ID

37499

Descrição

Atorvastatin Using as a Possible Prophylaxis of Postoperative Atrial Fibrillation After Cardiac Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT01570530

Link

https://clinicaltrials.gov/show/NCT01570530

Palavras-chave

Versões (1)
  1. 03/08/2019 03/08/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

3 de agosto de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01570530

Inglês

Eligibility Atrial Fibrillation NCT01570530

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men and women over 18 year-old.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
2. in sinus rhythm.
Descrição

Sinus rhythm

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232201
3. affected by valve disease, isolated or associated with coronary artery disease, satisfying requirements for heart surgery under extracorporeal circulation.
Descrição

Heart valve disease | Coronary Artery Disease | Requirement Cardiac Surgery Extracorporeal Circulation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018824
UMLS CUI [2]
C1956346
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0018821
UMLS CUI [3,3]
C0015354
4. women of childbearing potential must use effective contraception and they must commit to maintain it throughout the study.
Descrição

Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. urgent surgery.
Descrição

Urgent surgical procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2188405
2. surgery due to endocarditis.
Descrição

Operative Surgical Procedure Due to Endocarditis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0014118
3. patients with previous episodes of atrial fibrillation, although they are in sinus rhythm at hospital admission.
Descrição

Episode Previous Atrial Fibrillation | Sinus rhythm | Hospital admission

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0004238
UMLS CUI [2]
C0232201
UMLS CUI [3]
C0184666
4. treatment with beta-blockers at time of randomization
Descrição

Adrenergic beta-1 Receptor Antagonists

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0304516
5. severe left ventricular dysfunction with ventricular ejection fraction under 30%.
Descrição

Left Ventricular Dysfunction Severe | Left ventricular ejection fraction

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242698
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0428772
6. chronic using of nsaids and / or corticosteroids at time of randomization
Descrição

NSAIDs chronic | Adrenal Cortex Hormones chronic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0205191
7. uncontrolled thyroid disease.
Descrição

Thyroid Disease Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0205318
8. active liver disease and / or history of previous chronic liver disease.
Descrição

Liver disease | Chronic liver disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0341439
9. alcoholism.
Descrição

Alcoholic Intoxication, Chronic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001973
10. predisposing factors to statins adverse effects:
Descrição

Predisposing Factors | Adverse effects Statins

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032946
UMLS CUI [2,1]
C0879626
UMLS CUI [2,2]
C0360714
increased transaminase levels at baseline (x3 normal value).
Descrição

Transaminases increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0438717
renal failure (creatinine levels over 2 mg/dl).
Descrição

Kidney Failure | Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0201976
previous diagnosis of myopathy of any etiology.
Descrição

Myopathy Etiology Any

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0026848
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C1552551
11. known hypersensitivity to calcium atorvastatin and / or lactose monohydrate
Descrição

Hypersensitivity Atorvastatin calcium | Hypersensitivity Lactose Monohydrate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0286650
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1658042
12. in women of childbearing age, positive pregnancy test the day of inclusion in the study.
Descrição

Childbearing Potential Pregnancy test positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0240802
13. not signed informed consent.
Descrição

Informed Consent Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
14. inability to understand objectives of the study.
Descrição

Study Protocol Comprehension Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
exclusion criteria of the study once started:
Descrição

Exclusion Criteria | Clinical Trial Started

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C1272689
withdrawal of patient's consent.
Descrição

Withdrawal Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0021430
modification in liver laboratory parameters (transaminases above three times normal value) and / or creatine-fosfokinase level suggesting adverse effects of statins.
Descrição

Liver Laboratory parameters Modification | Transaminases increased | Creatine kinase measurement | Suggestive of Adverse effects Statins

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0449381
UMLS CUI [1,4]
C0392747
UMLS CUI [2]
C0438717
UMLS CUI [3]
C0201973
UMLS CUI [4,1]
C0332299
UMLS CUI [4,2]
C0879626
UMLS CUI [4,3]
C0360714
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Similar models

Eligibility Atrial Fibrillation NCT01570530

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. men and women over 18 year-old.
boolean
C0001779 (UMLS CUI [1])
Sinus rhythm
Item
2. in sinus rhythm.
boolean
C0232201 (UMLS CUI [1])
Heart valve disease | Coronary Artery Disease | Requirement Cardiac Surgery Extracorporeal Circulation
Item
3. affected by valve disease, isolated or associated with coronary artery disease, satisfying requirements for heart surgery under extracorporeal circulation.
boolean
C0018824 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0018821 (UMLS CUI [3,2])
C0015354 (UMLS CUI [3,3])
Childbearing Potential Contraceptive methods
Item
4. women of childbearing potential must use effective contraception and they must commit to maintain it throughout the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Urgent surgical procedure
Item
1. urgent surgery.
boolean
C2188405 (UMLS CUI [1])
Operative Surgical Procedure Due to Endocarditis
Item
2. surgery due to endocarditis.
boolean
C0543467 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0014118 (UMLS CUI [1,3])
Episode Previous Atrial Fibrillation | Sinus rhythm | Hospital admission
Item
3. patients with previous episodes of atrial fibrillation, although they are in sinus rhythm at hospital admission.
boolean
C0332189 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
C0232201 (UMLS CUI [2])
C0184666 (UMLS CUI [3])
Adrenergic beta-1 Receptor Antagonists
Item
4. treatment with beta-blockers at time of randomization
boolean
C0304516 (UMLS CUI [1])
Left Ventricular Dysfunction Severe | Left ventricular ejection fraction
Item
5. severe left ventricular dysfunction with ventricular ejection fraction under 30%.
boolean
C0242698 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2])
NSAIDs chronic | Adrenal Cortex Hormones chronic
Item
6. chronic using of nsaids and / or corticosteroids at time of randomization
boolean
C0003211 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Thyroid Disease Uncontrolled
Item
7. uncontrolled thyroid disease.
boolean
C0040128 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Liver disease | Chronic liver disease
Item
8. active liver disease and / or history of previous chronic liver disease.
boolean
C0023895 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
Alcoholic Intoxication, Chronic
Item
9. alcoholism.
boolean
C0001973 (UMLS CUI [1])
Predisposing Factors | Adverse effects Statins
Item
10. predisposing factors to statins adverse effects:
boolean
C0032946 (UMLS CUI [1])
C0879626 (UMLS CUI [2,1])
C0360714 (UMLS CUI [2,2])
Transaminases increased
Item
increased transaminase levels at baseline (x3 normal value).
boolean
C0438717 (UMLS CUI [1])
Kidney Failure | Creatinine measurement, serum
Item
renal failure (creatinine levels over 2 mg/dl).
boolean
C0035078 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Myopathy Etiology Any
Item
previous diagnosis of myopathy of any etiology.
boolean
C0026848 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Hypersensitivity Atorvastatin calcium | Hypersensitivity Lactose Monohydrate
Item
11. known hypersensitivity to calcium atorvastatin and / or lactose monohydrate
boolean
C0020517 (UMLS CUI [1,1])
C0286650 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1658042 (UMLS CUI [2,2])
Childbearing Potential Pregnancy test positive
Item
12. in women of childbearing age, positive pregnancy test the day of inclusion in the study.
boolean
C3831118 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
Informed Consent Lacking
Item
13. not signed informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Study Protocol Comprehension Unable
Item
14. inability to understand objectives of the study.
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Exclusion Criteria | Clinical Trial Started
Item
exclusion criteria of the study once started:
boolean
C0680251 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1272689 (UMLS CUI [2,2])
Withdrawal Informed Consent
Item
withdrawal of patient's consent.
boolean
C2349954 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Liver Laboratory parameters Modification | Transaminases increased | Creatine kinase measurement | Suggestive of Adverse effects Statins
Item
modification in liver laboratory parameters (transaminases above three times normal value) and / or creatine-fosfokinase level suggesting adverse effects of statins.
boolean
C0023884 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0449381 (UMLS CUI [1,3])
C0392747 (UMLS CUI [1,4])
C0438717 (UMLS CUI [2])
C0201973 (UMLS CUI [3])
C0332299 (UMLS CUI [4,1])
C0879626 (UMLS CUI [4,2])
C0360714 (UMLS CUI [4,3])
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