Informações:
Falhas:
ID
16266
Descrição
Intra-Cardiac Echocardiography Guided Cardioversion(ICE-CHIP) Study; ODM derived from: https://clinicaltrials.gov/show/NCT00281073
Link
https://clinicaltrials.gov/show/NCT00281073
Palavras-chave
Versões (1)
- 08/07/2016 08/07/2016 -
Transferido a
8 de julho de 2016
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.
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 NCT00281073
Eligibility Atrial Fibrillation NCT00281073
- StudyEvent: Eligibility
Similar models
Eligibility Atrial Fibrillation NCT00281073
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
inclusion criteria
Item
inclusion criteria for the phase i component
boolean
C1512693 (UMLS CUI [1])
spontaneous af
Item
1. patients with spontaneous af
boolean
C0235480 (UMLS CUI [1])
structural heart disease
Item
2. patients with or without structural heart disease.
boolean
C1290384 (UMLS CUI [1])
Age
Item
3. men or women aged 18 years or older.
boolean
C0001779 (UMLS CUI [1])
invasive catheterization procedure
Item
4. patients undergoing an invasive catheterization procedure including right heart catheterization.
boolean
C0018795 (UMLS CUI [1])
informed consent
Item
5. patients who give an informed consent for participation in the study.
boolean
C0021430 (UMLS CUI [1])
intracardiac thrombi
Item
6. patients who have undergone a trans-thoracic echocardiogram within the last 14 days showing absence of intracardiac thrombi.
boolean
C0876998 (UMLS CUI [1])
trans-esophageal echocardiogram
Item
7. patients who have undergone a trans-esophageal echocardiogram within the last 48 hours.
boolean
C0206054 (UMLS CUI [1])
inclusion criteria
Item
inclusion criteria for the phase ii component
boolean
C1512693 (UMLS CUI [1])
spontaneous af
Item
1. patients with spontaneous af
boolean
C0235480 (UMLS CUI [1])
structural heart disease
Item
2. patients with or without structural heart disease.
boolean
C1290384 (UMLS CUI [1])
Age
Item
3. men or women aged 18 years or older.
boolean
C0001779 (UMLS CUI [1])
invasive catheterization procedure
Item
4. patients undergoing an invasive catheterization procedure including right heart catheterization.
boolean
C0018795 (UMLS CUI [1])
informed consent
Item
5. patients who give an informed consent for participation in the study.
boolean
C0021430 (UMLS CUI [1])
intracardiac thrombi
Item
6. patients who have undergone a trans-thoracic echocardiogram within the last 14 days showing absence of intracardiac thrombi.
boolean
C0876998 (UMLS CUI [1])
exclusion criteria
Item
exclusion criteria for the phase ii component
boolean
C0680251 (UMLS CUI [1])
Anticoagulation
Item
1. patients anticoagulated for > 7 days.
boolean
C0449867 (UMLS CUI [1])
cardioembolic event
Item
2. patients who have had a cardioembolic event within the last 1-month.
boolean
C1531624 (UMLS CUI [1])
cardioversion due to hemodynamic instability
Item
3. patients requiring urgent cardioversion due to hemodynamic instability.
boolean
C0013778 (UMLS CUI [1])
C0948268 (UMLS CUI [2])
C0948268 (UMLS CUI [2])
Technical feasibility
Item
4. patients in whom placement of an ice catheter for adequate atrial visualization is technically not feasible.
boolean
contraindications for warfarin
Item
5. patients with contraindications for warfarin.
boolean
C1278473 (UMLS CUI [1])
women of child bearing potential
Item
6. women of child bearing potential, in whom pregnancy cannot be excluded.
text
C0425965 (UMLS CUI [1])
anticoagulation
Item
7. patients who need anticoagulation withdrawn due to an elective procedure
text
C0449867 (UMLS CUI [1])
medical condition or social circumstance
Item
8. patients with any medical condition or social circumstance, which in the opinion of the investigator would make the patient's successful completion of the study doubtful.
text
C0009488 (UMLS CUI [1])
C0037431 (UMLS CUI [2])
C0037431 (UMLS CUI [2])
exclusion criteria
Item
exclusion criteria for the phase i component
boolean
C0680251 (UMLS CUI [1])
Technical feasibility
Item
1. patients in whom placement of an ice catheter for adequate atrial visualization is technically not feasible.
boolean
women of child bearing potential
Item
2. women of child bearing potential, in whom pregnancy cannot be excluded.
boolean
C0425965 (UMLS CUI [1])
medical condition or social circumstance
Item
3. patients with any medical condition or social circumstance, which in the opinion of the investigator, would make the patient's successful completion of the study doubtful
boolean
C0009488 (UMLS CUI [1])
C0037431 (UMLS CUI [2])
C0037431 (UMLS CUI [2])