ID

37583

Descrição

The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01887353

Link

https://clinicaltrials.gov/show/NCT01887353

Palavras-chave

Versões (1)
  1. 08/08/2019 08/08/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

8 de agosto de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Atrial Fibrillation NCT01887353

Inglês

Eligibility Atrial Fibrillation NCT01887353

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or non-pregnant female > 18 years of age;
Descrição

Gender | Gender Pregnancy Absent | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0032961
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0001779
documentation of heart failure and who are in nyha class ii or iii;
Descrição

Heart failure New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
documented history of symptomatic af < 6 months in duration at the time of presentation, currently in af at the time of the external electrical cardioversion, and successfully restored to normal sinus rhythm;
Descrição

ATRIAL FIBRILLATION SYMPTOMATIC Duration | External elective cardioversion | Sinus rhythm Restore Successful

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0741283
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C2191347
UMLS CUI [3,1]
C0232201
UMLS CUI [3,2]
C1283255
UMLS CUI [3,3]
C1272703
percutaneous coronary intervention (pci) patients who can be placed on anticoagulation with warfarin post-cardioversion (and not on rivaroxaban or dabigatran);
Descrição

Percutaneous Coronary Intervention | Anticoagulation Therapy | Warfarin | Status post Electric Countershock

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2]
C0003281
UMLS CUI [3]
C0043031
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0013778
demonstration of preserved ejection fraction (ef) by echocardiography;
Descrição

Cardiac ejection fraction Echocardiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0013516
echocardiographic evidence of impaired diastolic filling.
Descrição

Filling period.diastole Impaired Echocardiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0806126
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0013516
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known history of permanent or long-standing af (> 6 months);
Descrição

Permanent atrial fibrillation Disease length | Atrial Fibrillation Long-term Disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2586056
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0443252
UMLS CUI [2,3]
C0872146
other acutely reversible causes of af, including but not limited to: hyperthyroidism, pericarditis, myocarditis or pulmonary embolism;
Descrição

Causes Reversible Atrial Fibrillation | Hyperthyroidism | Pericarditis | Myocarditis | Pulmonary Embolism

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205343
UMLS CUI [1,3]
C0004238
UMLS CUI [2]
C0020550
UMLS CUI [3]
C0031046
UMLS CUI [4]
C0027059
UMLS CUI [5]
C0034065
known history of cirrhosis;
Descrição

Liver Cirrhosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023890
nyha class iv;
Descrição

New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1275491
myocardial infarction, unstable angina, or coronary artery bypass graft surgery within three months prior to screening;
Descrição

Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0010055
percutaneous coronary intervention (pci) within 4 weeks prior to screening, if these patients need to be placed on rivaroxaban or dabigatran post-cardioversion;
Descrição

Percutaneous Coronary Intervention | Patient need for Rivaroxaban | Patient need for Dabigatran | Status post Electric Countershock

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C1739768
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C2348066
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0013778
clinically significant valvular disease;
Descrição

Valvular disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3258293
clinically significant pulmonary disease;
Descrição

Lung disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024115
stroke within 3 months prior to screening;
Descrição

Cerebrovascular accident

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038454
creatinine clearance < 30 ml/min as calculated by cockcroft-gault formula;
Descrição

Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2711451
use of anti-arrhythmic drugs (class ia or iiic) within 3 months prior to screening;
Descrição

Anti-Arrhythmia Agents Class

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C0456387
concurrent use of drugs considered strong inhibitors of cyp3a;
Descrição

CYP3A Inhibitors Strong

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3850056
UMLS CUI [1,2]
C0442821
concurrent use of drugs considered as cyp3a inducers;
Descrição

CYP3A Inducers

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3850044
prior treatment with ranolazine.
Descrição

ranolazine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0073633
Voltar ao início da página

Similar models

Eligibility Atrial Fibrillation NCT01887353

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Gender Pregnancy Absent | Age
Item
male or non-pregnant female > 18 years of age;
boolean
C0079399 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0001779 (UMLS CUI [3])
Heart failure New York Heart Association Classification
Item
documentation of heart failure and who are in nyha class ii or iii;
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
ATRIAL FIBRILLATION SYMPTOMATIC Duration | External elective cardioversion | Sinus rhythm Restore Successful
Item
documented history of symptomatic af < 6 months in duration at the time of presentation, currently in af at the time of the external electrical cardioversion, and successfully restored to normal sinus rhythm;
boolean
C0741283 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C2191347 (UMLS CUI [2])
C0232201 (UMLS CUI [3,1])
C1283255 (UMLS CUI [3,2])
C1272703 (UMLS CUI [3,3])
Percutaneous Coronary Intervention | Anticoagulation Therapy | Warfarin | Status post Electric Countershock
Item
percutaneous coronary intervention (pci) patients who can be placed on anticoagulation with warfarin post-cardioversion (and not on rivaroxaban or dabigatran);
boolean
C1532338 (UMLS CUI [1])
C0003281 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0013778 (UMLS CUI [4,2])
Cardiac ejection fraction Echocardiography
Item
demonstration of preserved ejection fraction (ef) by echocardiography;
boolean
C0232174 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Filling period.diastole Impaired Echocardiography
Item
echocardiographic evidence of impaired diastolic filling.
boolean
C0806126 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Permanent atrial fibrillation Disease length | Atrial Fibrillation Long-term Disease length
Item
known history of permanent or long-standing af (> 6 months);
boolean
C2586056 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
C0872146 (UMLS CUI [2,3])
Causes Reversible Atrial Fibrillation | Hyperthyroidism | Pericarditis | Myocarditis | Pulmonary Embolism
Item
other acutely reversible causes of af, including but not limited to: hyperthyroidism, pericarditis, myocarditis or pulmonary embolism;
boolean
C0015127 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
C0020550 (UMLS CUI [2])
C0031046 (UMLS CUI [3])
C0027059 (UMLS CUI [4])
C0034065 (UMLS CUI [5])
Liver Cirrhosis
Item
known history of cirrhosis;
boolean
C0023890 (UMLS CUI [1])
New York Heart Association Classification
Item
nyha class iv;
boolean
C1275491 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery
Item
myocardial infarction, unstable angina, or coronary artery bypass graft surgery within three months prior to screening;
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
Percutaneous Coronary Intervention | Patient need for Rivaroxaban | Patient need for Dabigatran | Status post Electric Countershock
Item
percutaneous coronary intervention (pci) within 4 weeks prior to screening, if these patients need to be placed on rivaroxaban or dabigatran post-cardioversion;
boolean
C1532338 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C1739768 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C2348066 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0013778 (UMLS CUI [4,2])
Valvular disease
Item
clinically significant valvular disease;
boolean
C3258293 (UMLS CUI [1])
Lung disease
Item
clinically significant pulmonary disease;
boolean
C0024115 (UMLS CUI [1])
Cerebrovascular accident
Item
stroke within 3 months prior to screening;
boolean
C0038454 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine clearance < 30 ml/min as calculated by cockcroft-gault formula;
boolean
C2711451 (UMLS CUI [1])
Anti-Arrhythmia Agents Class
Item
use of anti-arrhythmic drugs (class ia or iiic) within 3 months prior to screening;
boolean
C0003195 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
CYP3A Inhibitors Strong
Item
concurrent use of drugs considered strong inhibitors of cyp3a;
boolean
C3850056 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
CYP3A Inducers
Item
concurrent use of drugs considered as cyp3a inducers;
boolean
C3850044 (UMLS CUI [1])
ranolazine
Item
prior treatment with ranolazine.
boolean
C0073633 (UMLS CUI [1])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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