ID

39056

Descrição

Statin Therapy In Atrial Refractoriness and Reperfusion Injury; ODM derived from: https://clinicaltrials.gov/show/NCT01780740

Link

https://clinicaltrials.gov/show/NCT01780740

Palavras-chave

Versões (1)
  1. 26/11/2019 26/11/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

26 de novembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Disorder; Heart, Functional, Postoperative, Cardiac Surgery NCT01780740

Inglês

Eligibility Disorder; Heart, Functional, Postoperative, Cardiac Surgery NCT01780740

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant is willing and able to give informed consent for participation in the study.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
male or female, aged 18 years or above.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
requiring elective cardiac surgery.
Descrição

Requirement Cardiac Surgery elective

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0018821
UMLS CUI [1,3]
C0439608
able (in the investigators' opinion) and willing to comply with all study requirements.
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study.
Descrição

Study Subject Participation Status Willing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
age>85yrs
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
female participant who is pregnant, lactating or planning pregnancy during the course of the study.
Descrição

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
women of child-bearing potential without appropriate contraceptive measures. these include oral contraceptive pills, intrauterine contraceptive devices etc
Descrição

Childbearing Potential Contraceptive methods Absent | Contraceptives, Oral | Intrauterine Devices

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0009905
UMLS CUI [3]
C0021900
history of obstructive hepatobiliary disease or other serious hepatic disease or pre-operative alt >2-fold the upper limit of normal or alcohol abuse
Descrição

Hepatobiliary disease Obstructive | Liver disease Serious | Alanine aminotransferase increased Preoperative | Alcohol abuse

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0267792
UMLS CUI [1,2]
C0549186
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0151905
UMLS CUI [3,2]
C0445204
UMLS CUI [4]
C0085762
creatinine >200 umol/l
Descrição

Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
untreated hypothyroidism
Descrição

Hypothyroidism Untreated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020676
UMLS CUI [1,2]
C0332155
family history of hereditary muscle disorders
Descrição

Family history Hereditary muscle disorders

Tipo de dados

boolean

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

Intolerance to Statins | Muscle Toxicity | Fibrates | Statins

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0360714
UMLS CUI [2,1]
C0026845
UMLS CUI [2,2]
C0600688
UMLS CUI [3]
C1449704
UMLS CUI [4]
C0360714
ongoing 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, azole antifungals, such as itraconazole and ketoconazole, macrolide antibiotics, such as erythromycin and clarithromycin, protease inhibitors, nefazodone, verapamil, amiodarone or large quantity of grapefruit juice (≥ 1l/day) patients on treatment with anti arrhythmic agents, other than beta-adrenergic receptor blockers.
Descrição

Fibrates | Niacin | Cytochrome P-450 Enzyme Inhibitors Strong | P-Glycoprotein Inhibitors Strong | Cyclosporine | Azole antifungal | Itraconazole | Ketoconazole | Macrolide Antibiotics | Erythromycin | Clarithromycin | Protease Inhibitors | nefazodone | Verapamil | Amiodarone | GRAPEFRUIT JUICE Large amount | Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1449704
UMLS CUI [2]
C0027996
UMLS CUI [3,1]
C3850070
UMLS CUI [3,2]
C0442821
UMLS CUI [4,1]
C3500483
UMLS CUI [4,2]
C0442821
UMLS CUI [5]
C0010592
UMLS CUI [6]
C0360363
UMLS CUI [7]
C0064113
UMLS CUI [8]
C0022625
UMLS CUI [9]
C0003240
UMLS CUI [10]
C0014806
UMLS CUI [11]
C0055856
UMLS CUI [12]
C0033607
UMLS CUI [13]
C0068485
UMLS CUI [14]
C0042523
UMLS CUI [15]
C0002598
UMLS CUI [16,1]
C0452456
UMLS CUI [16,2]
C3869890
UMLS CUI [17]
C0003195
UMLS CUI [18,1]
C1705847
UMLS CUI [18,2]
C0304516
participant who is terminally ill or is inappropriate for placebo medication.
Descrição

Terminal illness | Patient Inappropriate Placebo

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0679247
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C1696465
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Similar models

Eligibility Disorder; Heart, Functional, Postoperative, Cardiac Surgery NCT01780740

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
participant is willing and able to give informed consent for participation in the study.
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female, aged 18 years or above.
boolean
C0001779 (UMLS CUI [1])
Requirement Cardiac Surgery elective
Item
requiring elective cardiac surgery.
boolean
C1514873 (UMLS CUI [1,1])
C0018821 (UMLS CUI [1,2])
C0439608 (UMLS CUI [1,3])
Protocol Compliance
Item
able (in the investigators' opinion) and willing to comply with all study requirements.
boolean
C0525058 (UMLS CUI [1])
Study Subject Participation Status Willing
Item
willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study.
boolean
C2348568 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
age>85yrs
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
female participant who is pregnant, lactating or planning pregnancy during the course of the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Childbearing Potential Contraceptive methods Absent | Contraceptives, Oral | Intrauterine Devices
Item
women of child-bearing potential without appropriate contraceptive measures. these include oral contraceptive pills, intrauterine contraceptive devices etc
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0009905 (UMLS CUI [2])
C0021900 (UMLS CUI [3])
Hepatobiliary disease Obstructive | Liver disease Serious | Alanine aminotransferase increased Preoperative | Alcohol abuse
Item
history of obstructive hepatobiliary disease or other serious hepatic disease or pre-operative alt >2-fold the upper limit of normal or alcohol abuse
boolean
C0267792 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0151905 (UMLS CUI [3,1])
C0445204 (UMLS CUI [3,2])
C0085762 (UMLS CUI [4])
Creatinine measurement, serum
Item
creatinine >200 umol/l
boolean
C0201976 (UMLS CUI [1])
Hypothyroidism Untreated
Item
untreated hypothyroidism
boolean
C0020676 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Family history Hereditary muscle disorders
Item
family history of hereditary muscle disorders
boolean
C0241889 (UMLS CUI [1,1])
C0852407 (UMLS CUI [1,2])
Intolerance to Statins | Muscle Toxicity | Fibrates | 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 [3])
C0360714 (UMLS CUI [4])
Fibrates | Niacin | Cytochrome P-450 Enzyme Inhibitors Strong | P-Glycoprotein Inhibitors Strong | Cyclosporine | Azole antifungal | Itraconazole | Ketoconazole | Macrolide Antibiotics | Erythromycin | Clarithromycin | Protease Inhibitors | nefazodone | Verapamil | Amiodarone | GRAPEFRUIT JUICE Large amount | Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists
Item
ongoing 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, azole antifungals, such as itraconazole and ketoconazole, macrolide antibiotics, such as erythromycin and clarithromycin, protease inhibitors, nefazodone, verapamil, amiodarone or large quantity of grapefruit juice (≥ 1l/day) patients on treatment with anti arrhythmic agents, other than beta-adrenergic receptor blockers.
boolean
C1449704 (UMLS CUI [1])
C0027996 (UMLS CUI [2])
C3850070 (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])
C0064113 (UMLS CUI [7])
C0022625 (UMLS CUI [8])
C0003240 (UMLS CUI [9])
C0014806 (UMLS CUI [10])
C0055856 (UMLS CUI [11])
C0033607 (UMLS CUI [12])
C0068485 (UMLS CUI [13])
C0042523 (UMLS CUI [14])
C0002598 (UMLS CUI [15])
C0452456 (UMLS CUI [16,1])
C3869890 (UMLS CUI [16,2])
C0003195 (UMLS CUI [17])
C1705847 (UMLS CUI [18,1])
C0304516 (UMLS CUI [18,2])
Terminal illness | Patient Inappropriate Placebo
Item
participant who is terminally ill or is inappropriate for placebo medication.
boolean
C0679247 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1696465 (UMLS CUI [2,3])
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