ID

37500

Beschreibung

Statin Therapy In Cardiac Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT01573143

Link

https://clinicaltrials.gov/show/NCT01573143

Stichworte

Versionen (1)
  1. 03.08.19 03.08.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

3. August 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01573143

Englisch

Eligibility Atrial Fibrillation NCT01573143

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients awaiting elective cardiac surgery who are willing and able to give informed consent for participation in the study and who are in sinus rhythm and not taking any antiarrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery.
Beschreibung

Adult | Cardiac Surgery elective Expected | Informed Consent | Sinus rhythm | Anti-Arrhythmia Agents Absent | Exception Adrenergic beta-Antagonists

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C0018821
UMLS CUI [2,2]
C0439608
UMLS CUI [2,3]
C1517001
UMLS CUI [3]
C0021430
UMLS CUI [4]
C0232201
UMLS CUI [5,1]
C0003195
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0001645
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of obstructive hepato-biliary disease or other serious hepatic disease
Beschreibung

Hepatobiliary disease Obstructive | Liver disease Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0267792
UMLS CUI [1,2]
C0549186
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205404
untreated hypothyroidism
Beschreibung

Hypothyroidism Untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020676
UMLS CUI [1,2]
C0332155
creatinine > 200 umol/l
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
personal and family history of hereditary muscle disorders
Beschreibung

Hereditary muscle disorders | Family history Hereditary muscle disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0852407
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C0852407
known intolerance to statins or history of muscle toxicity with fibrates or statins.
Beschreibung

Intolerance to Statins | Muscle Toxicity Fibrates | Muscle Toxicity Statins

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0360714
UMLS CUI [2,1]
C0026845
UMLS CUI [2,2]
C0600688
UMLS CUI [2,3]
C1449704
UMLS CUI [3,1]
C0026845
UMLS CUI [3,2]
C0600688
UMLS CUI [3,3]
C0360714
on-going use of fibrates, niacin or of agents that are strong inhibitors of cytochrome p-450 or the p-glycoprotein within a month preceding randomization (cyclosporine, oral azole antifungals,macrolide antibiotics, protease inhibitors, nefazodone, amiodarone or ≥ 1l/day of grapefruit juice)
Beschreibung

Fibrates | Niacin | Cytochrome P450 Inhibitors Strong | P-Glycoprotein Inhibitors Strong | Cyclosporine | Azole antifungal Oral | Macrolide Antibiotics | Protease Inhibitors | nefazodone | Amiodarone | GRAPEFRUIT JUICE L/day

Datentyp

boolean

Alias
UMLS CUI [1]
C1449704
UMLS CUI [2]
C0027996
UMLS CUI [3,1]
C2962191
UMLS CUI [3,2]
C0442821
UMLS CUI [4,1]
C3500483
UMLS CUI [4,2]
C0442821
UMLS CUI [5]
C0010592
UMLS CUI [6,1]
C0360363
UMLS CUI [6,2]
C1527415
UMLS CUI [7]
C0003240
UMLS CUI [8]
C0033607
UMLS CUI [9]
C0068485
UMLS CUI [10]
C0002598
UMLS CUI [11,1]
C0452456
UMLS CUI [11,2]
C0475219
significant mitral valve disease (moderate or severe mitral regurgitation-eg. > grade ii and/or mitral stenosis & mitral annular calcification).
Beschreibung

Diseases of mitral valve | Mitral Valve Insufficiency Moderate Grade | Mitral Valve Insufficiency Severe Grade | Mitral Valve Stenosis | Mitral valve annular calcification

Datentyp

boolean

Alias
UMLS CUI [1]
C0026265
UMLS CUI [2,1]
C0026266
UMLS CUI [2,2]
C0205081
UMLS CUI [2,3]
C0441800
UMLS CUI [3,1]
C0026266
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0441800
UMLS CUI [4]
C0026269
UMLS CUI [5]
C0428811
patients treated with any anti-arrhythmic agent (other than beta-adrenergic receptor blockers).
Beschreibung

Anti-Arrhythmia Agents | Exception Adrenergic beta-Antagonists

Datentyp

boolean

Alias
UMLS CUI [1]
C0003195
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0001645
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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT01573143

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Cardiac Surgery elective Expected | Informed Consent | Sinus rhythm | Anti-Arrhythmia Agents Absent | Exception Adrenergic beta-Antagonists
Item
adult patients awaiting elective cardiac surgery who are willing and able to give informed consent for participation in the study and who are in sinus rhythm and not taking any antiarrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery.
boolean
C0001675 (UMLS CUI [1])
C0018821 (UMLS CUI [2,1])
C0439608 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3])
C0232201 (UMLS CUI [4])
C0003195 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0001645 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Hepatobiliary disease Obstructive | Liver disease Serious
Item
history of obstructive hepato-biliary disease or other serious hepatic disease
boolean
C0267792 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Hypothyroidism Untreated
Item
untreated hypothyroidism
boolean
C0020676 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Creatinine measurement, serum
Item
creatinine > 200 umol/l
boolean
C0201976 (UMLS CUI [1])
Hereditary muscle disorders | Family history Hereditary muscle disorders
Item
personal and family history of hereditary muscle disorders
boolean
C0852407 (UMLS CUI [1])
C0241889 (UMLS CUI [2,1])
C0852407 (UMLS CUI [2,2])
Intolerance to Statins | Muscle Toxicity Fibrates | Muscle Toxicity Statins
Item
known intolerance to statins or history of muscle toxicity with fibrates or statins.
boolean
C1744706 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
C0026845 (UMLS CUI [2,1])
C0600688 (UMLS CUI [2,2])
C1449704 (UMLS CUI [2,3])
C0026845 (UMLS CUI [3,1])
C0600688 (UMLS CUI [3,2])
C0360714 (UMLS CUI [3,3])
Fibrates | Niacin | Cytochrome P450 Inhibitors Strong | P-Glycoprotein Inhibitors Strong | Cyclosporine | Azole antifungal Oral | Macrolide Antibiotics | Protease Inhibitors | nefazodone | Amiodarone | GRAPEFRUIT JUICE L/day
Item
on-going use of fibrates, niacin or of agents that are strong inhibitors of cytochrome p-450 or the p-glycoprotein within a month preceding randomization (cyclosporine, oral azole antifungals,macrolide antibiotics, protease inhibitors, nefazodone, amiodarone or ≥ 1l/day of grapefruit juice)
boolean
C1449704 (UMLS CUI [1])
C0027996 (UMLS CUI [2])
C2962191 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
C3500483 (UMLS CUI [4,1])
C0442821 (UMLS CUI [4,2])
C0010592 (UMLS CUI [5])
C0360363 (UMLS CUI [6,1])
C1527415 (UMLS CUI [6,2])
C0003240 (UMLS CUI [7])
C0033607 (UMLS CUI [8])
C0068485 (UMLS CUI [9])
C0002598 (UMLS CUI [10])
C0452456 (UMLS CUI [11,1])
C0475219 (UMLS CUI [11,2])
Diseases of mitral valve | Mitral Valve Insufficiency Moderate Grade | Mitral Valve Insufficiency Severe Grade | Mitral Valve Stenosis | Mitral valve annular calcification
Item
significant mitral valve disease (moderate or severe mitral regurgitation-eg. > grade ii and/or mitral stenosis & mitral annular calcification).
boolean
C0026265 (UMLS CUI [1])
C0026266 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0441800 (UMLS CUI [2,3])
C0026266 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0441800 (UMLS CUI [3,3])
C0026269 (UMLS CUI [4])
C0428811 (UMLS CUI [5])
Anti-Arrhythmia Agents | Exception Adrenergic beta-Antagonists
Item
patients treated with any anti-arrhythmic agent (other than beta-adrenergic receptor blockers).
boolean
C0003195 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0001645 (UMLS CUI [2,2])
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