ID

39472

Description

Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement; ODM derived from: https://clinicaltrials.gov/show/NCT01711281

Lien

https://clinicaltrials.gov/show/NCT01711281

Mots-clés

  1. 14/01/2020 14/01/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

14 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.

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 NCT01711281

Eligibility Heart Failure NCT01711281

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
de novo crt-patients
Description

Cardiac Resynchronization Therapy de novo

Type de données

boolean

Alias
UMLS CUI [1,1]
C1167956
UMLS CUI [1,2]
C1515568
planned implantation with a lumax 740 hf-t device, a bipolar lv-lead and a true bipolar rv-lead
Description

Implantation of CRT-D Specified Planned | implantable cardioverter-defibrillator left ventricular lead Bipolar | implantable cardioverter-defibrillator right ventricular lead Bipolar

Type de données

boolean

Alias
UMLS CUI [1,1]
C1135480
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C2048278
UMLS CUI [2,2]
C0443156
UMLS CUI [3,1]
C2048371
UMLS CUI [3,2]
C0443156
nyha class ii or iii
Description

New York Heart Association Classification

Type de données

boolean

Alias
UMLS CUI [1]
C1275491
qrs ≥ 150 ms
Description

QRS duration

Type de données

boolean

Alias
UMLS CUI [1]
C0429025
lvef between 15% and 35%
Description

Left ventricular ejection fraction

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
lvedd ≥ 55 mm
Description

Left ventricular end-diastolic dimension

Type de données

boolean

Alias
UMLS CUI [1]
C1142231
evaluable echo measurements
Description

Echocardiography

Type de données

boolean

Alias
UMLS CUI [1]
C0013516
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
persistent or permanent atrial fibrillation
Description

Persistent atrial fibrillation | Permanent atrial fibrillation

Type de données

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2]
C2586056
heart surgery within the previous 3 months or planned for the time of study participation; post-heart transplantation or listed for heart transplantation
Description

Cardiac Surgery | Cardiac Surgery Planned | Status post Heart Transplantation | Patient on waiting list Heart Transplantation

Type de données

boolean

Alias
UMLS CUI [1]
C0018821
UMLS CUI [2,1]
C0018821
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0018823
UMLS CUI [4,1]
C0422768
UMLS CUI [4,2]
C0018823
non-ambulatory patients
Description

Lacking Able to walk

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712089
chronic renal dialysis
Description

Dialysis chronic

Type de données

boolean

Alias
UMLS CUI [1]
C0743165
life expectancy less than 1 year due to a non-cardiac disease
Description

Life Expectancy Due to Disease | Exception Heart Disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0012634
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
age < 18 years and/or limited contractual capability
Description

Age | Legal capacity Limited

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0439801
addiction to alcohol, medical drugs or illegal drugs
Description

Alcoholic Intoxication, Chronic | Drug Addiction | Illicit Drug Addiction

Type de données

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0085281
UMLS CUI [3,1]
C0086190
UMLS CUI [3,2]
C0085281
pregnant or breast-feeding women
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participation in another clinical trial
Description

Study Subject Participation Status | Clinical Trial

Type de données

boolean

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

Similar models

Eligibility Heart Failure NCT01711281

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Cardiac Resynchronization Therapy de novo
Item
de novo crt-patients
boolean
C1167956 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
Implantation of CRT-D Specified Planned | implantable cardioverter-defibrillator left ventricular lead Bipolar | implantable cardioverter-defibrillator right ventricular lead Bipolar
Item
planned implantation with a lumax 740 hf-t device, a bipolar lv-lead and a true bipolar rv-lead
boolean
C1135480 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C2048278 (UMLS CUI [2,1])
C0443156 (UMLS CUI [2,2])
C2048371 (UMLS CUI [3,1])
C0443156 (UMLS CUI [3,2])
New York Heart Association Classification
Item
nyha class ii or iii
boolean
C1275491 (UMLS CUI [1])
QRS duration
Item
qrs ≥ 150 ms
boolean
C0429025 (UMLS CUI [1])
Left ventricular ejection fraction
Item
lvef between 15% and 35%
boolean
C0428772 (UMLS CUI [1])
Left ventricular end-diastolic dimension
Item
lvedd ≥ 55 mm
boolean
C1142231 (UMLS CUI [1])
Echocardiography
Item
evaluable echo measurements
boolean
C0013516 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Persistent atrial fibrillation | Permanent atrial fibrillation
Item
persistent or permanent atrial fibrillation
boolean
C2585653 (UMLS CUI [1])
C2586056 (UMLS CUI [2])
Cardiac Surgery | Cardiac Surgery Planned | Status post Heart Transplantation | Patient on waiting list Heart Transplantation
Item
heart surgery within the previous 3 months or planned for the time of study participation; post-heart transplantation or listed for heart transplantation
boolean
C0018821 (UMLS CUI [1])
C0018821 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0018823 (UMLS CUI [3,2])
C0422768 (UMLS CUI [4,1])
C0018823 (UMLS CUI [4,2])
Lacking Able to walk
Item
non-ambulatory patients
boolean
C0332268 (UMLS CUI [1,1])
C2712089 (UMLS CUI [1,2])
Dialysis chronic
Item
chronic renal dialysis
boolean
C0743165 (UMLS CUI [1])
Life Expectancy Due to Disease | Exception Heart Disease
Item
life expectancy less than 1 year due to a non-cardiac disease
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
Age | Legal capacity Limited
Item
age < 18 years and/or limited contractual capability
boolean
C0001779 (UMLS CUI [1])
C0683673 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Alcoholic Intoxication, Chronic | Drug Addiction | Illicit Drug Addiction
Item
addiction to alcohol, medical drugs or illegal drugs
boolean
C0001973 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0085281 (UMLS CUI [2,2])
C0086190 (UMLS CUI [3,1])
C0085281 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial
Item
participation in another clinical trial
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])

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

Les champs marqués d’un * sont obligatoires.

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