ID

36809

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02502110

Nyckelord

Versioner (1)
  1. 2019-06-11 2019-06-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 juni 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Paroxysmal Atrial Fibrillation NCT02502110

Engelsk

Eligibility Paroxysmal Atrial Fibrillation NCT02502110

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Informed Consent

Datatyp

boolean

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

Age

Datatyp

boolean

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

Paroxysmal atrial fibrillation Duration Electrocardiography

Datatyp

boolean

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

Radiofrequency Catheter Ablation Planned

Datatyp

boolean

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

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;
Beskrivning

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

Datatyp

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;
Beskrivning

Sinus Node Dysfunction | Atrioventricular Block

Datatyp

boolean

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

Cerebrovascular accident | Medical contraindication Anticoagulants

Datatyp

boolean

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

Abnormal thyroid function

Datatyp

boolean

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

Radiofrequency Catheter Ablation Accepted Previous

Datatyp

boolean

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

Statins

Datatyp

boolean

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

Hypersensitivity Statins

Datatyp

boolean

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

Pregnancy | Breast Feeding

Datatyp

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;
Beskrivning

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

Datatyp

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;
Beskrivning

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

Datatyp

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);
Beskrivning

Renal dysfunction Serious | Creatinine measurement, serum

Datatyp

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.
Beskrivning

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

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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