ID

39487

Descrição

C-Pulse® System European Multicenter Study; ODM derived from: https://clinicaltrials.gov/show/NCT01872949

Link

https://clinicaltrials.gov/show/NCT01872949

Palavras-chave

Versões (1)
  1. 17/01/2020 17/01/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

17 de janeiro de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01872949

Inglês

Eligibility Heart Failure NCT01872949

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is 18 years or older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patients with moderate to severe ambulatory heart failure [american college of cardiology/american heart association (acc/aha) stage c; nyha class iii/iv ambulatory], who are refractory to optimal medical therapy
Descrição

Heart failure Ambulatory Moderate Stage | Heart failure Ambulatory Severe Stage | Heart failure Ambulatory Moderate New York Heart Association Classification | Heart failure Ambulatory Severe New York Heart Association Classification | Unresponsive to Therapy Optimal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1561561
UMLS CUI [1,3]
C0205081
UMLS CUI [1,4]
C1306673
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1561561
UMLS CUI [2,3]
C0205082
UMLS CUI [2,4]
C1306673
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1561561
UMLS CUI [3,3]
C0205081
UMLS CUI [3,4]
C1275491
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C1561561
UMLS CUI [4,3]
C0205082
UMLS CUI [4,4]
C1275491
UMLS CUI [5,1]
C0205269
UMLS CUI [5,2]
C0087111
UMLS CUI [5,3]
C2698651
patients who are non-responders to crt pacemaker therapy
Descrição

Non-responder Cardiac Resynchronization Therapy Pacemaker (CRT-P)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0919875
UMLS CUI [1,2]
C1737639
patient has signed and dated the investigation informed consent form
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of significant ascending aortic calcification on postero-anterior chest x-ray or ct scan
Descrição

Calcification of the aorta Ascending Chest X-ray Postero-Anterior | Calcification of the aorta Ascending CT scan Postero-Anterior

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1096249
UMLS CUI [1,2]
C0205385
UMLS CUI [1,3]
C0039985
UMLS CUI [1,4]
C1996865
UMLS CUI [2,1]
C1096249
UMLS CUI [2,2]
C0205385
UMLS CUI [2,3]
C0040405
UMLS CUI [2,4]
C1996865
moderate or severe atherosclerotic aortic disease
Descrição

Aortic Disease atherosclerotic moderate | Aortic Disease atherosclerotic severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003493
UMLS CUI [1,2]
C0333482
UMLS CUI [1,3]
C0205081
UMLS CUI [2,1]
C0003493
UMLS CUI [2,2]
C0333482
UMLS CUI [2,3]
C0205082
ascending aorto-coronary artery bypass grafts
Descrição

Coronary Artery Bypass Surgery Aortic Ascending

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C0003483
UMLS CUI [1,3]
C0205385
any history of aortic dissection
Descrição

Dissection of aorta

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0340643
connective tissue disorder such as marfans disease
Descrição

Connective Tissue Disease | Marfan Syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009782
UMLS CUI [2]
C0024796
aorta not conforming to specified dimensional constraints
Descrição

Aorta Inconsistent Dimension Limitation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003483
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C0439534
UMLS CUI [1,4]
C0449295
patient has severe mitral valve incompetence, grade 4+
Descrição

Mitral Valve Insufficiency Severe Grade

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0026266
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0441800
patient has moderate to severe aortic valve incompetence, grade 2 - 4+
Descrição

Aortic Valve Insufficiency Moderate Grade | Aortic Valve Insufficiency Severe Grade

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003504
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0441800
UMLS CUI [2,1]
C0003504
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0441800
patient has systolic blood pressure less than 90 or greater than 140mmhg
Descrição

Systolic Pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0871470
presence of active systemic infection
Descrição

Sepsis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0243026
presence of bleeding or coagulation disorder (relative)
Descrição

Hemorrhage | Blood Coagulation Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C0005779
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Similar models

Eligibility Heart Failure NCT01872949

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is 18 years or older
boolean
C0001779 (UMLS CUI [1])
Heart failure Ambulatory Moderate Stage | Heart failure Ambulatory Severe Stage | Heart failure Ambulatory Moderate New York Heart Association Classification | Heart failure Ambulatory Severe New York Heart Association Classification | Unresponsive to Therapy Optimal
Item
patients with moderate to severe ambulatory heart failure [american college of cardiology/american heart association (acc/aha) stage c; nyha class iii/iv ambulatory], who are refractory to optimal medical therapy
boolean
C0018801 (UMLS CUI [1,1])
C1561561 (UMLS CUI [1,2])
C0205081 (UMLS CUI [1,3])
C1306673 (UMLS CUI [1,4])
C0018801 (UMLS CUI [2,1])
C1561561 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C1306673 (UMLS CUI [2,4])
C0018801 (UMLS CUI [3,1])
C1561561 (UMLS CUI [3,2])
C0205081 (UMLS CUI [3,3])
C1275491 (UMLS CUI [3,4])
C0018801 (UMLS CUI [4,1])
C1561561 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C1275491 (UMLS CUI [4,4])
C0205269 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C2698651 (UMLS CUI [5,3])
Non-responder Cardiac Resynchronization Therapy Pacemaker (CRT-P)
Item
patients who are non-responders to crt pacemaker therapy
boolean
C0919875 (UMLS CUI [1,1])
C1737639 (UMLS CUI [1,2])
Informed Consent
Item
patient has signed and dated the investigation informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Calcification of the aorta Ascending Chest X-ray Postero-Anterior | Calcification of the aorta Ascending CT scan Postero-Anterior
Item
evidence of significant ascending aortic calcification on postero-anterior chest x-ray or ct scan
boolean
C1096249 (UMLS CUI [1,1])
C0205385 (UMLS CUI [1,2])
C0039985 (UMLS CUI [1,3])
C1996865 (UMLS CUI [1,4])
C1096249 (UMLS CUI [2,1])
C0205385 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C1996865 (UMLS CUI [2,4])
Aortic Disease atherosclerotic moderate | Aortic Disease atherosclerotic severe
Item
moderate or severe atherosclerotic aortic disease
boolean
C0003493 (UMLS CUI [1,1])
C0333482 (UMLS CUI [1,2])
C0205081 (UMLS CUI [1,3])
C0003493 (UMLS CUI [2,1])
C0333482 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
Coronary Artery Bypass Surgery Aortic Ascending
Item
ascending aorto-coronary artery bypass grafts
boolean
C0010055 (UMLS CUI [1,1])
C0003483 (UMLS CUI [1,2])
C0205385 (UMLS CUI [1,3])
Dissection of aorta
Item
any history of aortic dissection
boolean
C0340643 (UMLS CUI [1])
Connective Tissue Disease | Marfan Syndrome
Item
connective tissue disorder such as marfans disease
boolean
C0009782 (UMLS CUI [1])
C0024796 (UMLS CUI [2])
Aorta Inconsistent Dimension Limitation
Item
aorta not conforming to specified dimensional constraints
boolean
C0003483 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C0439534 (UMLS CUI [1,3])
C0449295 (UMLS CUI [1,4])
Mitral Valve Insufficiency Severe Grade
Item
patient has severe mitral valve incompetence, grade 4+
boolean
C0026266 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Aortic Valve Insufficiency Moderate Grade | Aortic Valve Insufficiency Severe Grade
Item
patient has moderate to severe aortic valve incompetence, grade 2 - 4+
boolean
C0003504 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0003504 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0441800 (UMLS CUI [2,3])
Systolic Pressure
Item
patient has systolic blood pressure less than 90 or greater than 140mmhg
boolean
C0871470 (UMLS CUI [1])
Sepsis
Item
presence of active systemic infection
boolean
C0243026 (UMLS CUI [1])
Hemorrhage | Blood Coagulation Disorders
Item
presence of bleeding or coagulation disorder (relative)
boolean
C0019080 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
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