ID

37484

Beschrijving

Minocycline Plus Amiodarone Versus Amiodarone Alone for the Prevention of Atrial Fibrillation After Cardiac Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT01422148

Link

https://clinicaltrials.gov/show/NCT01422148

Trefwoorden

Versies (1)
  1. 01-08-19 01-08-19 -
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See clinicaltrials.gov

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1 augustus 2019

DOI

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Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01422148

Engels

Eligibility Atrial Fibrillation NCT01422148

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
eligibility criteria includes all non-congenital cardiac operations are included:
Beschrijving

Cardiac Surgery procedures | Exception Congenital cardiac surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0018821
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0850110
coronary artery bypass graft (cabg),
Beschrijving

Coronary Artery Bypass Surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0010055
valve repair/replacement, or
Beschrijving

Repair of heart valve | Valve replacement

Datatype

boolean

Alias
UMLS CUI [1]
C0190112
UMLS CUI [2]
C1410969
combination of cabg and heart valve operations.
Beschrijving

Combination Coronary Artery Bypass Surgery Operation on heart valve

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205195
UMLS CUI [1,2]
C0010055
UMLS CUI [1,3]
C0190065
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior (within 6 months) or current paf or flutter,
Beschrijving

Paroxysmal atrial fibrillation | Paroxysmal atrial flutter

Datatype

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C0741292
prior cerebrovascular event,
Beschrijving

Event Cerebrovascular

Datatype

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1880018
cardiogenic shock or resuscitation,
Beschrijving

Shock, Cardiogenic | Resuscitation

Datatype

boolean

Alias
UMLS CUI [1]
C0036980
UMLS CUI [2]
C0035273
evidence of hepatic or renal dysfunctions (i.e., an alanine aminotransferase level that is ≥ twice the upper limit of the normal range, or either a serum creatinine level that is ≥ 2.0 mg/dl or need for preoperative dialysis),
Beschrijving

Liver Dysfunction | Renal dysfunction | Alanine aminotransferase increased | Creatinine measurement, serum | Patient need for Dialysis Preoperative

Datatype

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C3279454
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0201976
UMLS CUI [5,1]
C0686904
UMLS CUI [5,2]
C0011946
UMLS CUI [5,3]
C0445204
thyrotoxicosis,
Beschrijving

Thyrotoxicosis

Datatype

boolean

Alias
UMLS CUI [1]
C0040156
pregnancy,
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
severe copd (fev1/fvc <70%),
Beschrijving

Severe COPD | FEV1/FVC percent

Datatype

boolean

Alias
UMLS CUI [1]
C0730607
UMLS CUI [2]
C0730560
recent history of drug or alcohol abuse, and
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
intolerance to tetracycline or amiodarone.
Beschrijving

Intolerance to Tetracycline | Intolerance to Amiodarone

Datatype

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0039644
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0002598
finally, because a core scientific basis of the trial concerned the role of underlying atrial tissue inflammatory activity, patients with inflammatory conditions such as lupus, severe arthritis, thyroiditis or inflammatory bowel disease are excluded; as are patients taking preoperative immunosuppressant agents, long-term oral corticosteroids, or estrogen replacement; and a newly diagnosed cancer (<5 years).
Beschrijving

Inflammatory disorder | Lupus Erythematosus | Arthritis Severe | Thyroiditis | Inflammatory Bowel Diseases | Immunosuppressive Agents Preoperative | Adrenal Cortex Hormones Oral Long-term | Estrogen Replacement | Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C1290884
UMLS CUI [2]
C0409974
UMLS CUI [3,1]
C0003864
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0040147
UMLS CUI [5]
C0021390
UMLS CUI [6,1]
C0021081
UMLS CUI [6,2]
C0445204
UMLS CUI [7,1]
C0001617
UMLS CUI [7,2]
C1527415
UMLS CUI [7,3]
C0443252
UMLS CUI [8]
C0086258
UMLS CUI [9]
C0006826
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Similar models

Eligibility Atrial Fibrillation NCT01422148

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Cardiac Surgery procedures | Exception Congenital cardiac surgery
Item
eligibility criteria includes all non-congenital cardiac operations are included:
boolean
C0018821 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0850110 (UMLS CUI [2,2])
Coronary Artery Bypass Surgery
Item
coronary artery bypass graft (cabg),
boolean
C0010055 (UMLS CUI [1])
Repair of heart valve | Valve replacement
Item
valve repair/replacement, or
boolean
C0190112 (UMLS CUI [1])
C1410969 (UMLS CUI [2])
Combination Coronary Artery Bypass Surgery Operation on heart valve
Item
combination of cabg and heart valve operations.
boolean
C0205195 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
C0190065 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Paroxysmal atrial fibrillation | Paroxysmal atrial flutter
Item
prior (within 6 months) or current paf or flutter,
boolean
C0235480 (UMLS CUI [1])
C0741292 (UMLS CUI [2])
Event Cerebrovascular
Item
prior cerebrovascular event,
boolean
C0441471 (UMLS CUI [1,1])
C1880018 (UMLS CUI [1,2])
Shock, Cardiogenic | Resuscitation
Item
cardiogenic shock or resuscitation,
boolean
C0036980 (UMLS CUI [1])
C0035273 (UMLS CUI [2])
Liver Dysfunction | Renal dysfunction | Alanine aminotransferase increased | Creatinine measurement, serum | Patient need for Dialysis Preoperative
Item
evidence of hepatic or renal dysfunctions (i.e., an alanine aminotransferase level that is ≥ twice the upper limit of the normal range, or either a serum creatinine level that is ≥ 2.0 mg/dl or need for preoperative dialysis),
boolean
C0086565 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0686904 (UMLS CUI [5,1])
C0011946 (UMLS CUI [5,2])
C0445204 (UMLS CUI [5,3])
Thyrotoxicosis
Item
thyrotoxicosis,
boolean
C0040156 (UMLS CUI [1])
Pregnancy
Item
pregnancy,
boolean
C0032961 (UMLS CUI [1])
Severe COPD | FEV1/FVC percent
Item
severe copd (fev1/fvc <70%),
boolean
C0730607 (UMLS CUI [1])
C0730560 (UMLS CUI [2])
Substance Use Disorders
Item
recent history of drug or alcohol abuse, and
boolean
C0038586 (UMLS CUI [1])
Intolerance to Tetracycline | Intolerance to Amiodarone
Item
intolerance to tetracycline or amiodarone.
boolean
C1744706 (UMLS CUI [1,1])
C0039644 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0002598 (UMLS CUI [2,2])
Inflammatory disorder | Lupus Erythematosus | Arthritis Severe | Thyroiditis | Inflammatory Bowel Diseases | Immunosuppressive Agents Preoperative | Adrenal Cortex Hormones Oral Long-term | Estrogen Replacement | Malignant Neoplasms
Item
finally, because a core scientific basis of the trial concerned the role of underlying atrial tissue inflammatory activity, patients with inflammatory conditions such as lupus, severe arthritis, thyroiditis or inflammatory bowel disease are excluded; as are patients taking preoperative immunosuppressant agents, long-term oral corticosteroids, or estrogen replacement; and a newly diagnosed cancer (<5 years).
boolean
C1290884 (UMLS CUI [1])
C0409974 (UMLS CUI [2])
C0003864 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0040147 (UMLS CUI [4])
C0021390 (UMLS CUI [5])
C0021081 (UMLS CUI [6,1])
C0445204 (UMLS CUI [6,2])
C0001617 (UMLS CUI [7,1])
C1527415 (UMLS CUI [7,2])
C0443252 (UMLS CUI [7,3])
C0086258 (UMLS CUI [8])
C0006826 (UMLS CUI [9])
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