ID

37496

Description

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

Keywords

Versions (1)
  1. 8/2/19 8/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 2, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01546883

English

Eligibility Atrial Fibrillation NCT01546883

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

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

Data type

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
Description

Patient Appropriate Anticoagulation Therapy

Data type

boolean

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

Medical contraindication Absent Nuclear magnetic resonance imaging gadolinium-enhanced

Data type

boolean

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

Age

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Catheter ablation for atrial fibrillation Previous

Data type

boolean

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

Medical contraindication Anticoagulants

Data type

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.
Description

Blood Coagulation Disorders Major | Risk factors Patient Bleeding risk

Data type

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).
Description

Recent surgery

Data type

boolean

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

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

Data type

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.
Description

Liver disease Advanced

Data type

boolean

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

Medical contraindication Gadolinium | Medical contraindication MRI | Artificial cardiac pacemaker

Data type

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
Description

Pregnancy | Pregnancy, Planned | Breast Feeding

Data type

boolean

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

Informed Consent Unable

Data type

boolean

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

Medical contraindication Pradaxa

Data type

boolean

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

Study Subject Participation Status Inappropriate

Data type

boolean

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

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Atrial Fibrillation NCT01546883

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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