ID

39443

Description

Heart Failure and Risk of Re-Admissions Determined by Abnormal REVEAL Parameters; ODM derived from: https://clinicaltrials.gov/show/NCT01357408

Lien

https://clinicaltrials.gov/show/NCT01357408

Mots-clés

Versions (1)
  1. 10/01/2020 10/01/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

10 janvier 2020

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 Heart Failure NCT01357408

Anglais

Eligibility Heart Failure NCT01357408

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men and non-pregnant/non lactating women ≥ 18 years.
Description

Gender | Age | Pregnancy Absent | Breast Feeding Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0006147
UMLS CUI [4,2]
C0332197
2. admission to hospital or observation unit for worsening heart failure.
Description

Hospital admission Heart failure Worsening

Type de données

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C0332271
3. has a reveal xt device or has plans for a device implant for a clinical indication within 14 days of discharge.
Description

Heart Rate Monitoring System Specified | Indication Device implant

Type de données

boolean

Alias
UMLS CUI [1,1]
C4287153
UMLS CUI [1,2]
C0205369
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0948629
4. ejection fraction ≥40% by echocardiogram within 6 months of enrollment
Description

Cardiac ejection fraction Echocardiography

Type de données

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0013516
5. able to participate in the study for at least 6 months.
Description

Participation Clinical Trial Duration

Type de données

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0449238
6. not currently enrolled in another study.
Description

Absence Enrollment Clinical Trial Other

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1516879
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205394
7. able to provide informed consent and complete scheduled study visits.
Description

Informed Consent | Clinical Trial Visits Completion

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0008952
UMLS CUI [2,3]
C0205197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. has a clinical indication for a therapeutic cardiac device (pacemaker or defibrillator)
Description

Indication Cardiac implant device | Indication Pacemaker | Indication Defibrillator

Type de données

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0581396
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0030163
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0180307
2. history of permanent atrial fibrillation or atrial flutter.
Description

Permanent atrial fibrillation | Atrial Flutter Permanent

Type de données

boolean

Alias
UMLS CUI [1]
C2586056
UMLS CUI [2,1]
C0004239
UMLS CUI [2,2]
C0205355
3. history of uncontrolled hypertension (high blood pressure)
Description

Uncontrolled hypertension

Type de données

boolean

Alias
UMLS CUI [1]
C1868885
4. has a previously implanted cardiac device (pacemaker or defibrillator) in place.
Description

Cardiac implant device Previous | Pacemaker Previous | Defibrillator Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0581396
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0030163
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C0180307
UMLS CUI [3,2]
C0205156
5. stage iv or v chronic renal dysfunction (estimated gfr <25 ml/min per 1.73 m2)
Description

Renal dysfunction chronic Stage | Estimated Glomerular Filtration Rate

Type de données

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C1306673
UMLS CUI [2]
C3811844
6. end-stage (stage d) hf, including chronic ionotropic drugs infusions or left ventricular assist device
Description

End stage cardiac failure | Inotropic agent Infusions chronic | Left ventricular assist device

Type de données

boolean

Alias
UMLS CUI [1]
C1868938
UMLS CUI [2,1]
C0304509
UMLS CUI [2,2]
C0574032
UMLS CUI [2,3]
C0205191
UMLS CUI [3]
C0181598
7. waiting on the transplant list as an unos status 1a or 1b patient
Description

On transplant waiting list | UNOS Status

Type de données

boolean

Alias
UMLS CUI [1]
C3484394
UMLS CUI [2,1]
C3826868
UMLS CUI [2,2]
C0449438
Retour au début de la page

Similar models

Eligibility Heart Failure NCT01357408

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Pregnancy Absent | Breast Feeding Absent
Item
1. men and non-pregnant/non lactating women ≥ 18 years.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0006147 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Hospital admission Heart failure Worsening
Item
2. admission to hospital or observation unit for worsening heart failure.
boolean
C0184666 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0332271 (UMLS CUI [1,3])
Heart Rate Monitoring System Specified | Indication Device implant
Item
3. has a reveal xt device or has plans for a device implant for a clinical indication within 14 days of discharge.
boolean
C4287153 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0948629 (UMLS CUI [2,2])
Cardiac ejection fraction Echocardiography
Item
4. ejection fraction ≥40% by echocardiogram within 6 months of enrollment
boolean
C0232174 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Participation Clinical Trial Duration
Item
5. able to participate in the study for at least 6 months.
boolean
C0679823 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Absence Enrollment Clinical Trial Other
Item
6. not currently enrolled in another study.
boolean
C0332197 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Informed Consent | Clinical Trial Visits Completion
Item
7. able to provide informed consent and complete scheduled study visits.
boolean
C0021430 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0008952 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Indication Cardiac implant device | Indication Pacemaker | Indication Defibrillator
Item
1. has a clinical indication for a therapeutic cardiac device (pacemaker or defibrillator)
boolean
C3146298 (UMLS CUI [1,1])
C0581396 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0030163 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C0180307 (UMLS CUI [3,2])
Permanent atrial fibrillation | Atrial Flutter Permanent
Item
2. history of permanent atrial fibrillation or atrial flutter.
boolean
C2586056 (UMLS CUI [1])
C0004239 (UMLS CUI [2,1])
C0205355 (UMLS CUI [2,2])
Uncontrolled hypertension
Item
3. history of uncontrolled hypertension (high blood pressure)
boolean
C1868885 (UMLS CUI [1])
Cardiac implant device Previous | Pacemaker Previous | Defibrillator Previous
Item
4. has a previously implanted cardiac device (pacemaker or defibrillator) in place.
boolean
C0581396 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0180307 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
Renal dysfunction chronic Stage | Estimated Glomerular Filtration Rate
Item
5. stage iv or v chronic renal dysfunction (estimated gfr <25 ml/min per 1.73 m2)
boolean
C3279454 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1306673 (UMLS CUI [1,3])
C3811844 (UMLS CUI [2])
End stage cardiac failure | Inotropic agent Infusions chronic | Left ventricular assist device
Item
6. end-stage (stage d) hf, including chronic ionotropic drugs infusions or left ventricular assist device
boolean
C1868938 (UMLS CUI [1])
C0304509 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0181598 (UMLS CUI [3])
On transplant waiting list | UNOS Status
Item
7. waiting on the transplant list as an unos status 1a or 1b patient
boolean
C3484394 (UMLS CUI [1])
C3826868 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
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