ID

35943

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02406820

Nyckelord

Versioner (1)
  1. 2019-04-05 2019-04-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 april 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02406820

Engelsk

Eligibility Heart Failure NCT02406820

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients ≥ 18 years old
Beskrivning

Adult | Age

Datatyp

boolean

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

Signs and Symptoms Congestive heart failure

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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.
Beskrivning

N-terminal prohormone brain natriuretic peptide increased

Datatyp

boolean

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

Protocol Compliance

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant patients
Beskrivning

Pregnancy

Datatyp

boolean

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

Left ventricular assist device | Heart Transplantation

Datatyp

boolean

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

Complex congenital heart disease | Heart Valve Prosthesis Right sided

Datatyp

boolean

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

Mitral Stenosis

Datatyp

boolean

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

Medical condition Unstable | Impairment | Exception Heart failure Related

Datatyp

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
Beskrivning

Hypertensive disease Unstable

Datatyp

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
Beskrivning

Study Subject Participation Status | Exclusion Due to Unstable status

Datatyp

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
Beskrivning

Infectious disease of lung | PULMONARY DECOMPENSATION

Datatyp

boolean

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

White blood cell count increased | Signs Communicable Disease

Datatyp

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
Beskrivning

Informed Consent Unable | Impaired cognition

Datatyp

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
Beskrivning

Hand grip Test Unable | Impaired cognition

Datatyp

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
Beskrivning

Hand grip Stress Test Unable

Datatyp

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
Beskrivning

Use of Device Unable

Datatyp

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
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Heart Failure NCT02406820

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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