ID

39882

Beschreibung

Cardiac GSI Feasibility Study; ODM derived from: https://clinicaltrials.gov/show/NCT01816750

Link

https://clinicaltrials.gov/show/NCT01816750

Stichworte

Versionen (1)
  1. 27.02.20 27.02.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. Februar 2020

DOI

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Eligibility High Risk of Significant Coronary Artery Disease NCT01816750

Englisch

Eligibility High Risk of Significant Coronary Artery Disease NCT01816750

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
accuracy arm
Beschreibung

Accuracy Arm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0443131
UMLS CUI [1,2]
C1522541
patients >50 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
suspected or known coronary artery disease referred for ica
Beschreibung

Coronary Artery Disease Suspected | Coronary Artery Disease | Referral for Coronary angiography Invasive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0750491
UMLS CUI [2]
C1956346
UMLS CUI [3,1]
C2585524
UMLS CUI [3,2]
C0085532
UMLS CUI [3,3]
C0205281
stress perfusion arm
Beschreibung

Stress Perfusion Arm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038435
UMLS CUI [1,2]
C0031001
UMLS CUI [1,3]
C1522541
patients >50 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
suspected or established coronary artery disease referred for mpi-spect for assessment of inducible ischaemia
Beschreibung

Coronary Artery Disease Suspected | Coronary Artery Disease | Referral for MPI-SPECT | Inducible Myocardial Ischemia Assessment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0750491
UMLS CUI [2]
C1956346
UMLS CUI [3,1]
C2585524
UMLS CUI [3,2]
C2350390
UMLS CUI [3,3]
C0040399
UMLS CUI [4,1]
C3898766
UMLS CUI [4,2]
C1516048
delayed enhancement arm
Beschreibung

Enhancement Delayed Arm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2349975
UMLS CUI [1,2]
C0205421
UMLS CUI [1,3]
C1522541
patients >50 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
referred for cmr for assessment of myocardial viability/scar
Beschreibung

Referral for MRI of Heart | Viability Myocardial Assessment | Myocardial scar Assessment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2585524
UMLS CUI [1,2]
C0412692
UMLS CUI [2,1]
C0443348
UMLS CUI [2,2]
C1522564
UMLS CUI [2,3]
C1516048
UMLS CUI [3,1]
C1404481
UMLS CUI [3,2]
C1516048
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
accuracy arm
Beschreibung

Accuracy Arm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0443131
UMLS CUI [1,2]
C1522541
consent cannot be obtained
Beschreibung

Informed Consent Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
patient bmi > 30 kg /m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
nyha class iii or iv heart failure
Beschreibung

Heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
chronic total occlusion of target epicardial coronary artery
Beschreibung

Chronic total occlusion of coronary artery Epicardial Targeted

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1955779
UMLS CUI [1,2]
C0442016
UMLS CUI [1,3]
C1521840
urgent revascularisation required
Beschreibung

Revascularization Urgent Required

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0581603
UMLS CUI [1,2]
C0439609
UMLS CUI [1,3]
C1514873
allergy to iodinated contrast or previous contrast induced nephropathy
Beschreibung

Hypersensitivity Iodinated contrast agent | Contrast - Induced Nephropathy Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0879373
UMLS CUI [2,1]
C4055183
UMLS CUI [2,2]
C0205156
intolerance or contraindication to beta-blockers
Beschreibung

Intolerance to Adrenergic beta-1 Receptor Antagonists | Medical contraindication Adrenergic beta-1 Receptor Antagonists

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0304516
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0304516
uncontrolled heart rhythm disturbances
Beschreibung

Cardiac Arrhythmia Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205318
2nd or 3rd degree atrioventricular block
Beschreibung

Second degree atrioventricular block | Complete atrioventricular block

Datentyp

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
estimated glomerular filtration rate <30ml/min within two weeks prior to procedure or chronic renal failure on dialysis
Beschreibung

Estimated Glomerular Filtration Rate | Kidney Failure, Chronic | Dialysis

Datentyp

boolean

Alias
UMLS CUI [1]
C3811844
UMLS CUI [2]
C0022661
UMLS CUI [3]
C0011946
pregnancy
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
stress perfusion arm
Beschreibung

Stress Perfusion Arm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038435
UMLS CUI [1,2]
C0031001
UMLS CUI [1,3]
C1522541
as above, plus:
Beschreibung

Equal above | Plus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205163
UMLS CUI [1,2]
C1282910
UMLS CUI [2]
C0332287
asthma (any) or intolerance to adenosine
Beschreibung

Asthma | Intolerance to Adenosine

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0001443
delayed enhancement arm
Beschreibung

Enhancement Delayed Arm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2349975
UMLS CUI [1,2]
C0205421
UMLS CUI [1,3]
C1522541
as for accuracy arm
Beschreibung

Accuracy Arm Equal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0443131
UMLS CUI [1,2]
C1522541
UMLS CUI [1,3]
C0205163
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Ähnliche Modelle

Eligibility High Risk of Significant Coronary Artery Disease NCT01816750

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Accuracy Arm
Item
accuracy arm
boolean
C0443131 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
Age
Item
patients >50 years of age
boolean
C0001779 (UMLS CUI [1])
Coronary Artery Disease Suspected | Coronary Artery Disease | Referral for Coronary angiography Invasive
Item
suspected or known coronary artery disease referred for ica
boolean
C1956346 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C1956346 (UMLS CUI [2])
C2585524 (UMLS CUI [3,1])
C0085532 (UMLS CUI [3,2])
C0205281 (UMLS CUI [3,3])
Stress Perfusion Arm
Item
stress perfusion arm
boolean
C0038435 (UMLS CUI [1,1])
C0031001 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,3])
Age
Item
patients >50 years of age
boolean
C0001779 (UMLS CUI [1])
Coronary Artery Disease Suspected | Coronary Artery Disease | Referral for MPI-SPECT | Inducible Myocardial Ischemia Assessment
Item
suspected or established coronary artery disease referred for mpi-spect for assessment of inducible ischaemia
boolean
C1956346 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C1956346 (UMLS CUI [2])
C2585524 (UMLS CUI [3,1])
C2350390 (UMLS CUI [3,2])
C0040399 (UMLS CUI [3,3])
C3898766 (UMLS CUI [4,1])
C1516048 (UMLS CUI [4,2])
Enhancement Delayed Arm
Item
delayed enhancement arm
boolean
C2349975 (UMLS CUI [1,1])
C0205421 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,3])
Age
Item
patients >50 years of age
boolean
C0001779 (UMLS CUI [1])
Referral for MRI of Heart | Viability Myocardial Assessment | Myocardial scar Assessment
Item
referred for cmr for assessment of myocardial viability/scar
boolean
C2585524 (UMLS CUI [1,1])
C0412692 (UMLS CUI [1,2])
C0443348 (UMLS CUI [2,1])
C1522564 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C1404481 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Accuracy Arm
Item
accuracy arm
boolean
C0443131 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
Informed Consent Lacking
Item
consent cannot be obtained
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Body mass index
Item
patient bmi > 30 kg /m2
boolean
C1305855 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
nyha class iii or iv heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Chronic total occlusion of coronary artery Epicardial Targeted
Item
chronic total occlusion of target epicardial coronary artery
boolean
C1955779 (UMLS CUI [1,1])
C0442016 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
Revascularization Urgent Required
Item
urgent revascularisation required
boolean
C0581603 (UMLS CUI [1,1])
C0439609 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
Hypersensitivity Iodinated contrast agent | Contrast - Induced Nephropathy Previous
Item
allergy to iodinated contrast or previous contrast induced nephropathy
boolean
C0020517 (UMLS CUI [1,1])
C0879373 (UMLS CUI [1,2])
C4055183 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Intolerance to Adrenergic beta-1 Receptor Antagonists | Medical contraindication Adrenergic beta-1 Receptor Antagonists
Item
intolerance or contraindication to beta-blockers
boolean
C1744706 (UMLS CUI [1,1])
C0304516 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0304516 (UMLS CUI [2,2])
Cardiac Arrhythmia Uncontrolled
Item
uncontrolled heart rhythm disturbances
boolean
C0003811 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Second degree atrioventricular block | Complete atrioventricular block
Item
2nd or 3rd degree atrioventricular block
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
Estimated Glomerular Filtration Rate | Kidney Failure, Chronic | Dialysis
Item
estimated glomerular filtration rate <30ml/min within two weeks prior to procedure or chronic renal failure on dialysis
boolean
C3811844 (UMLS CUI [1])
C0022661 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Stress Perfusion Arm
Item
stress perfusion arm
boolean
C0038435 (UMLS CUI [1,1])
C0031001 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,3])
Equal above | Plus
Item
as above, plus:
boolean
C0205163 (UMLS CUI [1,1])
C1282910 (UMLS CUI [1,2])
C0332287 (UMLS CUI [2])
Asthma | Intolerance to Adenosine
Item
asthma (any) or intolerance to adenosine
boolean
C0004096 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0001443 (UMLS CUI [2,2])
Enhancement Delayed Arm
Item
delayed enhancement arm
boolean
C2349975 (UMLS CUI [1,1])
C0205421 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,3])
Accuracy Arm Equal
Item
as for accuracy arm
boolean
C0443131 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
C0205163 (UMLS CUI [1,3])
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