ID

35943

Descrição

Correlating Noninvasive Cardiovascular Measures to Left Ventricular End Diastolic Pressure in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02406820

Link

https://clinicaltrials.gov/show/NCT02406820

Palavras-chave

Versões (1)
  1. 05/04/2019 05/04/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

5 de abril de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02406820

Inglês

Eligibility Heart Failure NCT02406820

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients ≥ 18 years old
Descrição

Adult | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
signs and symptoms of congestive heart failure including two of the following:
Descrição

Signs and Symptoms Congestive heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0018802
peripheral edema (e.g. abdominal distension, hepatomegaly, lower extremity edema) in the setting of elevated jugular venous pressure as assessed by the clinical examination, or by right heart catheterization.
Descrição

Peripheral edema | Abdomen distended | Hepatomegaly | Edema of lower extremity | Raised jugular venous pressure | Clinical examination | Catheterization of right heart

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085649
UMLS CUI [2]
C0000731
UMLS CUI [3]
C0019209
UMLS CUI [4]
C0239340
UMLS CUI [5]
C0520861
UMLS CUI [6]
C1456356
UMLS CUI [7]
C0189896
pulmonary edema or pleural effusion as seen on chest x-ray
Descrição

Pulmonary Edema Plain chest X-ray | Pleural effusion Plain chest X-ray

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0034063
UMLS CUI [1,2]
C0039985
UMLS CUI [2,1]
C0032227
UMLS CUI [2,2]
C0039985
elevated n-terminal pro-brain natriuretic peptide (nt-pro bnp) 2x the upper limit of normal.
Descrição

N-terminal prohormone brain natriuretic peptide increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3203708
willing and able to comply with the study protocol
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
willing and able to give valid informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant patients
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
presence of left ventricular assist device (lvad) or heart transplant
Descrição

Left ventricular assist device | Heart Transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0181598
UMLS CUI [2]
C0018823
complex congenital heart disorder or prosthetic valve on right side
Descrição

Complex congenital heart disease | Heart Valve Prosthesis Right sided

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0744669
UMLS CUI [2,1]
C0018825
UMLS CUI [2,2]
C0444532
known mitral stenosis
Descrição

Mitral Stenosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026269
unstable medical condition or impairment other than condition associated with hf
Descrição

Medical condition Unstable | Impairment | Exception Heart failure Related

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0221099
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0018801
UMLS CUI [3,3]
C0439849
unstable hypertension
Descrição

Hypertensive disease Unstable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0443343
too unstable in the judgment of the investigator to be included in the study
Descrição

Study Subject Participation Status | Exclusion Due to Unstable status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0443343
active lung infection or acute pulmonary decompensation
Descrição

Infectious disease of lung | PULMONARY DECOMPENSATION

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0876973
UMLS CUI [2]
C0748117
elevated white blood cell count and signs of infection are evident
Descrição

White blood cell count increased | Signs Communicable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0750426
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0009450
does not have the cognitive ability to understand and sign the informed consent
Descrição

Informed Consent Unable | Impaired cognition

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2]
C0338656
does not have the cognitive capacity to perform handgrip test
Descrição

Hand grip Test Unable | Impaired cognition

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1293900
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0338656
is not able to perform a handgrip stress test
Descrição

Hand grip Stress Test Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1293900
UMLS CUI [1,2]
C3494508
UMLS CUI [1,3]
C1299582
is not able to wear any of the devices
Descrição

Use of Device Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0699733
UMLS CUI [1,3]
C1299582
patient's life expectancy is less than 3 months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Heart Failure NCT02406820

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients ≥ 18 years old
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Signs and Symptoms Congestive heart failure
Item
signs and symptoms of congestive heart failure including two of the following:
boolean
C0037088 (UMLS CUI [1,1])
C0018802 (UMLS CUI [1,2])
Peripheral edema | Abdomen distended | Hepatomegaly | Edema of lower extremity | Raised jugular venous pressure | Clinical examination | Catheterization of right heart
Item
peripheral edema (e.g. abdominal distension, hepatomegaly, lower extremity edema) in the setting of elevated jugular venous pressure as assessed by the clinical examination, or by right heart catheterization.
boolean
C0085649 (UMLS CUI [1])
C0000731 (UMLS CUI [2])
C0019209 (UMLS CUI [3])
C0239340 (UMLS CUI [4])
C0520861 (UMLS CUI [5])
C1456356 (UMLS CUI [6])
C0189896 (UMLS CUI [7])
Pulmonary Edema Plain chest X-ray | Pleural effusion Plain chest X-ray
Item
pulmonary edema or pleural effusion as seen on chest x-ray
boolean
C0034063 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2,1])
C0039985 (UMLS CUI [2,2])
N-terminal prohormone brain natriuretic peptide increased
Item
elevated n-terminal pro-brain natriuretic peptide (nt-pro bnp) 2x the upper limit of normal.
boolean
C3203708 (UMLS CUI [1])
Protocol Compliance
Item
willing and able to comply with the study protocol
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
willing and able to give valid informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
pregnant patients
boolean
C0032961 (UMLS CUI [1])
Left ventricular assist device | Heart Transplantation
Item
presence of left ventricular assist device (lvad) or heart transplant
boolean
C0181598 (UMLS CUI [1])
C0018823 (UMLS CUI [2])
Complex congenital heart disease | Heart Valve Prosthesis Right sided
Item
complex congenital heart disorder or prosthetic valve on right side
boolean
C0744669 (UMLS CUI [1])
C0018825 (UMLS CUI [2,1])
C0444532 (UMLS CUI [2,2])
Mitral Stenosis
Item
known mitral stenosis
boolean
C0026269 (UMLS CUI [1])
Medical condition Unstable | Impairment | Exception Heart failure Related
Item
unstable medical condition or impairment other than condition associated with hf
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0221099 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0018801 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
Hypertensive disease Unstable
Item
unstable hypertension
boolean
C0020538 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Study Subject Participation Status | Exclusion Due to Unstable status
Item
too unstable in the judgment of the investigator to be included in the study
boolean
C2348568 (UMLS CUI [1])
C2828389 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
Infectious disease of lung | PULMONARY DECOMPENSATION
Item
active lung infection or acute pulmonary decompensation
boolean
C0876973 (UMLS CUI [1])
C0748117 (UMLS CUI [2])
White blood cell count increased | Signs Communicable Disease
Item
elevated white blood cell count and signs of infection are evident
boolean
C0750426 (UMLS CUI [1])
C0311392 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
Informed Consent Unable | Impaired cognition
Item
does not have the cognitive ability to understand and sign the informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0338656 (UMLS CUI [2])
Hand grip Test Unable | Impaired cognition
Item
does not have the cognitive capacity to perform handgrip test
boolean
C1293900 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0338656 (UMLS CUI [2])
Hand grip Stress Test Unable
Item
is not able to perform a handgrip stress test
boolean
C1293900 (UMLS CUI [1,1])
C3494508 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Use of Device Unable
Item
is not able to wear any of the devices
boolean
C1524063 (UMLS CUI [1,1])
C0699733 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Life Expectancy
Item
patient's life expectancy is less than 3 months
boolean
C0023671 (UMLS CUI [1])
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