ID

39455

Descrição

Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management; ODM derived from: https://clinicaltrials.gov/show/NCT01452802

Link

https://clinicaltrials.gov/show/NCT01452802

Palavras-chave

Versões (1)
  1. 12/01/2020 12/01/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

12 de janeiro de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01452802

Inglês

Eligibility Heart Failure NCT01452802

1 Formulários  
Criteria
Descrição

Criteria

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
nyha class iiib/iv (refer to appendix iv for definitions)
Descrição

New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1275491
left ventricular ejection fraction (lvef) ≤ 25%
Descrição

Left ventricular ejection fraction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428772
not currently listed for heart transplantation, and not planned in next 12 months
Descrição

Absence Patient on waiting list Heart Transplantation | Absence Heart Transplantation Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0422768
UMLS CUI [1,3]
C0018823
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0018823
UMLS CUI [2,3]
C1301732
on optimal medical management
Descrição

Disease Management Optimal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0376636
UMLS CUI [1,2]
C2698651
limited functional status as demonstrated by 6mwt <300 meters
Descrição

Functional Status Limited | 6-Minute Walk Test Distance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0598463
UMLS CUI [1,2]
C0439801
UMLS CUI [2,1]
C0430515
UMLS CUI [2,2]
C0012751
at least:
Descrição

ID.6

Tipo de dados

boolean

one hospitalization for hf in last 12 months or
Descrição

Hospitalization Due to Heart Failure Quantity Timespan

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3898876
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
at least 2 unscheduled emergency room or infusion clinic visits (may include intravenous diuretic therapy, etc.) for hf in last 12 months
Descrição

Emergency department patient visit Unscheduled Quantity Heart failure | Infusion Clinic Visits Quantity Heart failure | Diuretic therapy Intravenous Heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0586082
UMLS CUI [1,2]
C3854240
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0018801
UMLS CUI [2,1]
C0574032
UMLS CUI [2,2]
C0008952
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0018801
UMLS CUI [3,1]
C0948575
UMLS CUI [3,2]
C1522726
UMLS CUI [3,3]
C0018801
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of mechanical aortic or mitral valve, including planned conversion to bioprosthesis
Descrição

Mechanical Aortic Valve | Mechanical Mitral Valve | Conversion Planned Bioprosthesis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2825203
UMLS CUI [2]
C2825205
UMLS CUI [3,1]
C0439836
UMLS CUI [3,2]
C1301732
UMLS CUI [3,3]
C0005557
platelet count < 100,000/mi within 48 prior to enrollment
Descrição

Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
any inotrope use within 30 days prior to enrollment
Descrição

Inotropic agent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0304509
inability to perform 6mwt for any reason
Descrição

6-Minute Walk Test Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C1299582
any condition, other than heart failure, that could limit survival to less than 2 years
Descrição

Condition Limiting Survival | Exception Heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0038952
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018801
history of cardiac or other organ transplant
Descrição

Heart Transplantation | Organ Transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2]
C0029216
existence of any ongoing mechanical circulatory support (including intraaortic balloon pump, temporary circulatory support devices, etc.) at the time of enrollment
Descrição

Mechanical Circulatory Support | Intra-Aortic Balloon Pump | Support device circulatory temporary

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3274791
UMLS CUI [2]
C0021860
UMLS CUI [3,1]
C0183683
UMLS CUI [3,2]
C0005775
UMLS CUI [3,3]
C0205374
presence of active, uncontrolled, systemic infection
Descrição

Sepsis Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0205318
history of an unresolved stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (> 80%)extracranial stenosis
Descrição

Cerebrovascular accident Without Resolution | Cerebrovascular Disorders | Stenosis Extracranial Significant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C1514893
UMLS CUI [2]
C0007820
UMLS CUI [3,1]
C1261287
UMLS CUI [3,2]
C0580586
UMLS CUI [3,3]
C0750502
contraindication to anticoagulation/antiplatelet therapy
Descrição

Medical contraindication Anticoagulation Therapy | Medical contraindication Antiplatelet therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003281
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1096021
crt or crt-d within 3 months prior to enrollment
Descrição

Cardiac Resynchronization Therapy | Cardiac Resynchronization Therapy Device

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1167956
UMLS CUI [2]
C2936377
coronary revascularization (e.g. cabg, pci) within 3 months prior to enrollment
Descrição

Coronary revascularisation | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0877341
UMLS CUI [2]
C0010055
UMLS CUI [3]
C1532338
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Similar models

Eligibility Heart Failure NCT01452802

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
New York Heart Association Classification
Item
nyha class iiib/iv (refer to appendix iv for definitions)
boolean
C1275491 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) ≤ 25%
boolean
C0428772 (UMLS CUI [1])
Absence Patient on waiting list Heart Transplantation | Absence Heart Transplantation Planned
Item
not currently listed for heart transplantation, and not planned in next 12 months
boolean
C0332197 (UMLS CUI [1,1])
C0422768 (UMLS CUI [1,2])
C0018823 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0018823 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Disease Management Optimal
Item
on optimal medical management
boolean
C0376636 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
Functional Status Limited | 6-Minute Walk Test Distance
Item
limited functional status as demonstrated by 6mwt <300 meters
boolean
C0598463 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0430515 (UMLS CUI [2,1])
C0012751 (UMLS CUI [2,2])
ID.6
Item
at least:
boolean
Hospitalization Due to Heart Failure Quantity Timespan
Item
one hospitalization for hf in last 12 months or
boolean
C3898876 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Emergency department patient visit Unscheduled Quantity Heart failure | Infusion Clinic Visits Quantity Heart failure | Diuretic therapy Intravenous Heart failure
Item
at least 2 unscheduled emergency room or infusion clinic visits (may include intravenous diuretic therapy, etc.) for hf in last 12 months
boolean
C0586082 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0018801 (UMLS CUI [1,4])
C0574032 (UMLS CUI [2,1])
C0008952 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0018801 (UMLS CUI [2,4])
C0948575 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0018801 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Mechanical Aortic Valve | Mechanical Mitral Valve | Conversion Planned Bioprosthesis
Item
presence of mechanical aortic or mitral valve, including planned conversion to bioprosthesis
boolean
C2825203 (UMLS CUI [1])
C2825205 (UMLS CUI [2])
C0439836 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0005557 (UMLS CUI [3,3])
Platelet Count measurement
Item
platelet count < 100,000/mi within 48 prior to enrollment
boolean
C0032181 (UMLS CUI [1])
Inotropic agent
Item
any inotrope use within 30 days prior to enrollment
boolean
C0304509 (UMLS CUI [1])
6-Minute Walk Test Unable
Item
inability to perform 6mwt for any reason
boolean
C0430515 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Condition Limiting Survival | Exception Heart failure
Item
any condition, other than heart failure, that could limit survival to less than 2 years
boolean
C0348080 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0038952 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
Heart Transplantation | Organ Transplantation
Item
history of cardiac or other organ transplant
boolean
C0018823 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
Mechanical Circulatory Support | Intra-Aortic Balloon Pump | Support device circulatory temporary
Item
existence of any ongoing mechanical circulatory support (including intraaortic balloon pump, temporary circulatory support devices, etc.) at the time of enrollment
boolean
C3274791 (UMLS CUI [1])
C0021860 (UMLS CUI [2])
C0183683 (UMLS CUI [3,1])
C0005775 (UMLS CUI [3,2])
C0205374 (UMLS CUI [3,3])
Sepsis Uncontrolled
Item
presence of active, uncontrolled, systemic infection
boolean
C0243026 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Cerebrovascular accident Without Resolution | Cerebrovascular Disorders | Stenosis Extracranial Significant
Item
history of an unresolved stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (> 80%)extracranial stenosis
boolean
C0038454 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C1514893 (UMLS CUI [1,3])
C0007820 (UMLS CUI [2])
C1261287 (UMLS CUI [3,1])
C0580586 (UMLS CUI [3,2])
C0750502 (UMLS CUI [3,3])
Medical contraindication Anticoagulation Therapy | Medical contraindication Antiplatelet therapy
Item
contraindication to anticoagulation/antiplatelet therapy
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1096021 (UMLS CUI [2,2])
Cardiac Resynchronization Therapy | Cardiac Resynchronization Therapy Device
Item
crt or crt-d within 3 months prior to enrollment
boolean
C1167956 (UMLS CUI [1])
C2936377 (UMLS CUI [2])
Coronary revascularisation | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
coronary revascularization (e.g. cabg, pci) within 3 months prior to enrollment
boolean
C0877341 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
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