ID

39487

Description

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

Link

https://clinicaltrials.gov/show/NCT01872949

Keywords

Versions (1)
  1. 1/17/20 1/17/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 17, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Heart Failure NCT01872949

English

Eligibility Heart Failure NCT01872949

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is 18 years or older
Description

Age

Data type

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
Description

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

Data type

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
Description

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

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

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

Data type

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
Description

Aortic Disease atherosclerotic moderate | Aortic Disease atherosclerotic severe

Data type

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
Description

Coronary Artery Bypass Surgery Aortic Ascending

Data type

boolean

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

Dissection of aorta

Data type

boolean

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

Connective Tissue Disease | Marfan Syndrome

Data type

boolean

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

Aorta Inconsistent Dimension Limitation

Data type

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+
Description

Mitral Valve Insufficiency Severe Grade

Data type

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+
Description

Aortic Valve Insufficiency Moderate Grade | Aortic Valve Insufficiency Severe Grade

Data type

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
Description

Systolic Pressure

Data type

boolean

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

Sepsis

Data type

boolean

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

Hemorrhage | Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C0005779
Back to the top of the page

Similar models

Eligibility Heart Failure NCT01872949

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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