ID

15718

Beschreibung

Antithrombotic Strategy Variability In ATrial Fibrillation and Obstructive Coronary Disease Revascularized With PCI - The AVIATOR 2 Registry; ODM derived from: https://clinicaltrials.gov/show/NCT02362659

Link

https://clinicaltrials.gov/show/NCT02362659

Stichworte

Versionen (1)
  1. 09.06.16 09.06.16 -
Hochgeladen am

9. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non-valvular Atrial Fibrillation NCT02362659

Englisch

Eligibility Non-valvular Atrial Fibrillation NCT02362659

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of non-valvular atrial fibrillation during hospitalization.
Beschreibung

Atrial Fibrillation | Mitral Valve | Hospitalization

Datentyp

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0026264
UMLS CUI [3]
C0019993
preexisting atrial fibrillation.
Beschreibung

Atrial Fibrillation Pre-existing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C2347662
successful all-comer percutaneous coronary intervention:
Beschreibung

Percutaneous Coronary Intervention

Datentyp

boolean

Alias
UMLS CUI [1]
C1532338
procedural success is defined as a reduction of residual luminal diameter stenosis to <50% without in-hospital death, ami or the need for emergency cabg.
Beschreibung

Stenosis | Vessel lumen diameter reduction | Acute myocardial infarction | Emergency CABG

Datentyp

boolean

Alias
UMLS CUI [1]
C1261287
UMLS CUI [2]
C1443265
UMLS CUI [3]
C0155626
UMLS CUI [4]
C1532296
over 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
able to provide written informed consent
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
atrial fibrillation due to reversible causes (e.g., thyrotoxicosis, pericarditis)
Beschreibung

Atrial Fibrillation Due to Thyrotoxicosis | Atrial Fibrillation Due to Pericarditis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0040156
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0031046
valvular atrial fibrillation secondary to severe mitral stenosis or prosthetic heart valve
Beschreibung

Mitral Valve Atrial Fibrillation Secondary to Mitral Valve Stenosis Severe | Mitral Valve Atrial Fibrillation Secondary to Heart Valve Prosthesis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026264
UMLS CUI [1,2]
C0004238
UMLS CUI [1,3]
C0175668
UMLS CUI [1,4]
C0026269
UMLS CUI [1,5]
C0205082
UMLS CUI [2,1]
C0026264
UMLS CUI [2,2]
C0004238
UMLS CUI [2,3]
C0175668
UMLS CUI [2,4]
C0018825
women who are of childbearing potential treatment with other investigational drugs or devices within 30 days before enrolment or planned use of investigational drugs or devices during the study
Beschreibung

Childbearing Potential | Therapeutic procedure Investigational New Drugs Other | Therapeutic procedure Investigational Medical Device Other

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0205394
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C2346570
UMLS CUI [3,3]
C0205394
life expectancy <12 months due to non-cardiac comorbidities
Beschreibung

Life Expectancy Due to Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0009488
active alcohol, drug abuse, psychosocial reasons making study participation impractical
Beschreibung

Study Subject Participation Status Limited | Substance Use Disorders | psychosocial aspects

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0439801
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0243156
severe renal insufficiency (calculated creatinine clearance < 30 ml/min) or dialysis
Beschreibung

Renal Insufficiency Severe | Creatinine clearance measurement | Dialysis procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0373595
UMLS CUI [3]
C0011946
clinically overt stroke within the last 3 months
Beschreibung

Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
known hypersensitivity or contraindication to aspirin, clopidogrel, prasugrel, ticagrelor, dabigatran, rivaroxaban, apixaban, edoxaban or warfarin
Beschreibung

Hypersensitivity Aspirin | Medical contraindication Aspirin | Hypersensitivity clopidogrel | Medical contraindication clopidogrel | Hypersensitivity prasugrel | Medical contraindication prasugrel | Hypersensitivity Ticagrelor | Medical contraindication Ticagrelor | Hypersensitivity dabigatran | Medical contraindication dabigatran | Hypersensitivity rivaroxaban | Medical contraindication rivaroxaban | Hypersensitivity apixaban | Medical contraindication apixaban | Hypersensitivity edoxaban | Medical contraindication edoxaban | Hypersensitivity Warfarin | Medical contraindication Warfarin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0004057
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0070166
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0070166
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C1620287
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C1620287
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C1999375
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C1999375
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C2348066
UMLS CUI [10,1]
C1301624
UMLS CUI [10,2]
C2348066
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C1739768
UMLS CUI [12,1]
C1301624
UMLS CUI [12,2]
C1739768
UMLS CUI [13,1]
C0020517
UMLS CUI [13,2]
C1831808
UMLS CUI [14,1]
C1301624
UMLS CUI [14,2]
C1831808
UMLS CUI [15,1]
C0020517
UMLS CUI [15,2]
C2975435
UMLS CUI [16,1]
C1301624
UMLS CUI [16,2]
C2975435
UMLS CUI [17,1]
C0020517
UMLS CUI [17,2]
C0043031
UMLS CUI [18,1]
C1301624
UMLS CUI [18,2]
C0043031
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Ähnliche Modelle

Eligibility Non-valvular Atrial Fibrillation NCT02362659

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Atrial Fibrillation | Mitral Valve | Hospitalization
Item
diagnosis of non-valvular atrial fibrillation during hospitalization.
boolean
C0004238 (UMLS CUI [1])
C0026264 (UMLS CUI [2])
C0019993 (UMLS CUI [3])
Atrial Fibrillation Pre-existing
Item
preexisting atrial fibrillation.
boolean
C0004238 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Percutaneous Coronary Intervention
Item
successful all-comer percutaneous coronary intervention:
boolean
C1532338 (UMLS CUI [1])
Stenosis | Vessel lumen diameter reduction | Acute myocardial infarction | Emergency CABG
Item
procedural success is defined as a reduction of residual luminal diameter stenosis to <50% without in-hospital death, ami or the need for emergency cabg.
boolean
C1261287 (UMLS CUI [1])
C1443265 (UMLS CUI [2])
C0155626 (UMLS CUI [3])
C1532296 (UMLS CUI [4])
Age
Item
over 18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation Due to Thyrotoxicosis | Atrial Fibrillation Due to Pericarditis
Item
atrial fibrillation due to reversible causes (e.g., thyrotoxicosis, pericarditis)
boolean
C0004238 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0040156 (UMLS CUI [1,3])
C0004238 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0031046 (UMLS CUI [2,3])
Mitral Valve Atrial Fibrillation Secondary to Mitral Valve Stenosis Severe | Mitral Valve Atrial Fibrillation Secondary to Heart Valve Prosthesis
Item
valvular atrial fibrillation secondary to severe mitral stenosis or prosthetic heart valve
boolean
C0026264 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0175668 (UMLS CUI [1,3])
C0026269 (UMLS CUI [1,4])
C0205082 (UMLS CUI [1,5])
C0026264 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
C0175668 (UMLS CUI [2,3])
C0018825 (UMLS CUI [2,4])
Childbearing Potential | Therapeutic procedure Investigational New Drugs Other | Therapeutic procedure Investigational Medical Device Other
Item
women who are of childbearing potential treatment with other investigational drugs or devices within 30 days before enrolment or planned use of investigational drugs or devices during the study
boolean
C3831118 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C2346570 (UMLS CUI [3,2])
C0205394 (UMLS CUI [3,3])
Life Expectancy Due to Comorbidity
Item
life expectancy <12 months due to non-cardiac comorbidities
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Study Subject Participation Status Limited | Substance Use Disorders | psychosocial aspects
Item
active alcohol, drug abuse, psychosocial reasons making study participation impractical
boolean
C2348568 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2])
C0243156 (UMLS CUI [3])
Renal Insufficiency Severe | Creatinine clearance measurement | Dialysis procedure
Item
severe renal insufficiency (calculated creatinine clearance < 30 ml/min) or dialysis
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
Cerebrovascular accident
Item
clinically overt stroke within the last 3 months
boolean
C0038454 (UMLS CUI [1])
Hypersensitivity Aspirin | Medical contraindication Aspirin | Hypersensitivity clopidogrel | Medical contraindication clopidogrel | Hypersensitivity prasugrel | Medical contraindication prasugrel | Hypersensitivity Ticagrelor | Medical contraindication Ticagrelor | Hypersensitivity dabigatran | Medical contraindication dabigatran | Hypersensitivity rivaroxaban | Medical contraindication rivaroxaban | Hypersensitivity apixaban | Medical contraindication apixaban | Hypersensitivity edoxaban | Medical contraindication edoxaban | Hypersensitivity Warfarin | Medical contraindication Warfarin
Item
known hypersensitivity or contraindication to aspirin, clopidogrel, prasugrel, ticagrelor, dabigatran, rivaroxaban, apixaban, edoxaban or warfarin
boolean
C0020517 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0070166 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C1620287 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C1620287 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C1999375 (UMLS CUI [7,2])
C1301624 (UMLS CUI [8,1])
C1999375 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C2348066 (UMLS CUI [9,2])
C1301624 (UMLS CUI [10,1])
C2348066 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C1739768 (UMLS CUI [11,2])
C1301624 (UMLS CUI [12,1])
C1739768 (UMLS CUI [12,2])
C0020517 (UMLS CUI [13,1])
C1831808 (UMLS CUI [13,2])
C1301624 (UMLS CUI [14,1])
C1831808 (UMLS CUI [14,2])
C0020517 (UMLS CUI [15,1])
C2975435 (UMLS CUI [15,2])
C1301624 (UMLS CUI [16,1])
C2975435 (UMLS CUI [16,2])
C0020517 (UMLS CUI [17,1])
C0043031 (UMLS CUI [17,2])
C1301624 (UMLS CUI [18,1])
C0043031 (UMLS CUI [18,2])
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