ID

22439

Descripción

Wireless, Intermittent Monitoring of Right Heart Pressures in HF; ODM derived from: https://clinicaltrials.gov/show/NCT01162707

Link

https://clinicaltrials.gov/show/NCT01162707

Palabras clave

Versiones (1)
  1. 4/6/17 4/6/17 -
Subido en

4 de junio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility NYHA Class III Heart Failure NCT01162707

Inglés

Eligibility NYHA Class III Heart Failure NCT01162707

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject is male or female, at least 18 years of age
Descripción

gender, age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. subjects of childbearing age who have a negative serum pregnancy test, and at screening have agreed to use a reliable mechanical or hormonal form of conception during the study.
Descripción

childbearing age, pregnancy test, contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1960468
UMLS CUI [1,2]
C0032976
UMLS CUI [1,3]
C0700589
3. subject has a diagnosis of new york heart association (nyha) class iii hf at screening and at baseline.
Descripción

congestive heart failure, nyha class

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
4. subject is able and willing to provide written informed consent or the subject guardian is able and willing to provide informed consent.
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
5. subject has life expectancy of 1-2 years.
Descripción

life expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject has unstable medical condition or impairment other than a medical condition associated with hf which would significantly increase the subject's morbidity or mortality risk.
Descripción

unstable medical condition, morbidity, mortality

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0220880
UMLS CUI [1,4]
C0681679
2. subject is unable to tolerate a right heart catheterization.
Descripción

right heart catheterization, toleration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0189896
UMLS CUI [1,2]
C0680282
3. subject is planned to undergo a heart transplantation or cardiac surgery within 2 months after enrollment.
Descripción

planned heart transplantation or cardiac surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C0018823
UMLS CUI [2,1]
C1301732
UMLS CUI [2,2]
C0018821
4. subject has permanent indwelling central venous catheter.
Descripción

permanent indwelling central venous catheter

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205355
UMLS CUI [1,2]
C2049627
5. subject has history of myocardial infarction (mi), unstable angina, stroke, transient ischemic attack, or intractable arrhythmias within last 2 months.
Descripción

medical history myocardial infarction, unstable angina, stroke, transient ischemic attack, or intractable arrhythmia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0007787
UMLS CUI [6,1]
C0003811
UMLS CUI [6,2]
C0205269
6. subject has history of congenital heart disease or prosthetic valve on right side.
Descripción

congenital heart disease, prosthetic valve on right side

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0152021
UMLS CUI [2,1]
C0336548
UMLS CUI [2,2]
C0225808
7. subject has unstable hypertension.
Descripción

unstable hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0443343
UMLS CUI [1,2]
C0020538
8. subject has a known coagulability disease state.
Descripción

coagulability disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005779
9. subject has a known hypersensitivity and/or allergy to aspirin and clopidogrel.
Descripción

hypersensitivity clopidogrel, aspirin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0070166
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0004057
10. subject has active lung infection or acute pulmonary decompensation.
Descripción

lung infection, pulmonary decompensation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0876973
UMLS CUI [2]
C0748117
11. subject has elevated white blood cell count and signs of infection are evident.
Descripción

elevated white blood cell count and signs of infection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0750426
UMLS CUI [1,2]
C0513965
12. subject has chronic renal insufficiency as defined by serum creatinine of greater than or equal to 2 mg/dl or requirement for dialysis.
Descripción

chronic renal insufficiency, serum creatinine, dialysis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0403447
UMLS CUI [1,2]
C0201976
UMLS CUI [1,3]
C0011946
13. subject who is pregnant or lactating or might become pregnant during the duration of the study.
Descripción

pregnancy, breast feeding, childbearing potential

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
14. subject who is participating in another therapeutic interventional trial.
Descripción

study subject participation status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
15. subject has other medical, psychological, or social circumstances that may affect the ability to comply with the study requirements or increase risk to the subject.
Descripción

compliance behavior, comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0009488
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Similar models

Eligibility NYHA Class III Heart Failure NCT01162707

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
gender, age
Item
1. subject is male or female, at least 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
childbearing age, pregnancy test, contraceptive methods
Item
2. subjects of childbearing age who have a negative serum pregnancy test, and at screening have agreed to use a reliable mechanical or hormonal form of conception during the study.
boolean
C1960468 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
congestive heart failure, nyha class
Item
3. subject has a diagnosis of new york heart association (nyha) class iii hf at screening and at baseline.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
informed consent
Item
4. subject is able and willing to provide written informed consent or the subject guardian is able and willing to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
life expectancy
Item
5. subject has life expectancy of 1-2 years.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
unstable medical condition, morbidity, mortality
Item
1. subject has unstable medical condition or impairment other than a medical condition associated with hf which would significantly increase the subject's morbidity or mortality risk.
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0220880 (UMLS CUI [1,3])
C0681679 (UMLS CUI [1,4])
right heart catheterization, toleration
Item
2. subject is unable to tolerate a right heart catheterization.
boolean
C0189896 (UMLS CUI [1,1])
C0680282 (UMLS CUI [1,2])
planned heart transplantation or cardiac surgery
Item
3. subject is planned to undergo a heart transplantation or cardiac surgery within 2 months after enrollment.
boolean
C1301732 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
C1301732 (UMLS CUI [2,1])
C0018821 (UMLS CUI [2,2])
permanent indwelling central venous catheter
Item
4. subject has permanent indwelling central venous catheter.
boolean
C0205355 (UMLS CUI [1,1])
C2049627 (UMLS CUI [1,2])
medical history myocardial infarction, unstable angina, stroke, transient ischemic attack, or intractable arrhythmia
Item
5. subject has history of myocardial infarction (mi), unstable angina, stroke, transient ischemic attack, or intractable arrhythmias within last 2 months.
boolean
C0262926 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
C0003811 (UMLS CUI [6,1])
C0205269 (UMLS CUI [6,2])
congenital heart disease, prosthetic valve on right side
Item
6. subject has history of congenital heart disease or prosthetic valve on right side.
boolean
C0152021 (UMLS CUI [1])
C0336548 (UMLS CUI [2,1])
C0225808 (UMLS CUI [2,2])
unstable hypertension
Item
7. subject has unstable hypertension.
boolean
C0443343 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
coagulability disease
Item
8. subject has a known coagulability disease state.
boolean
C0005779 (UMLS CUI [1])
hypersensitivity clopidogrel, aspirin
Item
9. subject has a known hypersensitivity and/or allergy to aspirin and clopidogrel.
boolean
C0020517 (UMLS CUI [1,1])
C0070166 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
lung infection, pulmonary decompensation
Item
10. subject has active lung infection or acute pulmonary decompensation.
boolean
C0876973 (UMLS CUI [1])
C0748117 (UMLS CUI [2])
elevated white blood cell count and signs of infection
Item
11. subject has elevated white blood cell count and signs of infection are evident.
boolean
C0750426 (UMLS CUI [1,1])
C0513965 (UMLS CUI [1,2])
chronic renal insufficiency, serum creatinine, dialysis
Item
12. subject has chronic renal insufficiency as defined by serum creatinine of greater than or equal to 2 mg/dl or requirement for dialysis.
boolean
C0403447 (UMLS CUI [1,1])
C0201976 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
pregnancy, breast feeding, childbearing potential
Item
13. subject who is pregnant or lactating or might become pregnant during the duration of the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
study subject participation status
Item
14. subject who is participating in another therapeutic interventional trial.
boolean
C2348568 (UMLS CUI [1])
compliance behavior, comorbidity
Item
15. subject has other medical, psychological, or social circumstances that may affect the ability to comply with the study requirements or increase risk to the subject.
boolean
C1321605 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
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