ID

37598

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01976507

Trefwoorden

Versies (1)
  1. 10-08-19 10-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01976507

Engels

Eligibility Atrial Fibrillation NCT01976507

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

boolean

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

Childbearing Potential Pregnancy test negative

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

CHADS2 score | CHA2DS2-VASc score

Datatype

boolean

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

Hemostasis Vascular | Other Coding

Datatype

boolean

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

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
unable to give informed consent
Beschrijving

Informed Consent Unable

Datatype

boolean

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

Study Subject Participation Status | Therapy, Investigational

Datatype

boolean

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

Hemophilia Hereditary

Datatype

boolean

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

Hemorrhage

Datatype

boolean

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

Kidney Failure, Chronic | Creatinine clearance measurement

Datatype

boolean

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

Dabigatran failed | Cerebrovascular accident | Thromboembolism Systemic

Datatype

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
Beschrijving

Allergic Reaction Dabigatran etexilate

Datatype

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.
Beschrijving

Intolerance to Dabigatran | Pharmaceutical Preparations Absent | Medical contraindication

Datatype

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
Beschrijving

Pregnancy

Datatype

boolean

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

Compliance behavior Lacking

Datatype

boolean

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

Follow-up Unable

Datatype

boolean

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

Eligibility Atrial Fibrillation NCT01976507

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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