ID

39401

Beschrijving

INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored Implanted Cardioverter Defibrillators (ICD) SysTems; ODM derived from: https://clinicaltrials.gov/show/NCT01200381

Link

https://clinicaltrials.gov/show/NCT01200381

Trefwoorden

  1. 08-01-20 08-01-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

8 januari 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Heart Failure NCT01200381

Eligibility Heart Failure NCT01200381

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
indication for implantation (new, boxchange, upgrade) of icd/ crt-d
Beschrijving

Indication ICD Placement | Indication Implantation of CRT-D

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2825184
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1135480
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
ejection fraction <= 35%
Beschrijving

Cardiac ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0232174
new york heart association (nyha) class i-iii
Beschrijving

New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1]
C1275491
age >=18 and <=80 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
in patient's home environment sufficient infrastructure (analog phone line or sufficient strength of gsm (global system for mobile communication) mobile phone network) for running a merlin@home transmitter is available
Beschrijving

Availability of Mobile Phone Network

Datatype

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C1136360
UMLS CUI [1,3]
C1882071
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
arterio ventricular (av) block iii / av block ii type mobitz
Beschrijving

Complete atrioventricular block | Mobitz type II atrioventricular block

Datatype

boolean

Alias
UMLS CUI [1]
C0151517
UMLS CUI [2]
C0155700
severe renal insufficiency
Beschrijving

Renal Insufficiency Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
coronary angiology intervention within previous 3 months
Beschrijving

Coronary angiography

Datatype

boolean

Alias
UMLS CUI [1]
C0085532
myocardial infarction within previous month
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
life expectancy < 1 year
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
expected poor data quality / compliance
Beschrijving

Data Quality Poor Expected | Poor compliance Expected

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242483
UMLS CUI [1,2]
C0542537
UMLS CUI [1,3]
C1517001
UMLS CUI [2,1]
C0032646
UMLS CUI [2,2]
C1517001
pregnancy
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
patient is already participating to another study with active therapy arm
Beschrijving

Study Subject Participation Status | Clinical Trial Treatment Arm

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C1522541

Similar models

Eligibility Heart Failure NCT01200381

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Indication ICD Placement | Indication Implantation of CRT-D
Item
indication for implantation (new, boxchange, upgrade) of icd/ crt-d
boolean
C3146298 (UMLS CUI [1,1])
C2825184 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C1135480 (UMLS CUI [2,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Cardiac ejection fraction
Item
ejection fraction <= 35%
boolean
C0232174 (UMLS CUI [1])
New York Heart Association Classification
Item
new york heart association (nyha) class i-iii
boolean
C1275491 (UMLS CUI [1])
Age
Item
age >=18 and <=80 years
boolean
C0001779 (UMLS CUI [1])
Availability of Mobile Phone Network
Item
in patient's home environment sufficient infrastructure (analog phone line or sufficient strength of gsm (global system for mobile communication) mobile phone network) for running a merlin@home transmitter is available
boolean
C0470187 (UMLS CUI [1,1])
C1136360 (UMLS CUI [1,2])
C1882071 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Complete atrioventricular block | Mobitz type II atrioventricular block
Item
arterio ventricular (av) block iii / av block ii type mobitz
boolean
C0151517 (UMLS CUI [1])
C0155700 (UMLS CUI [2])
Renal Insufficiency Severe
Item
severe renal insufficiency
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Coronary angiography
Item
coronary angiology intervention within previous 3 months
boolean
C0085532 (UMLS CUI [1])
Myocardial Infarction
Item
myocardial infarction within previous month
boolean
C0027051 (UMLS CUI [1])
Life Expectancy
Item
life expectancy < 1 year
boolean
C0023671 (UMLS CUI [1])
Data Quality Poor Expected | Poor compliance Expected
Item
expected poor data quality / compliance
boolean
C0242483 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C0032646 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trial Treatment Arm
Item
patient is already participating to another study with active therapy arm
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1522541 (UMLS CUI [2,2])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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