 1 pah - patients with mpap ≥ 25mmhg with a wedge < 15mmhg group 2 pvh - patients who have a mean pa pressure ≥ 25mmhg with a wedge pressure which is > 15 mmhg group 3 ph-ild patients who have a mean pa pressure ≥ 25mmhg (on right heart catheterization) who have moderate to severe interstitial fibrosis on hrct scan with a fvc and tlc < 65% predicted
Description

mean pa pressure; wedge pressure; interstitial fibrosis; fvc and tlc

Data type

boolean

Alias
UMLS CUI [1]
C3854605
UMLS CUI [2]
C0034094
UMLS CUI [3]
C3887486
UMLS CUI [4]
C3714541
UMLS CUI [5]
C0040509
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
diagnosis and treatment of pulmonary hypertension for > 6 months
Description

pulmonary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0020542
patients with known severe interstitial fibrosis, pulmonary thrombotic disease, heart failure, cardiomyopathy,history of coronary artery disease or other cardio-pulmonary problems which could cause pulmonary hypertension are not eligible for the 'pre'-pulmonary hypertension but do qualify for the definite pulmonary hypertension group if they have a right heart catheterization showing a mean pah >25mmhg.
Description

interstitial fibrosis, pulmonary thrombotic disease, heart failure, cardiomyopathy,history of coronary artery disease or other cardio-pulmonary problems which could cause pulmonary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0240035
UMLS CUI [2]
C0151946
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0878544
UMLS CUI [5]
C1956346
UMLS CUI [6]
C1516295
UMLS CUI [7]
C2008312
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Similar models

Eligibility Systemic Sclerosis NCT00377949

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Inclusion Criteria
Item
eligible patients must meet all of the following inclusion criteria:
boolean
C1512693 (UMLS CUI [1])
Age; Systemic Scleroderma
Item
patient ≥ 18 years with a clinical diagnosis of ssc (acr criteria or the leroy criteria for limited or diffuse scleroderma
boolean
C0001779 (UMLS CUI [1])
C0036421 (UMLS CUI [2])
Inclusion Criteria
Item
2. specific inclusion criteria
boolean
C1512693 (UMLS CUI [1])
"pre" pulmonary arterial hypertension
Item
diagnosis of "pre" pulmonary arterial hypertension defined as:
boolean
C2973725 (UMLS CUI [1,1])
C1696708 (UMLS CUI [1,2])
sPAP
Item
echocardiogram with a resting spap of ≥ 40mmhg or
boolean
C0428643 (UMLS CUI [1])
ID.6
Item
pulmonary function test with fvc >70% and a dlco <55% of predicted or a fvc/dlco ratio >1.6. or
boolean
C3714541 (UMLS CUI [1])
C1516251 (UMLS CUI [2])
Mean pulmonary arterial pressure
Item
right heart catheterization which shows or a mean pa pressure > 30mmhg with exercise (with a mpap < 25mmhg at rest)
boolean
C2008312 (UMLS CUI [1])
Pulmonary arterial hypertension, pulmonary venous hypertension or diastolic dysfunction or pulmonary hypertension secondary to interstitial lung disease
Item
patients entered as a 'pre'-pulmonary arterial hypertension who then undergo right heart catheterization and are found to have pulmonary arterial hypertension, pulmonary venous hypertension or diastolic dysfunction or pulmonary hypertension secondary to interstitial lung disease will be followed as a definite ph patient and classified into the appropriate category.
boolean
C2973725 (UMLS CUI [1])
C0340766 (UMLS CUI [2,1])
C0034057 (UMLS CUI [2,2])
C0520863 (UMLS CUI [3])
C3698230 (UMLS CUI [4])
pulmonary hypertension with a right heart catheterization showing a mean pa pressure > 25mmhg
Item
diagnosis of definite pulmonary hypertension patients with pulmonary hypertension with a right heart catheterization showing a mean pa pressure > 25mmhg, diagnosed in the past 6 months.
boolean
C0020542 (UMLS CUI [1])
C2008312 (UMLS CUI [2])
mean pa pressure; wedge pressure; interstitial fibrosis; fvc and tlc
Item
classification of ph group 1 pah - patients with mpap ≥ 25mmhg with a wedge < 15mmhg group 2 pvh - patients who have a mean pa pressure ≥ 25mmhg with a wedge pressure which is > 15 mmhg group 3 ph-ild patients who have a mean pa pressure ≥ 25mmhg (on right heart catheterization) who have moderate to severe interstitial fibrosis on hrct scan with a fvc and tlc < 65% predicted
boolean
C3854605 (UMLS CUI [1])
C0034094 (UMLS CUI [2])
C3887486 (UMLS CUI [3])
C3714541 (UMLS CUI [4])
C0040509 (UMLS CUI [5])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
pulmonary hypertension
Item
diagnosis and treatment of pulmonary hypertension for > 6 months
boolean
C0020542 (UMLS CUI [1])
interstitial fibrosis, pulmonary thrombotic disease, heart failure, cardiomyopathy,history of coronary artery disease or other cardio-pulmonary problems which could cause pulmonary hypertension
Item
patients with known severe interstitial fibrosis, pulmonary thrombotic disease, heart failure, cardiomyopathy,history of coronary artery disease or other cardio-pulmonary problems which could cause pulmonary hypertension are not eligible for the 'pre'-pulmonary hypertension but do qualify for the definite pulmonary hypertension group if they have a right heart catheterization showing a mean pah >25mmhg.
boolean
C0240035 (UMLS CUI [1])
C0151946 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0878544 (UMLS CUI [4])
C1956346 (UMLS CUI [5])
C1516295 (UMLS CUI [6])
C2008312 (UMLS CUI [7])
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