ID

37522

Description

Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01486316

Lien

https://clinicaltrials.gov/show/NCT01486316

Mots-clés

Versions (1)
  1. 04/08/2019 04/08/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

4 août 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Atrial Fibrillation NCT01486316

Anglais

Eligibility Atrial Fibrillation NCT01486316

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is 18 years of age or older
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
patient (or patient's legally authorized representative) is willing and able to provide written informed consent
Description

Informed Consent | Informed Consent Patient Representative

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
patient is willing and able to comply with the protocol, including follow-up visits
Description

Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0525058
documented paroxysmal or persistent atrial fibrillation or strong suspicion of atrial fibrillation (i.e, palpitations)
Description

Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Suspicion Strong Atrial Fibrillation | Palpitations

Type de données

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C2585653
UMLS CUI [3,1]
C0242114
UMLS CUI [3,2]
C0442821
UMLS CUI [3,3]
C0004238
UMLS CUI [4]
C0030252
patient is indicated for the reveal xt insertable cardiac monitor or other commercially-available and substantially equivalent medtronic insertable cardiac monitor
Description

Indication Implantable cardiac monitor Specified | Indication Implantable cardiac monitor Equivalent

Type de données

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C3879681
UMLS CUI [1,3]
C0205369
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C3879681
UMLS CUI [2,3]
C0205163
recent hf event within prior 120 days (hf event defined as meeting any one of the following two criteria: 1. admission with primary diagnosis of hf 2. intravenous hf therapy (e.g. iv diuretics/vasodilators) or ultrafiltration at any one of the following settings: admission with secondary/tertiary diagnosis of hf, emergency department, ambulance, observation unit, urgent care, hf/cardiology clinic, patient's home
Description

Heart failure Event Recent | Hospital admission Heart failure | Intravenous therapy Heart failure | Diuretics Intravenous | Intravenous vasodilator | Ultrafiltration | Hospital admission Secondary diagnosis Heart failure | Hospital admission Diagnosis Tertiary Heart failure | Emergency room admission | Ambulance | Observation unit | Urgent Care | Referral to heart failure clinic | Cardiology clinic | Home care of patient

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0184666
UMLS CUI [2,2]
C0018801
UMLS CUI [3,1]
C0455142
UMLS CUI [3,2]
C0018801
UMLS CUI [4,1]
C0012798
UMLS CUI [4,2]
C1522726
UMLS CUI [5]
C0443081
UMLS CUI [6]
C0041612
UMLS CUI [7,1]
C0184666
UMLS CUI [7,2]
C0332138
UMLS CUI [7,3]
C0018801
UMLS CUI [8,1]
C0184666
UMLS CUI [8,2]
C0011900
UMLS CUI [8,3]
C0205372
UMLS CUI [8,4]
C0018801
UMLS CUI [9]
C0583237
UMLS CUI [10]
C0002422
UMLS CUI [11]
C4284828
UMLS CUI [12]
C2362545
UMLS CUI [13]
C1277209
UMLS CUI [14]
C3810847
UMLS CUI [15]
C0204977
willing and able to transmit data via carelink
Description

Data Transmission Willing | Other Coding

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332289
UMLS CUI [1,2]
C0600109
UMLS CUI [2]
C3846158
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is pregnant
Description

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
patient has been participating in another study that may interfere with the identify-hf protocol required procedures
Description

Study Subject Participation Status Interferes with Study Protocol Procedures

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C0184661
endstage (stage d or new york heart association class iv) heart failure
Description

End stage cardiac failure | Heart failure Stage | Heart failure New York Heart Association Classification

Type de données

boolean

Alias
UMLS CUI [1]
C1868938
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1306673
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1275491
asymptomatic (stage b or new york heart association class i) heart failure
Description

Heart failure Asymptomatic Stage | Heart failure Asymptomatic New York Heart Association Classification

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231221
UMLS CUI [1,3]
C1306673
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0231221
UMLS CUI [2,3]
C1275491
severe aortic stenosis or insufficiency
Description

Aortic stenosis, severe | Aortic Insufficiency Severe

Type de données

boolean

Alias
UMLS CUI [1]
C3806272
UMLS CUI [2,1]
C0003504
UMLS CUI [2,2]
C0205082
existing insertable cardiac monitor implanted for more than 1 year
Description

Implantable cardiac monitor insertion

Type de données

boolean

Alias
UMLS CUI [1]
C3805086
existing implantable pulse generator, implantable cardioverter defibrillator, cardiac resynchronization therapy device
Description

Pulse Generator Present | Implantable cardioverter-defibrillator Present | Cardiac Resynchronization Therapy Device Present

Type de données

boolean

Alias
UMLS CUI [1,1]
C1140627
UMLS CUI [1,2]
C0150312
UMLS CUI [2,1]
C0162589
UMLS CUI [2,2]
C0150312
UMLS CUI [3,1]
C2936377
UMLS CUI [3,2]
C0150312
severe renal impairment (estimated glomerular filtration rate <25ml/min)
Description

Renal Insufficiency Severe | Estimated Glomerular Filtration Rate

Type de données

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C3811844
myocardial infarction within prior 30 days
Description

Myocardial Infarction

Type de données

boolean

Alias
UMLS CUI [1]
C0027051
Retour au début de la page

Similar models

Eligibility Atrial Fibrillation NCT01486316

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representative
Item
patient (or patient's legally authorized representative) is willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Protocol Compliance
Item
patient is willing and able to comply with the protocol, including follow-up visits
boolean
C0525058 (UMLS CUI [1])
Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Suspicion Strong Atrial Fibrillation | Palpitations
Item
documented paroxysmal or persistent atrial fibrillation or strong suspicion of atrial fibrillation (i.e, palpitations)
boolean
C0235480 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
C0242114 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
C0004238 (UMLS CUI [3,3])
C0030252 (UMLS CUI [4])
Indication Implantable cardiac monitor Specified | Indication Implantable cardiac monitor Equivalent
Item
patient is indicated for the reveal xt insertable cardiac monitor or other commercially-available and substantially equivalent medtronic insertable cardiac monitor
boolean
C3146298 (UMLS CUI [1,1])
C3879681 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C3879681 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
Heart failure Event Recent | Hospital admission Heart failure | Intravenous therapy Heart failure | Diuretics Intravenous | Intravenous vasodilator | Ultrafiltration | Hospital admission Secondary diagnosis Heart failure | Hospital admission Diagnosis Tertiary Heart failure | Emergency room admission | Ambulance | Observation unit | Urgent Care | Referral to heart failure clinic | Cardiology clinic | Home care of patient
Item
recent hf event within prior 120 days (hf event defined as meeting any one of the following two criteria: 1. admission with primary diagnosis of hf 2. intravenous hf therapy (e.g. iv diuretics/vasodilators) or ultrafiltration at any one of the following settings: admission with secondary/tertiary diagnosis of hf, emergency department, ambulance, observation unit, urgent care, hf/cardiology clinic, patient's home
boolean
C0018801 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0184666 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
C0455142 (UMLS CUI [3,1])
C0018801 (UMLS CUI [3,2])
C0012798 (UMLS CUI [4,1])
C1522726 (UMLS CUI [4,2])
C0443081 (UMLS CUI [5])
C0041612 (UMLS CUI [6])
C0184666 (UMLS CUI [7,1])
C0332138 (UMLS CUI [7,2])
C0018801 (UMLS CUI [7,3])
C0184666 (UMLS CUI [8,1])
C0011900 (UMLS CUI [8,2])
C0205372 (UMLS CUI [8,3])
C0018801 (UMLS CUI [8,4])
C0583237 (UMLS CUI [9])
C0002422 (UMLS CUI [10])
C4284828 (UMLS CUI [11])
C2362545 (UMLS CUI [12])
C1277209 (UMLS CUI [13])
C3810847 (UMLS CUI [14])
C0204977 (UMLS CUI [15])
Data Transmission Willing | Other Coding
Item
willing and able to transmit data via carelink
boolean
C0332289 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
patient is pregnant
boolean
C0032961 (UMLS CUI [1])
Study Subject Participation Status Interferes with Study Protocol Procedures
Item
patient has been participating in another study that may interfere with the identify-hf protocol required procedures
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
End stage cardiac failure | Heart failure Stage | Heart failure New York Heart Association Classification
Item
endstage (stage d or new york heart association class iv) heart failure
boolean
C1868938 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1306673 (UMLS CUI [2,2])
C0018801 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
Heart failure Asymptomatic Stage | Heart failure Asymptomatic New York Heart Association Classification
Item
asymptomatic (stage b or new york heart association class i) heart failure
boolean
C0018801 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C1306673 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
Aortic stenosis, severe | Aortic Insufficiency Severe
Item
severe aortic stenosis or insufficiency
boolean
C3806272 (UMLS CUI [1])
C0003504 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Implantable cardiac monitor insertion
Item
existing insertable cardiac monitor implanted for more than 1 year
boolean
C3805086 (UMLS CUI [1])
Pulse Generator Present | Implantable cardioverter-defibrillator Present | Cardiac Resynchronization Therapy Device Present
Item
existing implantable pulse generator, implantable cardioverter defibrillator, cardiac resynchronization therapy device
boolean
C1140627 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0162589 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
C2936377 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
Renal Insufficiency Severe | Estimated Glomerular Filtration Rate
Item
severe renal impairment (estimated glomerular filtration rate <25ml/min)
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
Myocardial Infarction
Item
myocardial infarction within prior 30 days
boolean
C0027051 (UMLS CUI [1])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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