ID

37499

Beschrijving

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

Trefwoorden

Versies (1)
  1. 03-08-19 03-08-19 -
Houder van rechten

See clinicaltrials.gov

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3 augustus 2019

DOI

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Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01570530

Engels

Eligibility Atrial Fibrillation NCT01570530

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

boolean

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

Sinus rhythm

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Childbearing Potential Contraceptive methods

Datatype

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. urgent surgery.
Beschrijving

Urgent surgical procedure

Datatype

boolean

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

Operative Surgical Procedure Due to Endocarditis

Datatype

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.
Beschrijving

Episode Previous Atrial Fibrillation | Sinus rhythm | Hospital admission

Datatype

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
Beschrijving

Adrenergic beta-1 Receptor Antagonists

Datatype

boolean

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

Left Ventricular Dysfunction Severe | Left ventricular ejection fraction

Datatype

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
Beschrijving

NSAIDs chronic | Adrenal Cortex Hormones chronic

Datatype

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.
Beschrijving

Thyroid Disease Uncontrolled

Datatype

boolean

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

Liver disease | Chronic liver disease

Datatype

boolean

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

Alcoholic Intoxication, Chronic

Datatype

boolean

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

Predisposing Factors | Adverse effects Statins

Datatype

boolean

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

Transaminases increased

Datatype

boolean

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

Kidney Failure | Creatinine measurement, serum

Datatype

boolean

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

Myopathy Etiology Any

Datatype

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
Beschrijving

Hypersensitivity Atorvastatin calcium | Hypersensitivity Lactose Monohydrate

Datatype

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.
Beschrijving

Childbearing Potential Pregnancy test positive

Datatype

boolean

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

Informed Consent Lacking

Datatype

boolean

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

Study Protocol Comprehension Unable

Datatype

boolean

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

Exclusion Criteria | Clinical Trial Started

Datatype

boolean

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

Withdrawal Informed Consent

Datatype

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.
Beschrijving

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

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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