ID

37605

Description

Cardiac Surgery and the Risk of Atrial Fibrillation: an Intervention Trial Evaluating Melatonin; ODM derived from: https://clinicaltrials.gov/show/NCT02099331

Link

https://clinicaltrials.gov/show/NCT02099331

Keywords

Versions (1)
  1. 8/11/19 8/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02099331

English

Eligibility Atrial Fibrillation NCT02099331

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age over the age of 18.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. scheduled for elective cardiac surgery (coronary artery bypass grafting, valvular surgery or combined procedures)
Description

Cardiac Surgery elective Scheduled | Coronary Artery Bypass Surgery | Valve Surgery | Procedure Combined

Data type

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C0439608
UMLS CUI [1,3]
C0205539
UMLS CUI [2]
C0010055
UMLS CUI [3,1]
C1186983
UMLS CUI [3,2]
C0543467
UMLS CUI [4,1]
C0184661
UMLS CUI [4,2]
C0205195
3. enroll at least 48 hours before surgery is scheduled
Description

Enrollment | Status pre- Patient scheduled for surgery

Data type

boolean

Alias
UMLS CUI [1]
C1516879
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C3242215
4. presence of normal sinus rhythm on screening electrocardiogram.
Description

Electrocardiogram: normal sinus rhythm

Data type

boolean

Alias
UMLS CUI [1]
C1960147
5. be willing to provide informed consent (which may be provided by a legally authorized representative if the patient is not able to do so).
Description

Informed Consent | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of prior atrial fibrillation
Description

Atrial Fibrillation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0205156
2. inability to give informed consent.
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
3. use of anti-arrhythmic drugs other than beta-blockers
Description

Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists

Data type

boolean

Alias
UMLS CUI [1]
C0003195
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0304516
4. chronic nsaid or antioxidant use
Description

NSAIDs chronic | Antioxidants chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0003402
UMLS CUI [2,2]
C0205191
5. history of severe autoimmune disorders with the need for autoimmune medications.
Description

Autoimmune Diseases Severe | Patient need for Pharmaceutical Preparations Autoimmune Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0004364
6. history of epilepsy.
Description

Epilepsy

Data type

boolean

Alias
UMLS CUI [1]
C0014544
7. compromised hepatic function (aminotransferase levels > 1.5 times the upper limit of normal)
Description

Liver Dysfunction | Transaminases increased

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0438717
8. current pregnancy (determined by either serum or urine pregnancy test, as ordered by the primary team)
Description

Pregnancy Serum pregnancy test positive | Pregnancy Urine pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0430063
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0430059
9. non-english speakers
Description

Lacking Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
10. current use of warfarin, nifedipine, fluvoxamine.
Description

Warfarin | Nifedipine | Fluvoxamine

Data type

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0028066
UMLS CUI [3]
C0085228
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Similar models

Eligibility Atrial Fibrillation NCT02099331

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age over the age of 18.
boolean
C0001779 (UMLS CUI [1])
Cardiac Surgery elective Scheduled | Coronary Artery Bypass Surgery | Valve Surgery | Procedure Combined
Item
2. scheduled for elective cardiac surgery (coronary artery bypass grafting, valvular surgery or combined procedures)
boolean
C0018821 (UMLS CUI [1,1])
C0439608 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0010055 (UMLS CUI [2])
C1186983 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0184661 (UMLS CUI [4,1])
C0205195 (UMLS CUI [4,2])
Enrollment | Status pre- Patient scheduled for surgery
Item
3. enroll at least 48 hours before surgery is scheduled
boolean
C1516879 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C3242215 (UMLS CUI [2,2])
Electrocardiogram: normal sinus rhythm
Item
4. presence of normal sinus rhythm on screening electrocardiogram.
boolean
C1960147 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representative
Item
5. be willing to provide informed consent (which may be provided by a legally authorized representative if the patient is not able to do so).
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation Previous
Item
1. history of prior atrial fibrillation
boolean
C0004238 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Informed Consent Unable
Item
2. inability to give informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists
Item
3. use of anti-arrhythmic drugs other than beta-blockers
boolean
C0003195 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0304516 (UMLS CUI [2,2])
NSAIDs chronic | Antioxidants chronic
Item
4. chronic nsaid or antioxidant use
boolean
C0003211 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0003402 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Autoimmune Diseases Severe | Patient need for Pharmaceutical Preparations Autoimmune Diseases
Item
5. history of severe autoimmune disorders with the need for autoimmune medications.
boolean
C0004364 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0004364 (UMLS CUI [2,3])
Epilepsy
Item
6. history of epilepsy.
boolean
C0014544 (UMLS CUI [1])
Liver Dysfunction | Transaminases increased
Item
7. compromised hepatic function (aminotransferase levels > 1.5 times the upper limit of normal)
boolean
C0086565 (UMLS CUI [1])
C0438717 (UMLS CUI [2])
Pregnancy Serum pregnancy test positive | Pregnancy Urine pregnancy test positive
Item
8. current pregnancy (determined by either serum or urine pregnancy test, as ordered by the primary team)
boolean
C0032961 (UMLS CUI [1,1])
C0430063 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2,1])
C0430059 (UMLS CUI [2,2])
Lacking Able to speak English Language
Item
9. non-english speakers
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
Warfarin | Nifedipine | Fluvoxamine
Item
10. current use of warfarin, nifedipine, fluvoxamine.
boolean
C0043031 (UMLS CUI [1])
C0028066 (UMLS CUI [2])
C0085228 (UMLS CUI [3])
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