ID

39455

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01452802

Nyckelord

Versioner (1)
  1. 2020-01-12 2020-01-12 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

12 januari 2020

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Heart Failure NCT01452802

Engelsk

Eligibility Heart Failure NCT01452802

1 Formulär  
Criteria
Beskrivning

Criteria

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

New York Heart Association Classification

Datatyp

boolean

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

Left ventricular ejection fraction

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Disease Management Optimal

Datatyp

boolean

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

Functional Status Limited | 6-Minute Walk Test Distance

Datatyp

boolean

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

ID.6

Datatyp

boolean

one hospitalization for hf in last 12 months or
Beskrivning

Hospitalization Due to Heart Failure Quantity Timespan

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Exclusion Criteria

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

Mechanical Aortic Valve | Mechanical Mitral Valve | Conversion Planned Bioprosthesis

Datatyp

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
Beskrivning

Platelet Count measurement

Datatyp

boolean

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

Inotropic agent

Datatyp

boolean

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

6-Minute Walk Test Unable

Datatyp

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
Beskrivning

Condition Limiting Survival | Exception Heart failure

Datatyp

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
Beskrivning

Heart Transplantation | Organ Transplantation

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Sepsis Uncontrolled

Datatyp

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
Beskrivning

Cerebrovascular accident Without Resolution | Cerebrovascular Disorders | Stenosis Extracranial Significant

Datatyp

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
Beskrivning

Medical contraindication Anticoagulation Therapy | Medical contraindication Antiplatelet therapy

Datatyp

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
Beskrivning

Cardiac Resynchronization Therapy | Cardiac Resynchronization Therapy Device

Datatyp

boolean

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

Coronary revascularisation | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Datatyp

boolean

Alias
UMLS CUI [1]
C0877341
UMLS CUI [2]
C0010055
UMLS CUI [3]
C1532338
Tillbaka till toppen

Similar models

Eligibility Heart Failure NCT01452802

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial