ID

35196

Description

Investigation of the Safety and Feasibility of AAV1/SERCA2a Gene Transfer in Patients With Chronic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00534703

Link

https://clinicaltrials.gov/show/NCT00534703

Keywords

Versions (1)
  1. 2/23/19 2/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 23, 2019

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 Chronic Heart Failure NCT00534703

English

Eligibility Chronic Heart Failure NCT00534703

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients that have had a left ventricular assist device (lvad) implanted for chronic heart failure, where chronic heart failure is defined as at least 6 months
Description

Implantation of left ventricular assist device | Chronic heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0397130
UMLS CUI [2]
C0264716
patients are clinically stable in the opinion of the clinical team looking after the patient
Description

Clinical status Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0449440
UMLS CUI [1,2]
C0205360
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
<18 or >70 years of age at the time of consent
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
pregnancy or within 6 months of giving birth
Description

Pregnancy | Birth

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0005615
women of child-bearing potential not using an effective method of contraception
Description

Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
men not using an effective method of contraception
Description

Gender Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
suspected or active viral, fungal or parasitic infection within 48 hours prior to administration of imp, in the opinion of the investigator*.
Description

Virus Disease Suspected | Mycoses Suspected | Parasitic infection Suspected

Data type

boolean

Alias
UMLS CUI [1,1]
C0042769
UMLS CUI [1,2]
C0750491
UMLS CUI [2,1]
C0026946
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C0747256
UMLS CUI [3,2]
C0750491
patients at a high risk of thrombosis in the opinion of the investigator
Description

High risk of Thrombosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0040053
patients with a previous episode of lvad thrombosis
Description

Episode Previous LVAD Thrombosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0181598
UMLS CUI [1,4]
C0040053
patients with persistently raised lactate dehydrogenase (ldh >2.5 uln)
Description

Serum lactate dehydrogenase level elevated Persistent

Data type

boolean

Alias
UMLS CUI [1,1]
C1275604
UMLS CUI [1,2]
C0205322
patients requiring triple anticoagulation i.e. warfarin and dual anti-platelet
Description

Patient need for Anticoagulation Therapy Triple | Warfarin | Antiplatelet Agents Dual

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0003281
UMLS CUI [1,3]
C0205174
UMLS CUI [2]
C0043031
UMLS CUI [3,1]
C0085826
UMLS CUI [3,2]
C0205173
patients participating in another clinical trial
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
patients unable to comply with the protocol mandated procedures for social or other reasons, in the opinion of the investigator and primary care physician
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
eligible, enrolled and randomised patients who develop an infection will have study treatment delayed until 7 or more days after the time point when infection is no longer clinically evident.
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
Back to the top of the page

Similar models

Eligibility Chronic Heart Failure NCT00534703

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Implantation of left ventricular assist device | Chronic heart failure
Item
patients that have had a left ventricular assist device (lvad) implanted for chronic heart failure, where chronic heart failure is defined as at least 6 months
boolean
C0397130 (UMLS CUI [1])
C0264716 (UMLS CUI [2])
Clinical status Stable
Item
patients are clinically stable in the opinion of the clinical team looking after the patient
boolean
C0449440 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
<18 or >70 years of age at the time of consent
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Birth
Item
pregnancy or within 6 months of giving birth
boolean
C0032961 (UMLS CUI [1])
C0005615 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent
Item
women of child-bearing potential not using an effective method of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Gender Contraceptive methods Absent
Item
men not using an effective method of contraception
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Virus Disease Suspected | Mycoses Suspected | Parasitic infection Suspected
Item
suspected or active viral, fungal or parasitic infection within 48 hours prior to administration of imp, in the opinion of the investigator*.
boolean
C0042769 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0026946 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0747256 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
High risk of Thrombosis
Item
patients at a high risk of thrombosis in the opinion of the investigator
boolean
C0332167 (UMLS CUI [1,1])
C0040053 (UMLS CUI [1,2])
Episode Previous LVAD Thrombosis
Item
patients with a previous episode of lvad thrombosis
boolean
C0332189 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0181598 (UMLS CUI [1,3])
C0040053 (UMLS CUI [1,4])
Serum lactate dehydrogenase level elevated Persistent
Item
patients with persistently raised lactate dehydrogenase (ldh >2.5 uln)
boolean
C1275604 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
Patient need for Anticoagulation Therapy Triple | Warfarin | Antiplatelet Agents Dual
Item
patients requiring triple anticoagulation i.e. warfarin and dual anti-platelet
boolean
C0686904 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0205174 (UMLS CUI [1,3])
C0043031 (UMLS CUI [2])
C0085826 (UMLS CUI [3,1])
C0205173 (UMLS CUI [3,2])
Study Subject Participation Status
Item
patients participating in another clinical trial
boolean
C2348568 (UMLS CUI [1])
Protocol Compliance Unable
Item
patients unable to comply with the protocol mandated procedures for social or other reasons, in the opinion of the investigator and primary care physician
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Communicable Disease
Item
eligible, enrolled and randomised patients who develop an infection will have study treatment delayed until 7 or more days after the time point when infection is no longer clinically evident.
boolean
C0009450 (UMLS CUI [1])
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