ID

15186

Descrizione

CardioMEMS HF System Post Approval Study; ODM derived from: https://clinicaltrials.gov/show/NCT02279888

collegamento

https://clinicaltrials.gov/show/NCT02279888

Keywords

  1. 21/05/16 21/05/16 -
Caricato su

21 maggio 2016

DOI

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Licenza

Creative Commons BY 4.0

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Eligibility Heart Failure NCT02279888

Eligibility Heart Failure NCT02279888

Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of nyha class iii heart failure
Descrizione

New York Heart Association Classification

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1275491
at least 1 heart failure hospitalization within previous 12 months
Descrizione

Hospitalization Due to Heart Failure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3898876
patients with reduced lvef heart failure should be receiving a beta blocker for 3 months and an ace-i or arb for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ace-i or arb
Descrizione

Heart failure | Left ventricular ejection fraction Reduced | Adrenergic beta-Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Intolerance Adrenergic beta-Antagonists | Intolerance Angiotensin-Converting Enzyme Inhibitors | Intolerance Angiotensin II receptor antagonist

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0428772
UMLS CUI [1,3]
C0392756
UMLS CUI [2]
C0001645
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0521942
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0001645
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0003015
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0521942
bmi ≤ 35. patients with bmi >35 will require their chest circumference to be measured at the axillary level. if > 65 inches the patient will not be eligible for the study.
Descrizione

Body mass index | Measurement of chest circumference Axilla

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2,1]
C4039710
UMLS CUI [2,2]
C0004454
pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)
Descrizione

Pulmonary artery branch Diameter | Implant Target Artery | Catheterization of right heart

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1282007
UMLS CUI [1,2]
C1301886
UMLS CUI [2,1]
C0021102
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0003842
UMLS CUI [3]
C0189896
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection
Descrizione

Communicable Diseases

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009450
history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
Descrizione

Recurrent pulmonary embolism | Deep Vein Thrombosis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1735914
UMLS CUI [2]
C0149871
inability to tolerate a right heart catheterization
Descrizione

Catheterization of right heart Unable

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0189896
UMLS CUI [1,2]
C1299582
a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
Descrizione

Cardiovascular event Major | Thallium stress test | Open heart surgery | Cerebrovascular accident

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C1455714
UMLS CUI [3]
C0189745
UMLS CUI [4]
C0038454
cardiac resynchronization device (crt) implanted within previous 3 months
Descrizione

Implantation procedure Cardiac Resynchronization Therapy Devices

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0021107
UMLS CUI [1,2]
C2936377
glomerular filtration rate (gfr) < 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
Descrizione

Glomerular Filtration Rate | Implantation procedure | Responsive to Diuretic therapy | H/O: renal dialysis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0017654
UMLS CUI [2]
C0021107
UMLS CUI [3,1]
C1833335
UMLS CUI [3,2]
C0948575
UMLS CUI [4]
C0455667
congenital heart disease or mechanical right heart valve
Descrizione

Congenital heart disease | MECHANICAL HEART-VALVE Right

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0152021
UMLS CUI [2,1]
C0493527
UMLS CUI [2,2]
C0205090
likely to undergo heart transplantation or vad within the next 6 months
Descrizione

Heart Transplantation | Artificial Ventricle

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2]
C0085842
known coagulation disorders
Descrizione

Blood Coagulation Disorders

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005779
hypersensitivity or allergy to aspirin, and/or clopidogrel
Descrizione

Hypersensitivity Aspirin | Hypersensitivity clopidogrel

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0070166

Similar models

Eligibility Heart Failure NCT02279888

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
New York Heart Association Classification
Item
diagnosis of nyha class iii heart failure
boolean
C1275491 (UMLS CUI [1])
Hospitalization Due to Heart Failure
Item
at least 1 heart failure hospitalization within previous 12 months
boolean
C3898876 (UMLS CUI [1])
Heart failure | Left ventricular ejection fraction Reduced | Adrenergic beta-Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Intolerance Adrenergic beta-Antagonists | Intolerance Angiotensin-Converting Enzyme Inhibitors | Intolerance Angiotensin II receptor antagonist
Item
patients with reduced lvef heart failure should be receiving a beta blocker for 3 months and an ace-i or arb for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ace-i or arb
boolean
C0018801 (UMLS CUI [1,1])
C0428772 (UMLS CUI [1,2])
C0392756 (UMLS CUI [1,3])
C0001645 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
C1744706 (UMLS CUI [5,1])
C0001645 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0003015 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0521942 (UMLS CUI [7,2])
Body mass index | Measurement of chest circumference Axilla
Item
bmi ≤ 35. patients with bmi >35 will require their chest circumference to be measured at the axillary level. if > 65 inches the patient will not be eligible for the study.
boolean
C1305855 (UMLS CUI [1])
C4039710 (UMLS CUI [2,1])
C0004454 (UMLS CUI [2,2])
Pulmonary artery branch Diameter | Implant Target Artery | Catheterization of right heart
Item
pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)
boolean
C1282007 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0021102 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0003842 (UMLS CUI [2,3])
C0189896 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Communicable Diseases
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Recurrent pulmonary embolism | Deep Vein Thrombosis
Item
history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
boolean
C1735914 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
Catheterization of right heart Unable
Item
inability to tolerate a right heart catheterization
boolean
C0189896 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Cardiovascular event Major | Thallium stress test | Open heart surgery | Cerebrovascular accident
Item
a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1455714 (UMLS CUI [2])
C0189745 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
Implantation procedure Cardiac Resynchronization Therapy Devices
Item
cardiac resynchronization device (crt) implanted within previous 3 months
boolean
C0021107 (UMLS CUI [1,1])
C2936377 (UMLS CUI [1,2])
Glomerular Filtration Rate | Implantation procedure | Responsive to Diuretic therapy | H/O: renal dialysis
Item
glomerular filtration rate (gfr) < 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
boolean
C0017654 (UMLS CUI [1])
C0021107 (UMLS CUI [2])
C1833335 (UMLS CUI [3,1])
C0948575 (UMLS CUI [3,2])
C0455667 (UMLS CUI [4])
Congenital heart disease | MECHANICAL HEART-VALVE Right
Item
congenital heart disease or mechanical right heart valve
boolean
C0152021 (UMLS CUI [1])
C0493527 (UMLS CUI [2,1])
C0205090 (UMLS CUI [2,2])
Heart Transplantation | Artificial Ventricle
Item
likely to undergo heart transplantation or vad within the next 6 months
boolean
C0018823 (UMLS CUI [1])
C0085842 (UMLS CUI [2])
Blood Coagulation Disorders
Item
known coagulation disorders
boolean
C0005779 (UMLS CUI [1])
Hypersensitivity Aspirin | Hypersensitivity clopidogrel
Item
hypersensitivity or allergy to aspirin, and/or clopidogrel
boolean
C0020517 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])

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