ID

35605

Descripción

A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-eluting Stent Implantation; ODM derived from: https://clinicaltrials.gov/show/NCT02513810

Link

https://clinicaltrials.gov/show/NCT02513810

Palabras clave

Versiones (1)
  1. 11/3/19 11/3/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

11 de marzo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02513810

Inglés

Eligibility Coronary Artery Disease NCT02513810

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients ≥ 19 years old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
patients with ischemic heart disease who are considered for coronary revascularization with pci
Descripción

Myocardial Ischemia | Coronary revascularisation considered | Percutaneous Coronary Intervention considered

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2,1]
C0877341
UMLS CUI [2,2]
C0750591
UMLS CUI [3,1]
C1532338
UMLS CUI [3,2]
C0750591
significant coronary de novo lesion
Descripción

Lesion Coronary de novo

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522318
UMLS CUI [1,3]
C1515568
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute coronary syndrome
Descripción

Acute Coronary Syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948089
complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesion
Descripción

Lesion morphological complex | Lesion Aorta Ostium | Lesion Left coronary artery main stem | Chronic total occlusion of coronary artery | Lesion Graft | Thrombosis | Lesion Calcified Very Angiogram | Lesion Tortuous Extremely

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0543482
UMLS CUI [1,3]
C0439855
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0003483
UMLS CUI [2,3]
C0444567
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0226031
UMLS CUI [4]
C1955779
UMLS CUI [5,1]
C0221198
UMLS CUI [5,2]
C0332835
UMLS CUI [6]
C0040053
UMLS CUI [7,1]
C0221198
UMLS CUI [7,2]
C0175895
UMLS CUI [7,3]
C0442824
UMLS CUI [7,4]
C0002978
UMLS CUI [8,1]
C0221198
UMLS CUI [8,2]
C4068863
UMLS CUI [8,3]
C0205403
need of use of anticoagulant or dual antiplatelet therapy more than 1 month because of other medical conditions
Descripción

Patient need for Anticoagulant therapy | Patient need for Antiplatelet therapy Dual | Etiology Other medical condition

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0150457
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C1096021
UMLS CUI [2,3]
C0205173
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C3843040
serum creatinine >2.0 mg/dl or esrd
Descripción

Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
cardiogenic shock or experience of cardiopulmonary resuscitation
Descripción

Shock, Cardiogenic | Cardiopulmonary Resuscitation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036980
UMLS CUI [2]
C0007203
contraindication or hypersensitivity to biolimus a9, stainless steel, heparin, antiplatelet agents or contrast media
Descripción

Medical contraindication Biolimus A9 | Hypersensitivity Biolimus A9 | Medical contraindication Stainless Steel | Hypersensitivity Stainless Steel | Medical contraindication Heparin | Heparin allergy | Medical contraindication Antiplatelet Agents | Hypersensitivity Antiplatelet Agents | Medical contraindication Contrast Media | Contrast media allergy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C4310325
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C4310325
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0038126
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0038126
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0019134
UMLS CUI [6]
C0571776
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0085826
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0085826
UMLS CUI [9,1]
C1301624
UMLS CUI [9,2]
C0009924
UMLS CUI [10]
C0570562
history of documented prior cerebrovascular attack within 6 months
Descripción

Cerebrovascular accident

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038454
treated with any stent within 3 months
Descripción

Stenting

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348535
reference vessel diameter <2.25 mm or >4.0 mm
Descripción

Reference Vessel Diameter

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1706462
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C1301886
pregnant women or women with potential childbearing
Descripción

Pregnancy | Childbearing Potential

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
Descripción

Follow-up Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1299582
inability to understand or read the informed content
Descripción

Informed Consent Unable

Tipo de datos

boolean

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

Eligibility Coronary Artery Disease NCT02513810

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients ≥ 19 years old
boolean
C0001779 (UMLS CUI [1])
Myocardial Ischemia | Coronary revascularisation considered | Percutaneous Coronary Intervention considered
Item
patients with ischemic heart disease who are considered for coronary revascularization with pci
boolean
C0151744 (UMLS CUI [1])
C0877341 (UMLS CUI [2,1])
C0750591 (UMLS CUI [2,2])
C1532338 (UMLS CUI [3,1])
C0750591 (UMLS CUI [3,2])
Lesion Coronary de novo
Item
significant coronary de novo lesion
boolean
C0221198 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
C1515568 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Acute Coronary Syndrome
Item
acute coronary syndrome
boolean
C0948089 (UMLS CUI [1])
Lesion morphological complex | Lesion Aorta Ostium | Lesion Left coronary artery main stem | Chronic total occlusion of coronary artery | Lesion Graft | Thrombosis | Lesion Calcified Very Angiogram | Lesion Tortuous Extremely
Item
complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesion
boolean
C0221198 (UMLS CUI [1,1])
C0543482 (UMLS CUI [1,2])
C0439855 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0003483 (UMLS CUI [2,2])
C0444567 (UMLS CUI [2,3])
C0221198 (UMLS CUI [3,1])
C0226031 (UMLS CUI [3,2])
C1955779 (UMLS CUI [4])
C0221198 (UMLS CUI [5,1])
C0332835 (UMLS CUI [5,2])
C0040053 (UMLS CUI [6])
C0221198 (UMLS CUI [7,1])
C0175895 (UMLS CUI [7,2])
C0442824 (UMLS CUI [7,3])
C0002978 (UMLS CUI [7,4])
C0221198 (UMLS CUI [8,1])
C4068863 (UMLS CUI [8,2])
C0205403 (UMLS CUI [8,3])
Patient need for Anticoagulant therapy | Patient need for Antiplatelet therapy Dual | Etiology Other medical condition
Item
need of use of anticoagulant or dual antiplatelet therapy more than 1 month because of other medical conditions
boolean
C0686904 (UMLS CUI [1,1])
C0150457 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C1096021 (UMLS CUI [2,2])
C0205173 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C3843040 (UMLS CUI [3,2])
Creatinine measurement, serum
Item
serum creatinine >2.0 mg/dl or esrd
boolean
C0201976 (UMLS CUI [1])
Shock, Cardiogenic | Cardiopulmonary Resuscitation
Item
cardiogenic shock or experience of cardiopulmonary resuscitation
boolean
C0036980 (UMLS CUI [1])
C0007203 (UMLS CUI [2])
Medical contraindication Biolimus A9 | Hypersensitivity Biolimus A9 | Medical contraindication Stainless Steel | Hypersensitivity Stainless Steel | Medical contraindication Heparin | Heparin allergy | Medical contraindication Antiplatelet Agents | Hypersensitivity Antiplatelet Agents | Medical contraindication Contrast Media | Contrast media allergy
Item
contraindication or hypersensitivity to biolimus a9, stainless steel, heparin, antiplatelet agents or contrast media
boolean
C1301624 (UMLS CUI [1,1])
C4310325 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C4310325 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0038126 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0038126 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C0019134 (UMLS CUI [5,2])
C0571776 (UMLS CUI [6])
C1301624 (UMLS CUI [7,1])
C0085826 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0085826 (UMLS CUI [8,2])
C1301624 (UMLS CUI [9,1])
C0009924 (UMLS CUI [9,2])
C0570562 (UMLS CUI [10])
Cerebrovascular accident
Item
history of documented prior cerebrovascular attack within 6 months
boolean
C0038454 (UMLS CUI [1])
Stenting
Item
treated with any stent within 3 months
boolean
C2348535 (UMLS CUI [1])
Reference Vessel Diameter
Item
reference vessel diameter <2.25 mm or >4.0 mm
boolean
C1706462 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Pregnancy | Childbearing Potential
Item
pregnant women or women with potential childbearing
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
Follow-up Unable
Item
inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
boolean
C3274571 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Informed Consent Unable
Item
inability to understand or read the informed content
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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