ID

36809

Description

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

Link

https://clinicaltrials.gov/show/NCT02502110

Keywords

Versions (1)
  1. 6/11/19 6/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Paroxysmal Atrial Fibrillation NCT02502110

English

Eligibility Paroxysmal Atrial Fibrillation NCT02502110

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Informed Consent

Data type

boolean

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

Age

Data type

boolean

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

Paroxysmal atrial fibrillation Duration Electrocardiography

Data type

boolean

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

Radiofrequency Catheter Ablation Planned

Data type

boolean

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

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;
Description

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

Data type

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;
Description

Sinus Node Dysfunction | Atrioventricular Block

Data type

boolean

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

Cerebrovascular accident | Medical contraindication Anticoagulants

Data type

boolean

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

Abnormal thyroid function

Data type

boolean

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

Radiofrequency Catheter Ablation Accepted Previous

Data type

boolean

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

Statins

Data type

boolean

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

Hypersensitivity Statins

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

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;
Description

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

Data type

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;
Description

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

Data type

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);
Description

Renal dysfunction Serious | Creatinine measurement, serum

Data type

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.
Description

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

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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