ID

44291

Beskrivning

LVAD in Non Cardiac Transplant Candidates and Non Responders to Resynchronization; ODM derived from: https://clinicaltrials.gov/show/NCT01126944

Länk

https://clinicaltrials.gov/show/NCT01126944

Nyckelord

Versioner (2)
  1. 2020-01-05 2020-01-05 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure at NYHA Stage III or IV NCT01126944

Engelsk

Eligibility Heart Failure at NYHA Stage III or IV NCT01126944

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with heart failure class iii or iv nyha
Beskrivning

Heart failure New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
lvef < 35%
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
resynchronization for at least 6 months
Beskrivning

Cardiac Resynchronization

Datatyp

boolean

Alias
UMLS CUI [1]
C1167956
non eligibility for cardiac transplant
Beskrivning

Ineligibility Heart Transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C0018823
operability and psychological criteria assessed
Beskrivning

Assessment Patients Operable | Assessment Criteria Psychological

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0205188
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C0243161
UMLS CUI [2,3]
C0205486
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients incapable of understanding the proposed procedure, its risks and potential benefits or the consequences engendered by the permanent implanting of a left ventricular assist device
Beskrivning

Study Protocol Comprehension Unable | Implantation of left ventricular assist device Permanent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0397130
UMLS CUI [2,2]
C0205355
patients on mechanical circulatory support, including an intra-aortic counter-pulsion balloon, at the time of randomisation
Beskrivning

Mechanical Circulatory Support | Intra-aortic balloon counterpulsation

Datatyp

boolean

Alias
UMLS CUI [1]
C3274791
UMLS CUI [2]
C3826111
patients with acute decompensated cardiac insufficiency at the time of randomisation
Beskrivning

Decompensated cardiac failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0581377
patients whose body surface area is below 1.2m²
Beskrivning

Body Surface Area

Datatyp

boolean

Alias
UMLS CUI [1]
C0005902
patients with a mechanical cardiac valve
Beskrivning

Mechanical cardiac valve

Datatyp

boolean

Alias
UMLS CUI [1]
C3873910
patients requiring associated aortic or mitral surgery
Beskrivning

Aortic surgery Required | Mitral valve operation Required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877130
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C0519382
UMLS CUI [2,2]
C1514873
patients with an active uncontrolled infection
Beskrivning

Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
patients with a severe pulmonary respiratory pathology
Beskrivning

Respiration Disorder Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035204
UMLS CUI [1,2]
C0205082
patients with contra-indications for or an intolerance to anti-coagulants or platelet anti-aggregants
Beskrivning

Medical contraindication Anticoagulants | intolerance to Anticoagulants | Medical contraindication Platelet Aggregation Inhibitors | intolerance to Platelet Aggregation Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003280
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0003280
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0032177
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0032177
presence of risk factors or indicators of visceral failure (severe copd, renal insufficiency with dialysis, hepatic insufficiency with cholestasis…)
Beskrivning

Risk factors Failure Visceral | Indicators Failure Visceral | Severe chronic obstructive pulmonary disease | Renal Insufficiency with Dialysis | Hepatic Insufficiency with Cholestasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0231174
UMLS CUI [1,3]
C0442045
UMLS CUI [2,1]
C0021212
UMLS CUI [2,2]
C0231174
UMLS CUI [2,3]
C0442045
UMLS CUI [3]
C0730607
UMLS CUI [4,1]
C1565489
UMLS CUI [4,2]
C0332287
UMLS CUI [4,3]
C0011946
UMLS CUI [5,1]
C1306571
UMLS CUI [5,2]
C0332287
UMLS CUI [5,3]
C0008370
patients with a lietz/miller operating mortality score ≥ "high risk"
Beskrivning

Mortality Operative Score High risk

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026565
UMLS CUI [1,2]
C1882154
UMLS CUI [1,3]
C0449820
UMLS CUI [1,4]
C4319571
patients with an elevated risk of an embolism and atrial intra-cardiac thrombus
Beskrivning

High risk of Embolism | High risk of Atrial thrombus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0013922
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0340517
severe right ventricular failure (echography and right cardiac catheter examination) with the probable need for right ventricular mechanical assistance
Beskrivning

Right ventricular failure Severe Ultrasonography | Right ventricular failure Severe Catheterization of right heart | Patient need for Mechanical assistance Right ventricle

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0235527
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0041618
UMLS CUI [2,1]
C0235527
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0189896
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0456150
UMLS CUI [3,3]
C0225883
patients who are candidates for coronary revascularisation
Beskrivning

Patients Appropriate Coronary revascularisation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0877341
participation in another study which may interact with the proposed clinical trial.
Beskrivning

Study Subject Participation Status | Interference Clinical Trials

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0008976
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Similar models

Eligibility Heart Failure at NYHA Stage III or IV NCT01126944

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure New York Heart Association Classification
Item
patients with heart failure class iii or iv nyha
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
lvef < 35%
boolean
C0428772 (UMLS CUI [1])
Cardiac Resynchronization
Item
resynchronization for at least 6 months
boolean
C1167956 (UMLS CUI [1])
Ineligibility Heart Transplantation
Item
non eligibility for cardiac transplant
boolean
C1512714 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
Assessment Patients Operable | Assessment Criteria Psychological
Item
operability and psychological criteria assessed
boolean
C1516048 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0205188 (UMLS CUI [1,3])
C1516048 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C0205486 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Study Protocol Comprehension Unable | Implantation of left ventricular assist device Permanent
Item
patients incapable of understanding the proposed procedure, its risks and potential benefits or the consequences engendered by the permanent implanting of a left ventricular assist device
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0397130 (UMLS CUI [2,1])
C0205355 (UMLS CUI [2,2])
Mechanical Circulatory Support | Intra-aortic balloon counterpulsation
Item
patients on mechanical circulatory support, including an intra-aortic counter-pulsion balloon, at the time of randomisation
boolean
C3274791 (UMLS CUI [1])
C3826111 (UMLS CUI [2])
Decompensated cardiac failure
Item
patients with acute decompensated cardiac insufficiency at the time of randomisation
boolean
C0581377 (UMLS CUI [1])
Body Surface Area
Item
patients whose body surface area is below 1.2m²
boolean
C0005902 (UMLS CUI [1])
Mechanical cardiac valve
Item
patients with a mechanical cardiac valve
boolean
C3873910 (UMLS CUI [1])
Aortic surgery Required | Mitral valve operation Required
Item
patients requiring associated aortic or mitral surgery
boolean
C0877130 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0519382 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Communicable Disease Uncontrolled
Item
patients with an active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Respiration Disorder Severe
Item
patients with a severe pulmonary respiratory pathology
boolean
C0035204 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Medical contraindication Anticoagulants | intolerance to Anticoagulants | Medical contraindication Platelet Aggregation Inhibitors | intolerance to Platelet Aggregation Inhibitors
Item
patients with contra-indications for or an intolerance to anti-coagulants or platelet anti-aggregants
boolean
C1301624 (UMLS CUI [1,1])
C0003280 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0003280 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0032177 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0032177 (UMLS CUI [4,2])
Risk factors Failure Visceral | Indicators Failure Visceral | Severe chronic obstructive pulmonary disease | Renal Insufficiency with Dialysis | Hepatic Insufficiency with Cholestasis
Item
presence of risk factors or indicators of visceral failure (severe copd, renal insufficiency with dialysis, hepatic insufficiency with cholestasis…)
boolean
C0035648 (UMLS CUI [1,1])
C0231174 (UMLS CUI [1,2])
C0442045 (UMLS CUI [1,3])
C0021212 (UMLS CUI [2,1])
C0231174 (UMLS CUI [2,2])
C0442045 (UMLS CUI [2,3])
C0730607 (UMLS CUI [3])
C1565489 (UMLS CUI [4,1])
C0332287 (UMLS CUI [4,2])
C0011946 (UMLS CUI [4,3])
C1306571 (UMLS CUI [5,1])
C0332287 (UMLS CUI [5,2])
C0008370 (UMLS CUI [5,3])
Mortality Operative Score High risk
Item
patients with a lietz/miller operating mortality score ≥ "high risk"
boolean
C0026565 (UMLS CUI [1,1])
C1882154 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C4319571 (UMLS CUI [1,4])
High risk of Embolism | High risk of Atrial thrombus
Item
patients with an elevated risk of an embolism and atrial intra-cardiac thrombus
boolean
C0332167 (UMLS CUI [1,1])
C0013922 (UMLS CUI [1,2])
C0332167 (UMLS CUI [2,1])
C0340517 (UMLS CUI [2,2])
Right ventricular failure Severe Ultrasonography | Right ventricular failure Severe Catheterization of right heart | Patient need for Mechanical assistance Right ventricle
Item
severe right ventricular failure (echography and right cardiac catheter examination) with the probable need for right ventricular mechanical assistance
boolean
C0235527 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
C0235527 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0189896 (UMLS CUI [2,3])
C0686904 (UMLS CUI [3,1])
C0456150 (UMLS CUI [3,2])
C0225883 (UMLS CUI [3,3])
Patients Appropriate Coronary revascularisation
Item
patients who are candidates for coronary revascularisation
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0877341 (UMLS CUI [1,3])
Study Subject Participation Status | Interference Clinical Trials
Item
participation in another study which may interact with the proposed clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0521102 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
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