ID

37465

Descrição

Phase 2 Study of Oral K201 for Prevention of AF Recurrence; ODM derived from: https://clinicaltrials.gov/show/NCT01067833

Link

https://clinicaltrials.gov/show/NCT01067833

Palavras-chave

Versões (1)
  1. 30/07/2019 30/07/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

30 de julho 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 NCT01067833

Inglês

Eligibility Atrial Fibrillation NCT01067833

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
symptomatic af (sustained >3 days and <6 months) and clinically indicated for cardioversion;
Descrição

ATRIAL FIBRILLATION SYMPTOMATIC Duration | Indication Electric Countershock

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0741283
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0013778
adequate anticoagulant therapy for cardioversion in accordance with standard practice as recommended by acc/aha/esc guidelines or with local clinical practice;
Descrição

Anticoagulant therapy Electric Countershock

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0150457
UMLS CUI [1,2]
C0013778
hemodynamically stable (90 mmhg < systolic blood pressure < 190 mmhg)at screening and on day 1;
Descrição

Stable status Hemodynamic | Systolic Pressure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0019010
UMLS CUI [2]
C0871470
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known prolonged qt syndrome or qtc interval of >0.500 sec at screening; familial long qt syndrome; previous torsade de pointes; ventricular fibrillation; or sustained ventricular tachycardia (vt);
Descrição

Long QT Syndrome | QTc interval | Family history of long QT syndrome | Torsades de Pointes | Ventricular Fibrillation | Sustained ventricular tachycardia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023976
UMLS CUI [2]
C0489625
UMLS CUI [3]
C3839836
UMLS CUI [4]
C0040479
UMLS CUI [5]
C0042510
UMLS CUI [6]
C0750197
qrs >0.130 sec;
Descrição

QRS duration

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0429025
previous episodes of second- or third-degree atrioventricular block;
Descrição

Episode of Second degree atrioventricular block | Episode of Complete atrioventricular block

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0264906
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0151517
unsuccessful dc cardioversion attempt within 3 months; prior ablation for af;
Descrição

Direct current cardioversion Attempt Unsuccessful | Catheter ablation for atrial fibrillation Previous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0542380
UMLS CUI [1,2]
C1516084
UMLS CUI [1,3]
C1272705
UMLS CUI [2,1]
C2702800
UMLS CUI [2,2]
C0205156
persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker (including crt, aicd);
Descrição

Bradycardia Persistent | Ventricular Heart Rate | Sick Sinus Syndrome | Artificial cardiac pacemaker | Cardiac Resynchronization Therapy Device | Automatic Implantable Cardioverter-Defibrillators

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0428977
UMLS CUI [1,2]
C0205322
UMLS CUI [2]
C1883530
UMLS CUI [3]
C0037052
UMLS CUI [4]
C0030163
UMLS CUI [5]
C2936377
UMLS CUI [6]
C0972395
myocardial infarction (mi), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study;
Descrição

Myocardial Infarction | Cardiac Surgery | Angioplasty | Angina, Unstable | Acute Coronary Syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0018821
UMLS CUI [3]
C0162577
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0948089
nyha class iii or class iv heart failure (hf) at screening or admission, or hospitalized for hf in previous 6 months;
Descrição

Heart failure New York Heart Association Classification | Hospitalization Due to Heart Failure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C3898876
known concurrent temporary secondary causes of af;
Descrição

Cause Temporary Secondary Atrial Fibrillation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205374
UMLS CUI [1,3]
C0175668
UMLS CUI [1,4]
C0004238
received a class i or class iii antiarrhythmic agent (including sotalol) within 5 half-lives of randomization or amiodarone or dronedarone within 4 weeks;
Descrição

Anti-Arrhythmia Agents Class | Sotalol | Amiodarone | dronedarone

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C0456387
UMLS CUI [2]
C0037707
UMLS CUI [3]
C0002598
UMLS CUI [4]
C0766326
received treatment with other drugs known to prolong the qt interval within 5 half-lives.
Descrição

Pharmaceutical Preparations Causing Prolonged QT interval

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
Voltar ao início da página

Similar models

Eligibility Atrial Fibrillation NCT01067833

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
ATRIAL FIBRILLATION SYMPTOMATIC Duration | Indication Electric Countershock
Item
symptomatic af (sustained >3 days and <6 months) and clinically indicated for cardioversion;
boolean
C0741283 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0013778 (UMLS CUI [2,2])
Anticoagulant therapy Electric Countershock
Item
adequate anticoagulant therapy for cardioversion in accordance with standard practice as recommended by acc/aha/esc guidelines or with local clinical practice;
boolean
C0150457 (UMLS CUI [1,1])
C0013778 (UMLS CUI [1,2])
Stable status Hemodynamic | Systolic Pressure
Item
hemodynamically stable (90 mmhg < systolic blood pressure < 190 mmhg)at screening and on day 1;
boolean
C0205360 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Long QT Syndrome | QTc interval | Family history of long QT syndrome | Torsades de Pointes | Ventricular Fibrillation | Sustained ventricular tachycardia
Item
known prolonged qt syndrome or qtc interval of >0.500 sec at screening; familial long qt syndrome; previous torsade de pointes; ventricular fibrillation; or sustained ventricular tachycardia (vt);
boolean
C0023976 (UMLS CUI [1])
C0489625 (UMLS CUI [2])
C3839836 (UMLS CUI [3])
C0040479 (UMLS CUI [4])
C0042510 (UMLS CUI [5])
C0750197 (UMLS CUI [6])
QRS duration
Item
qrs >0.130 sec;
boolean
C0429025 (UMLS CUI [1])
Episode of Second degree atrioventricular block | Episode of Complete atrioventricular block
Item
previous episodes of second- or third-degree atrioventricular block;
boolean
C0332189 (UMLS CUI [1,1])
C0264906 (UMLS CUI [1,2])
C0332189 (UMLS CUI [2,1])
C0151517 (UMLS CUI [2,2])
Direct current cardioversion Attempt Unsuccessful | Catheter ablation for atrial fibrillation Previous
Item
unsuccessful dc cardioversion attempt within 3 months; prior ablation for af;
boolean
C0542380 (UMLS CUI [1,1])
C1516084 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C2702800 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Bradycardia Persistent | Ventricular Heart Rate | Sick Sinus Syndrome | Artificial cardiac pacemaker | Cardiac Resynchronization Therapy Device | Automatic Implantable Cardioverter-Defibrillators
Item
persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker (including crt, aicd);
boolean
C0428977 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C1883530 (UMLS CUI [2])
C0037052 (UMLS CUI [3])
C0030163 (UMLS CUI [4])
C2936377 (UMLS CUI [5])
C0972395 (UMLS CUI [6])
Myocardial Infarction | Cardiac Surgery | Angioplasty | Angina, Unstable | Acute Coronary Syndrome
Item
myocardial infarction (mi), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study;
boolean
C0027051 (UMLS CUI [1])
C0018821 (UMLS CUI [2])
C0162577 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0948089 (UMLS CUI [5])
Heart failure New York Heart Association Classification | Hospitalization Due to Heart Failure
Item
nyha class iii or class iv heart failure (hf) at screening or admission, or hospitalized for hf in previous 6 months;
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C3898876 (UMLS CUI [2])
Cause Temporary Secondary Atrial Fibrillation
Item
known concurrent temporary secondary causes of af;
boolean
C0015127 (UMLS CUI [1,1])
C0205374 (UMLS CUI [1,2])
C0175668 (UMLS CUI [1,3])
C0004238 (UMLS CUI [1,4])
Anti-Arrhythmia Agents Class | Sotalol | Amiodarone | dronedarone
Item
received a class i or class iii antiarrhythmic agent (including sotalol) within 5 half-lives of randomization or amiodarone or dronedarone within 4 weeks;
boolean
C0003195 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0037707 (UMLS CUI [2])
C0002598 (UMLS CUI [3])
C0766326 (UMLS CUI [4])
Pharmaceutical Preparations Causing Prolonged QT interval
Item
received treatment with other drugs known to prolong the qt interval within 5 half-lives.
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
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