ID

37499

Description

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

Lien

https://clinicaltrials.gov/show/NCT01570530

Mots-clés

Versions (1)
  1. 03/08/2019 03/08/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

3 août 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01570530

Anglais

Eligibility Atrial Fibrillation NCT01570530

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Type de données

boolean

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

Sinus rhythm

Type de données

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.
Description

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

Type de données

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.
Description

Childbearing Potential Contraceptive methods

Type de données

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. urgent surgery.
Description

Urgent surgical procedure

Type de données

boolean

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

Operative Surgical Procedure Due to Endocarditis

Type de données

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.
Description

Episode Previous Atrial Fibrillation | Sinus rhythm | Hospital admission

Type de données

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
Description

Adrenergic beta-1 Receptor Antagonists

Type de données

boolean

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

Left Ventricular Dysfunction Severe | Left ventricular ejection fraction

Type de données

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
Description

NSAIDs chronic | Adrenal Cortex Hormones chronic

Type de données

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.
Description

Thyroid Disease Uncontrolled

Type de données

boolean

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

Liver disease | Chronic liver disease

Type de données

boolean

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

Alcoholic Intoxication, Chronic

Type de données

boolean

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

Predisposing Factors | Adverse effects Statins

Type de données

boolean

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

Transaminases increased

Type de données

boolean

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

Kidney Failure | Creatinine measurement, serum

Type de données

boolean

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

Myopathy Etiology Any

Type de données

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
Description

Hypersensitivity Atorvastatin calcium | Hypersensitivity Lactose Monohydrate

Type de données

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.
Description

Childbearing Potential Pregnancy test positive

Type de données

boolean

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

Informed Consent Lacking

Type de données

boolean

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

Study Protocol Comprehension Unable

Type de données

boolean

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

Exclusion Criteria | Clinical Trial Started

Type de données

boolean

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

Withdrawal Informed Consent

Type de données

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.
Description

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

Type de données

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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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