ID

37639

Description

Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT01590979

Link

https://clinicaltrials.gov/show/NCT01590979

Keywords

Versions (1)
  1. 8/12/19 8/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation New Onset NCT01590979

English

Eligibility Atrial Fibrillation New Onset NCT01590979

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female candidates (18 years of age and older) undergoing coronary bypass grafting surgery or valve repair or replacement - aortic or tricuspid or pulmonary valves
Description

Age | Coronary Artery Bypass Surgery | Valvuloplasty of aortic valve | Replacement of aortic valve | Repair of tricuspid valve | Replacement of tricuspid valve | Repair of pulmonary valve | Replacement of pulmonary valve

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0010055
UMLS CUI [3]
C0396949
UMLS CUI [4]
C0003506
UMLS CUI [5]
C0396899
UMLS CUI [6]
C0190119
UMLS CUI [7]
C0190127
UMLS CUI [8]
C0190129
patients who are not previously on ranolazine
Description

Ranolazine Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0073633
UMLS CUI [1,2]
C0332197
do not have a history of arrhythmia and are not on any antiarrhythmic therapy
Description

Cardiac Arrhythmia Absent | Anti-Arrhythmia Agents Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0003195
UMLS CUI [2,2]
C0332197
patients with qtc on a 12 lead ekg of less than or equal to 460 ms
Description

QTc 12 lead ECG

Data type

boolean

Alias
UMLS CUI [1,1]
C0860814
UMLS CUI [1,2]
C0430456
patients with estimated glomerular filtration rate (gfr) greater than 30 ml/min/1.73 m2 on the initial lab work
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
available at least 48 hours before surgery
Description

Patient Available Before Operative Surgical Procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0543467
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are not undergoing above surgeries
Description

Inclusion criteria Surgeries Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0332197
patients undergoing surgery for mitral valve replacement/repair
Description

Replacement of mitral valve | Mitral valvuloplasty

Data type

boolean

Alias
UMLS CUI [1]
C0026268
UMLS CUI [2]
C0396849
patient with cirrhosis
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
pregnant patients
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
patients with chronic atrial fibrillation
Description

Chronic atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0694539
patients who had prior adverse drug reactions or allergies to ranolazine
Description

Adverse reaction to Ranolazine | Hypersensitivity Ranolazine

Data type

boolean

Alias
UMLS CUI [1,1]
C0041755
UMLS CUI [1,2]
C0073633
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0073633
patients who are already taking ranolazine prior to the study
Description

Ranolazine Intake Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0073633
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C2347662
patient who are reported hiv positive (as there are antiretroviral drug interactions)
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
patients who are on drugs listed in appendix a prior to the study
Description

Pharmaceutical Preparations Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205369
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Similar models

Eligibility Atrial Fibrillation New Onset NCT01590979

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Coronary Artery Bypass Surgery | Valvuloplasty of aortic valve | Replacement of aortic valve | Repair of tricuspid valve | Replacement of tricuspid valve | Repair of pulmonary valve | Replacement of pulmonary valve
Item
male and female candidates (18 years of age and older) undergoing coronary bypass grafting surgery or valve repair or replacement - aortic or tricuspid or pulmonary valves
boolean
C0001779 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C0396949 (UMLS CUI [3])
C0003506 (UMLS CUI [4])
C0396899 (UMLS CUI [5])
C0190119 (UMLS CUI [6])
C0190127 (UMLS CUI [7])
C0190129 (UMLS CUI [8])
Ranolazine Absent
Item
patients who are not previously on ranolazine
boolean
C0073633 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Cardiac Arrhythmia Absent | Anti-Arrhythmia Agents Absent
Item
do not have a history of arrhythmia and are not on any antiarrhythmic therapy
boolean
C0003811 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0003195 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
QTc 12 lead ECG
Item
patients with qtc on a 12 lead ekg of less than or equal to 460 ms
boolean
C0860814 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Estimated Glomerular Filtration Rate
Item
patients with estimated glomerular filtration rate (gfr) greater than 30 ml/min/1.73 m2 on the initial lab work
boolean
C3811844 (UMLS CUI [1])
Patient Available Before Operative Surgical Procedure
Item
available at least 48 hours before surgery
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Inclusion criteria Surgeries Absent
Item
patients who are not undergoing above surgeries
boolean
C1512693 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Replacement of mitral valve | Mitral valvuloplasty
Item
patients undergoing surgery for mitral valve replacement/repair
boolean
C0026268 (UMLS CUI [1])
C0396849 (UMLS CUI [2])
Liver Cirrhosis
Item
patient with cirrhosis
boolean
C0023890 (UMLS CUI [1])
Pregnancy
Item
pregnant patients
boolean
C0032961 (UMLS CUI [1])
Chronic atrial fibrillation
Item
patients with chronic atrial fibrillation
boolean
C0694539 (UMLS CUI [1])
Adverse reaction to Ranolazine | Hypersensitivity Ranolazine
Item
patients who had prior adverse drug reactions or allergies to ranolazine
boolean
C0041755 (UMLS CUI [1,1])
C0073633 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0073633 (UMLS CUI [2,2])
Ranolazine Intake Pre-existing
Item
patients who are already taking ranolazine prior to the study
boolean
C0073633 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
HIV Seropositivity
Item
patient who are reported hiv positive (as there are antiretroviral drug interactions)
boolean
C0019699 (UMLS CUI [1])
Pharmaceutical Preparations Specified
Item
patients who are on drugs listed in appendix a prior to the study
boolean
C0013227 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
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