ID

25777

Beschreibung

Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00446966

Link

https://clinicaltrials.gov/show/NCT00446966

Stichworte

Versionen (1)
  1. 19.09.17 19.09.17 -
Hochgeladen am

19. September 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00446966

Englisch

Eligibility Atrial Fibrillation NCT00446966

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-85 years old.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
elective coronary cabg operation with or without concomitant valve surgery planned for at least 2 days after enrollment.
Beschreibung

Coronary Artery Bypass Surgery elective | Heart Valve Operative Surgical Procedures Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C0439608
UMLS CUI [2,1]
C0018826
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C1301732
signed, documented informed consent prior to admission to the study.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
urgent or emergent bypass required to be performed <24 hrs after screening.
Beschreibung

Bypass Urgent Patient need for | Bypass Emergency Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0741847
UMLS CUI [1,2]
C0439609
UMLS CUI [1,3]
C0686904
UMLS CUI [2,1]
C0741847
UMLS CUI [2,2]
C0013956
UMLS CUI [2,3]
C0686904
unstable angina, requiring intervention or cabg <24 hrs after screening.
Beschreibung

Unstable Angina Requirement Intervention | Unstable Angina Requirement Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002965
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0184661
UMLS CUI [2,1]
C0002965
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0010055
decompensated congestive heart failure.
Beschreibung

CONGESTIVE HEART FAILURE DECOMPENSATED

Datentyp

boolean

Alias
UMLS CUI [1]
C0742746
chronic, persistent atrial fibrillation - patient in atrial fibrillation at the time of screening or enrollment or scheduled for a maze procedure or pulmonary vein isolation at the time of surgery.
Beschreibung

Persistent atrial fibrillation chronic | Maze Procedure Scheduled | Pulmonary vein isolation Scheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2585653
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C3272262
UMLS CUI [2,2]
C0205539
UMLS CUI [3,1]
C3544330
UMLS CUI [3,2]
C0205539
known sensitivity to omacor (0mega-3 acid ethyl esters) and hypersensitivity to fish, fish products or corn oil.
Beschreibung

Hypersensitivity Lovaza | Hypersensitivity Omega-3 Acid Ethyl Esters | Allergy to fish | Hypersensitivity Fish Products | Hypersensitivity Corn Oil

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0912903
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1532673
UMLS CUI [3]
C0856904
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0016158
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0010029
patients requiring warfarin or lovenox the 2 days prior to bypass surgery.
Beschreibung

Warfarin Patient need for | Lovenox Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0043031
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C0728963
UMLS CUI [2,2]
C0686904
patients on class i or iii antiarrhythmic agents (quinidine, procainamide, disopyramide, flecainide, propafenone, moricizine, dofetilide, sotalol, amiodarone) or who have taken these drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone).
Beschreibung

Anti-Arrhythmia Agents Class | Quinidine | Procainamide | Disopyramide | Flecainide | Propafenone | Moricizine | dofetilide | Sotalol | Amiodarone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C0456387
UMLS CUI [2]
C0034414
UMLS CUI [3]
C0033216
UMLS CUI [4]
C0012702
UMLS CUI [5]
C0016229
UMLS CUI [6]
C0033429
UMLS CUI [7]
C0079856
UMLS CUI [8]
C0114771
UMLS CUI [9]
C0037707
UMLS CUI [10]
C0002598
patients who are pregnant or nursing.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients unable to provide/sign informed consent.
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
patients currently enrolled in another clinical trial without a 30 day washout period.
Beschreibung

Study Subject Participation Status | Washout Period Lacking

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1710661
UMLS CUI [2,2]
C0332268
patients currently taking marine based omega-three fish oil supplements.
Beschreibung

Omega-3 Fish Oil Supplement Marine-based

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015689
UMLS CUI [1,2]
C0016157
UMLS CUI [1,3]
C2348609
UMLS CUI [1,4]
C3829196
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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT00446966

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-85 years old.
boolean
C0001779 (UMLS CUI [1])
Coronary Artery Bypass Surgery elective | Heart Valve Operative Surgical Procedures Planned
Item
elective coronary cabg operation with or without concomitant valve surgery planned for at least 2 days after enrollment.
boolean
C0010055 (UMLS CUI [1,1])
C0439608 (UMLS CUI [1,2])
C0018826 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Informed Consent
Item
signed, documented informed consent prior to admission to the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Bypass Urgent Patient need for | Bypass Emergency Patient need for
Item
urgent or emergent bypass required to be performed <24 hrs after screening.
boolean
C0741847 (UMLS CUI [1,1])
C0439609 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0741847 (UMLS CUI [2,1])
C0013956 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
Unstable Angina Requirement Intervention | Unstable Angina Requirement Coronary Artery Bypass Surgery
Item
unstable angina, requiring intervention or cabg <24 hrs after screening.
boolean
C0002965 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C0002965 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0010055 (UMLS CUI [2,3])
CONGESTIVE HEART FAILURE DECOMPENSATED
Item
decompensated congestive heart failure.
boolean
C0742746 (UMLS CUI [1])
Persistent atrial fibrillation chronic | Maze Procedure Scheduled | Pulmonary vein isolation Scheduled
Item
chronic, persistent atrial fibrillation - patient in atrial fibrillation at the time of screening or enrollment or scheduled for a maze procedure or pulmonary vein isolation at the time of surgery.
boolean
C2585653 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C3272262 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
C3544330 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
Hypersensitivity Lovaza | Hypersensitivity Omega-3 Acid Ethyl Esters | Allergy to fish | Hypersensitivity Fish Products | Hypersensitivity Corn Oil
Item
known sensitivity to omacor (0mega-3 acid ethyl esters) and hypersensitivity to fish, fish products or corn oil.
boolean
C0020517 (UMLS CUI [1,1])
C0912903 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1532673 (UMLS CUI [2,2])
C0856904 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0016158 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0010029 (UMLS CUI [5,2])
Warfarin Patient need for | Lovenox Patient need for
Item
patients requiring warfarin or lovenox the 2 days prior to bypass surgery.
boolean
C0043031 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0728963 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Anti-Arrhythmia Agents Class | Quinidine | Procainamide | Disopyramide | Flecainide | Propafenone | Moricizine | dofetilide | Sotalol | Amiodarone
Item
patients on class i or iii antiarrhythmic agents (quinidine, procainamide, disopyramide, flecainide, propafenone, moricizine, dofetilide, sotalol, amiodarone) or who have taken these drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone).
boolean
C0003195 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0034414 (UMLS CUI [2])
C0033216 (UMLS CUI [3])
C0012702 (UMLS CUI [4])
C0016229 (UMLS CUI [5])
C0033429 (UMLS CUI [6])
C0079856 (UMLS CUI [7])
C0114771 (UMLS CUI [8])
C0037707 (UMLS CUI [9])
C0002598 (UMLS CUI [10])
Pregnancy | Breast Feeding
Item
patients who are pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Informed Consent Unable
Item
patients unable to provide/sign informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Study Subject Participation Status | Washout Period Lacking
Item
patients currently enrolled in another clinical trial without a 30 day washout period.
boolean
C2348568 (UMLS CUI [1])
C1710661 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Omega-3 Fish Oil Supplement Marine-based
Item
patients currently taking marine based omega-three fish oil supplements.
boolean
C0015689 (UMLS CUI [1,1])
C0016157 (UMLS CUI [1,2])
C2348609 (UMLS CUI [1,3])
C3829196 (UMLS CUI [1,4])
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