ID

35196

Descripción

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

Palabras clave

Versiones (1)
  1. 23/2/19 23/2/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

23 de febrero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Chronic Heart Failure NCT00534703

Inglés

Eligibility Chronic Heart Failure NCT00534703

1 formularios  
Inclusion Criteria
Descripción

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
Descripción

Implantation of left ventricular assist device | Chronic heart failure

Tipo de datos

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
Descripción

Clinical status Stable

Tipo de datos

boolean

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

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

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

Age

Tipo de datos

boolean

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

Pregnancy | Birth

Tipo de datos

boolean

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

Childbearing Potential Contraceptive methods Absent

Tipo de datos

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
Descripción

Gender Contraceptive methods Absent

Tipo de datos

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*.
Descripción

Virus Disease Suspected | Mycoses Suspected | Parasitic infection Suspected

Tipo de datos

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
Descripción

High risk of Thrombosis

Tipo de datos

boolean

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

Episode Previous LVAD Thrombosis

Tipo de datos

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)
Descripción

Serum lactate dehydrogenase level elevated Persistent

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

Study Subject Participation Status

Tipo de datos

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
Descripción

Protocol Compliance Unable

Tipo de datos

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.
Descripción

Communicable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
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Similar models

Eligibility Chronic Heart Failure NCT00534703

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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