ID

37496

Beschrijving

Dabigatran's Effect on Changes in Atrial Fibrosis in Patients With Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT01546883

Link

https://clinicaltrials.gov/show/NCT01546883

Trefwoorden

Versies (1)
  1. 02-08-19 02-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

2 augustus 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Atrial Fibrillation NCT01546883

Engels

Eligibility Atrial Fibrillation NCT01546883

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with all types of non-valvular af (includes paroxysmal, persistent and permanent af)
Beschrijving

Atrial Fibrillation Type All | Exception Heart Valve Involvement | Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Permanent atrial fibrillation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0444868
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018826
UMLS CUI [2,3]
C1314939
UMLS CUI [3]
C0235480
UMLS CUI [4]
C2585653
UMLS CUI [5]
C2586056
2. candidate for anticoagulation therapy
Beschrijving

Patient Appropriate Anticoagulation Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0003281
3. no contra-indication for lge-mri
Beschrijving

Medical contraindication Absent Nuclear magnetic resonance imaging gadolinium-enhanced

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0855566
4. patients age 18 and older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
5. patients who are able to provide informed consent to participate in the study
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have already undergone an atrial fibrillation ablation procedure.
Beschrijving

Catheter ablation for atrial fibrillation Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C0205156
2. patients with active contra-indications to any anticoagulant agent.
Beschrijving

Medical contraindication Anticoagulants

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003280
3. other major bleeding disorders or risk factors that would place the patient at risk of bleeding.
Beschrijving

Blood Coagulation Disorders Major | Risk factors Patient Bleeding risk

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C0030705
UMLS CUI [2,3]
C3251812
4. recent surgery (within 30 days).
Beschrijving

Recent surgery

Datatype

boolean

Alias
UMLS CUI [1]
C2169607
5. renal insufficiency, severe kidney disorders/diseases, gfr < 30mg/dl (gadolinium contraindication).
Beschrijving

Renal Insufficiency | Kidney Diseases Severe | Glomerular Filtration Rate | Medical contraindication Gadolinium

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0017654
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0016911
6. advanced liver disease.
Beschrijving

Liver disease Advanced

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205179
7. any health related gadolinium/mri contraindications: pacemaker devices, etc.
Beschrijving

Medical contraindication Gadolinium | Medical contraindication MRI | Artificial cardiac pacemaker

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0016911
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0024485
UMLS CUI [3]
C0030163
8. pregnant, planning to be become pregnant or nursing women
Beschrijving

Pregnancy | Pregnancy, Planned | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
9. individuals who are unable to provide informed consent
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
10. contraindicated for pradaxa® .
Beschrijving

Medical contraindication Pradaxa

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2940579
11. patients the investigators feel are inappropriate for the study
Beschrijving

Study Subject Participation Status Inappropriate

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
12. patients who cannot give informed consent
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
Terug naar het begin van de pagina

Similar models

Eligibility Atrial Fibrillation NCT01546883

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Atrial Fibrillation Type All | Exception Heart Valve Involvement | Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Permanent atrial fibrillation
Item
1. patients with all types of non-valvular af (includes paroxysmal, persistent and permanent af)
boolean
C0004238 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018826 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C0235480 (UMLS CUI [3])
C2585653 (UMLS CUI [4])
C2586056 (UMLS CUI [5])
Patient Appropriate Anticoagulation Therapy
Item
2. candidate for anticoagulation therapy
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0003281 (UMLS CUI [1,3])
Medical contraindication Absent Nuclear magnetic resonance imaging gadolinium-enhanced
Item
3. no contra-indication for lge-mri
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0855566 (UMLS CUI [1,3])
Age
Item
4. patients age 18 and older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
5. patients who are able to provide informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Catheter ablation for atrial fibrillation Previous
Item
1. patients who have already undergone an atrial fibrillation ablation procedure.
boolean
C2702800 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Medical contraindication Anticoagulants
Item
2. patients with active contra-indications to any anticoagulant agent.
boolean
C1301624 (UMLS CUI [1,1])
C0003280 (UMLS CUI [1,2])
Blood Coagulation Disorders Major | Risk factors Patient Bleeding risk
Item
3. other major bleeding disorders or risk factors that would place the patient at risk of bleeding.
boolean
C0005779 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C3251812 (UMLS CUI [2,3])
Recent surgery
Item
4. recent surgery (within 30 days).
boolean
C2169607 (UMLS CUI [1])
Renal Insufficiency | Kidney Diseases Severe | Glomerular Filtration Rate | Medical contraindication Gadolinium
Item
5. renal insufficiency, severe kidney disorders/diseases, gfr < 30mg/dl (gadolinium contraindication).
boolean
C1565489 (UMLS CUI [1])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0017654 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0016911 (UMLS CUI [4,2])
Liver disease Advanced
Item
6. advanced liver disease.
boolean
C0023895 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Medical contraindication Gadolinium | Medical contraindication MRI | Artificial cardiac pacemaker
Item
7. any health related gadolinium/mri contraindications: pacemaker devices, etc.
boolean
C1301624 (UMLS CUI [1,1])
C0016911 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C0030163 (UMLS CUI [3])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
8. pregnant, planning to be become pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Informed Consent Unable
Item
9. individuals who are unable to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Medical contraindication Pradaxa
Item
10. contraindicated for pradaxa® .
boolean
C1301624 (UMLS CUI [1,1])
C2940579 (UMLS CUI [1,2])
Study Subject Participation Status Inappropriate
Item
11. patients the investigators feel are inappropriate for the study
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
Informed Consent Unable
Item
12. patients who cannot give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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