ID

37598

Descripción

Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism; ODM derived from: https://clinicaltrials.gov/show/NCT01976507

Link

https://clinicaltrials.gov/show/NCT01976507

Palabras clave

Versiones (1)
  1. 10/8/19 10/8/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

10 de agosto de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01976507

Inglés

Eligibility Atrial Fibrillation NCT01976507

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female sex, age 18-85 years.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
negative pregnancy test for women of childbearing potential
Descripción

Childbearing Potential Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
planned pulmonary vein isolation by antral radiofrequency or cryoablation for paroxysmal or persistent atrial fibrillation, non-valvular atrial fibrillation (nvaf), or left atrial flutter following prior left atrial ablation procedures
Descripción

Pulmonary vein isolation Radiofrequency Antral | Pulmonary vein isolation Cryosurgery | Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Atrial Fibrillation | Atrial Flutter Left | Status post Atrial Ablation Left

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3544330
UMLS CUI [1,2]
C0579006
UMLS CUI [1,3]
C0737254
UMLS CUI [2,1]
C3544330
UMLS CUI [2,2]
C0010408
UMLS CUI [3]
C0235480
UMLS CUI [4]
C2585653
UMLS CUI [5]
C0004238
UMLS CUI [6,1]
C0004239
UMLS CUI [6,2]
C0205091
UMLS CUI [7,1]
C0231290
UMLS CUI [7,2]
C2825182
UMLS CUI [7,3]
C0205091
chads2 score of 0-6 or chads2-vasc score 0-9
Descripción

CHADS2 score | CHA2DS2-VASc score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2585876
UMLS CUI [2]
C4049268
vascular hemostasis within 4-6 hours of sheath pull
Descripción

Hemostasis Vascular | Other Coding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019116
UMLS CUI [1,2]
C1801960
UMLS CUI [2]
C3846158
able to give informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
unable to give informed consent
Descripción

Informed Consent Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
currently participating in another clinical treatment trial
Descripción

Study Subject Participation Status | Therapy, Investigational

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
history of hereditary hemophilias
Descripción

Hemophilia Hereditary

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0684275
UMLS CUI [1,2]
C0439660
presence of active bleeding
Descripción

Hemorrhage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019080
end stage renal disease, crcl<15 ml/min
Descripción

Kidney Failure, Chronic | Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0373595
prior treatment failure of dabigatran (stroke or systemic thromboembolism while on therapeutic dabigatran)
Descripción

Dabigatran failed | Cerebrovascular accident | Thromboembolism Systemic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348066
UMLS CUI [1,2]
C0231175
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0040038
UMLS CUI [3,2]
C0205373
known allergic reaction to dabigatran etexilate
Descripción

Allergic Reaction Dabigatran etexilate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1571583
intolerance to dabigatran, if medication naïve, or other contra-indications as per the uspi.
Descripción

Intolerance to Dabigatran | Pharmaceutical Preparations Absent | Medical contraindication

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C2348066
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C1301624
pregnancy
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
history of non-compliance
Descripción

Compliance behavior Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332268
inability to follow-up
Descripción

Follow-up Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Atrial Fibrillation NCT01976507

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female sex, age 18-85 years.
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
negative pregnancy test for women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Pulmonary vein isolation Radiofrequency Antral | Pulmonary vein isolation Cryosurgery | Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Atrial Fibrillation | Atrial Flutter Left | Status post Atrial Ablation Left
Item
planned pulmonary vein isolation by antral radiofrequency or cryoablation for paroxysmal or persistent atrial fibrillation, non-valvular atrial fibrillation (nvaf), or left atrial flutter following prior left atrial ablation procedures
boolean
C3544330 (UMLS CUI [1,1])
C0579006 (UMLS CUI [1,2])
C0737254 (UMLS CUI [1,3])
C3544330 (UMLS CUI [2,1])
C0010408 (UMLS CUI [2,2])
C0235480 (UMLS CUI [3])
C2585653 (UMLS CUI [4])
C0004238 (UMLS CUI [5])
C0004239 (UMLS CUI [6,1])
C0205091 (UMLS CUI [6,2])
C0231290 (UMLS CUI [7,1])
C2825182 (UMLS CUI [7,2])
C0205091 (UMLS CUI [7,3])
CHADS2 score | CHA2DS2-VASc score
Item
chads2 score of 0-6 or chads2-vasc score 0-9
boolean
C2585876 (UMLS CUI [1])
C4049268 (UMLS CUI [2])
Hemostasis Vascular | Other Coding
Item
vascular hemostasis within 4-6 hours of sheath pull
boolean
C0019116 (UMLS CUI [1,1])
C1801960 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Informed Consent
Item
able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
unable to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Study Subject Participation Status | Therapy, Investigational
Item
currently participating in another clinical treatment trial
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Hemophilia Hereditary
Item
history of hereditary hemophilias
boolean
C0684275 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
Hemorrhage
Item
presence of active bleeding
boolean
C0019080 (UMLS CUI [1])
Kidney Failure, Chronic | Creatinine clearance measurement
Item
end stage renal disease, crcl<15 ml/min
boolean
C0022661 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Dabigatran failed | Cerebrovascular accident | Thromboembolism Systemic
Item
prior treatment failure of dabigatran (stroke or systemic thromboembolism while on therapeutic dabigatran)
boolean
C2348066 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2])
C0040038 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
Allergic Reaction Dabigatran etexilate
Item
known allergic reaction to dabigatran etexilate
boolean
C1527304 (UMLS CUI [1,1])
C1571583 (UMLS CUI [1,2])
Intolerance to Dabigatran | Pharmaceutical Preparations Absent | Medical contraindication
Item
intolerance to dabigatran, if medication naïve, or other contra-indications as per the uspi.
boolean
C1744706 (UMLS CUI [1,1])
C2348066 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Compliance behavior Lacking
Item
history of non-compliance
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Follow-up Unable
Item
inability to follow-up
boolean
C3274571 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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