ID

36809

Beschrijving

Study of Statin for Reduction of Postoperative Paroxysmal Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT02502110

Link

https://clinicaltrials.gov/show/NCT02502110

Trefwoorden

Versies (1)
  1. 11-06-19 11-06-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 juni 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Paroxysmal Atrial Fibrillation NCT02502110

Engels

Eligibility Paroxysmal Atrial Fibrillation NCT02502110

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of informed consent prior to any study specific procedures;
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
2. age from 18 to 75 years old, male or female;
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. the course of paroxysmal af is more than 3 months and confirmed by ecg;
Beschrijving

Paroxysmal atrial fibrillation Duration Electrocardiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0235480
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C1623258
4. plan to undergo radiofrequency catheter ablation
Beschrijving

Radiofrequency Catheter Ablation Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162561
UMLS CUI [1,2]
C1301732
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. concomitant with serious organic heart disease such as valvular heart diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardial infarction and unstable angina pectoris;
Beschrijving

Organic heart disease Serious | Heart valve disease | Congenital heart disease | Hypertrophic Cardiomyopathy | Myocardial Infarction | Angina, Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0747057
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0018824
UMLS CUI [3]
C0152021
UMLS CUI [4]
C0007194
UMLS CUI [5]
C0027051
UMLS CUI [6]
C0002965
2. concomitant with sinoatrial node functional disorder and (or) atrioventricular block;
Beschrijving

Sinus Node Dysfunction | Atrioventricular Block

Datatype

boolean

Alias
UMLS CUI [1]
C0428908
UMLS CUI [2]
C0004245
3. acute cerebral apoplexy or contraindication of anticoagulant;
Beschrijving

Cerebrovascular accident | Medical contraindication Anticoagulants

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0003280
4. thyroid function abnormality;
Beschrijving

Abnormal thyroid function

Datatype

boolean

Alias
UMLS CUI [1]
C0857576
5. accepted radiofrequency catheter ablation (rfca) previously;
Beschrijving

Radiofrequency Catheter Ablation Accepted Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162561
UMLS CUI [1,2]
C1272684
UMLS CUI [1,3]
C0205156
6. being receiving other statins;
Beschrijving

Statins

Datatype

boolean

Alias
UMLS CUI [1]
C0360714
7. be allergic to statins;
Beschrijving

Hypersensitivity Statins

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0360714
8. pregnancy or women during lactation period;
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
9. be not aligning to treatment or follow-up due to mental disorders or other reasons;
Beschrijving

Treatment Compliance Lacking | Follow-up Adherence Lacking | Etiology Mental disorders

Datatype

boolean

Alias
UMLS CUI [1,1]
C4319828
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C1510802
UMLS CUI [2,3]
C0332268
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0004936
10. be with myopathy or active hepatopathy including agnogenic persistent elevation of serum transaminase and any serum transaminase being over 3 times of upper limit of normal;
Beschrijving

Myopathy | Liver disease | Serum transaminase increased Persistent agnogenic | Serum transaminase increased Any

Datatype

boolean

Alias
UMLS CUI [1]
C0026848
UMLS CUI [2]
C0023895
UMLS CUI [3,1]
C0859350
UMLS CUI [3,2]
C0205322
UMLS CUI [3,3]
C0332240
UMLS CUI [4,1]
C0859350
UMLS CUI [4,2]
C1552551
11. be with serious renal dysfunction (creatinine≥3 mg/dl);
Beschrijving

Renal dysfunction Serious | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0201976
12. need steroid or non-steroid anti-inflammatory drugs to treat inflammation.
Beschrijving

Steroidal anti-inflammatory drugs Inflammation | Non-Steroidal Anti-Inflammatory Agents Inflammation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003212
UMLS CUI [1,2]
C0021368
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0021368
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Similar models

Eligibility Paroxysmal Atrial Fibrillation NCT02502110

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. provision of informed consent prior to any study specific procedures;
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age from 18 to 75 years old, male or female;
boolean
C0001779 (UMLS CUI [1])
Paroxysmal atrial fibrillation Duration Electrocardiography
Item
3. the course of paroxysmal af is more than 3 months and confirmed by ecg;
boolean
C0235480 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1623258 (UMLS CUI [1,3])
Radiofrequency Catheter Ablation Planned
Item
4. plan to undergo radiofrequency catheter ablation
boolean
C0162561 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Organic heart disease Serious | Heart valve disease | Congenital heart disease | Hypertrophic Cardiomyopathy | Myocardial Infarction | Angina, Unstable
Item
1. concomitant with serious organic heart disease such as valvular heart diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardial infarction and unstable angina pectoris;
boolean
C0747057 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018824 (UMLS CUI [2])
C0152021 (UMLS CUI [3])
C0007194 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
Sinus Node Dysfunction | Atrioventricular Block
Item
2. concomitant with sinoatrial node functional disorder and (or) atrioventricular block;
boolean
C0428908 (UMLS CUI [1])
C0004245 (UMLS CUI [2])
Cerebrovascular accident | Medical contraindication Anticoagulants
Item
3. acute cerebral apoplexy or contraindication of anticoagulant;
boolean
C0038454 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0003280 (UMLS CUI [2,2])
Abnormal thyroid function
Item
4. thyroid function abnormality;
boolean
C0857576 (UMLS CUI [1])
Radiofrequency Catheter Ablation Accepted Previous
Item
5. accepted radiofrequency catheter ablation (rfca) previously;
boolean
C0162561 (UMLS CUI [1,1])
C1272684 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Statins
Item
6. being receiving other statins;
boolean
C0360714 (UMLS CUI [1])
Hypersensitivity Statins
Item
7. be allergic to statins;
boolean
C0020517 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
8. pregnancy or women during lactation period;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Treatment Compliance Lacking | Follow-up Adherence Lacking | Etiology Mental disorders
Item
9. be not aligning to treatment or follow-up due to mental disorders or other reasons;
boolean
C4319828 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C1510802 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0004936 (UMLS CUI [3,2])
Myopathy | Liver disease | Serum transaminase increased Persistent agnogenic | Serum transaminase increased Any
Item
10. be with myopathy or active hepatopathy including agnogenic persistent elevation of serum transaminase and any serum transaminase being over 3 times of upper limit of normal;
boolean
C0026848 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0859350 (UMLS CUI [3,1])
C0205322 (UMLS CUI [3,2])
C0332240 (UMLS CUI [3,3])
C0859350 (UMLS CUI [4,1])
C1552551 (UMLS CUI [4,2])
Renal dysfunction Serious | Creatinine measurement, serum
Item
11. be with serious renal dysfunction (creatinine≥3 mg/dl);
boolean
C3279454 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
Steroidal anti-inflammatory drugs Inflammation | Non-Steroidal Anti-Inflammatory Agents Inflammation
Item
12. need steroid or non-steroid anti-inflammatory drugs to treat inflammation.
boolean
C0003212 (UMLS CUI [1,1])
C0021368 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2,1])
C0021368 (UMLS CUI [2,2])
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