ID

15625

Beschreibung

Revascularization With BVS or CABG in Patients With Advanced CAD; ODM derived from: https://clinicaltrials.gov/show/NCT02334826

Link

https://clinicaltrials.gov/show/NCT02334826

Stichworte

Versionen (1)
  1. 06.06.16 06.06.16 -
Hochgeladen am

6. Juni 2016

DOI

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Creative Commons BY 4.0
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Eligibility Multivessel Coronary Artery Disease NCT02334826

Englisch

Eligibility Multivessel Coronary Artery Disease NCT02334826

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient age ≥18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patient with symptomatic stable cad or silent ischemia, with 3-vessel disease and/or significant stenosis of left main coronary artery on angiography, with significant ischemia evaluated in stress cmr
Beschreibung

Coronary Artery Disease Symptomatic Stable status | Silent myocardial ischemia | Triple vessel disease of the heart | Left main coronary artery stenosis | angiogram | Ischemia | Stress Cardiac Magnetic Resonance Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0340291
UMLS CUI [3]
C0340285
UMLS CUI [4]
C2062905
UMLS CUI [5]
C0002978
UMLS CUI [6]
C0022116
UMLS CUI [7]
C2825166
patient suitable for both pci or cabg after local heart team evaluation
Beschreibung

suitable Percutaneous Coronary Intervention | suitable Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3900053
UMLS CUI [1,2]
C1532338
UMLS CUI [2,1]
C3900053
UMLS CUI [2,2]
C0010055
patient understands and accepts the meaning and the aims of the study and is willing to sign written informed consent
Beschreibung

Comprehension Study Protocol | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior cabg
Beschreibung

Coronary Artery Bypass Surgery Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C0205156
concomitant valve disease requiring cardiac surgery
Beschreibung

Heart valve disease Simultaneous | Requirement Cardiac Surgery procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0521115
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0018821
metal implants that may be the contraindication for cmr examination (e.g. peacemaker, icd)
Beschreibung

Implants Metallic | Medical contraindication Stress Cardiac Magnetic Resonance Imaging | Artificial cardiac pacemaker | Implantable defibrillator

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C2986473
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C2825166
UMLS CUI [3]
C0030163
UMLS CUI [4]
C0162589
other contraindication for stress cmr or computed tomography (claustrophobia, asthma, a-v bloc, allergy to radiographic contrast or any prior anaphylaxis to contrast)
Beschreibung

Medical contraindication Stress Cardiac Magnetic Resonance Imaging | Medical contraindication X-Ray Computed Tomography | Claustrophobia | Asthma | Atrioventricular Block | allergic reaction to radiographic contrast material | anaphylaxis Contrast Media

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2825166
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0040405
UMLS CUI [3]
C0008909
UMLS CUI [4]
C0004096
UMLS CUI [5]
C0004245
UMLS CUI [6]
C2215744
UMLS CUI [7,1]
C0002792
UMLS CUI [7,2]
C0009924
contraindication for 12 months dual antiplatelet therapy (dapt) or known allergy to acetylsalicylic acid, clopidogrel or ticagrelor
Beschreibung

Medical contraindication Antiplatelet agent therapy Dual | Hypersensitivity Aspirin | Hypersensitivity clopidogrel | Hypersensitivity Ticagrelor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2585481
UMLS CUI [1,3]
C1547278
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0004057
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0070166
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1999375
female patient with child bearing potential
Beschreibung

Gender | Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C3831118
acute coronary syndrome within 2 weeks prior to revascularization
Beschreibung

Acute Coronary Syndrome | Revascularization

Datentyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0581603
significant stenosis of any vessel, including lm if reference diameter > 4mm
Beschreibung

Stenosis Blood Vessel | Stenosis Left coronary artery main stem

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1261287
UMLS CUI [1,2]
C0005847
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C0226031
left ventricular ejection fraction (lvef) <35%
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
life expectancy < 12 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
stroke or transient ischemic attack (tia) within 3 months prior to revascularization
Beschreibung

Cerebrovascular accident | Transient Ischemic Attack | Revascularization

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
UMLS CUI [3]
C0581603
chronic kidney disease, estimated glomerular filtration rate (egfr) <30 ml/min/1.73m2
Beschreibung

Chronic Kidney Diseases | Estimated Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C1561643
UMLS CUI [2]
C3811844
planned surgery (other than cabg) within 12 months after randomization
Beschreibung

Operative Surgical Procedures Planned | Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C0010055
diathesis, chronic oral anticoagulation therapy or history of bleeding
Beschreibung

Disease susceptibility | Therapeutic procedure oral anticoagulants chronic | Hemorrhage

Datentyp

boolean

Alias
UMLS CUI [1]
C0012655
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0354604
UMLS CUI [2,3]
C0205191
UMLS CUI [3]
C0019080
current participation in another trial or registry
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Multivessel Coronary Artery Disease NCT02334826

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Coronary Artery Disease Symptomatic Stable status | Silent myocardial ischemia | Triple vessel disease of the heart | Left main coronary artery stenosis | angiogram | Ischemia | Stress Cardiac Magnetic Resonance Imaging
Item
patient with symptomatic stable cad or silent ischemia, with 3-vessel disease and/or significant stenosis of left main coronary artery on angiography, with significant ischemia evaluated in stress cmr
boolean
C1956346 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0340291 (UMLS CUI [2])
C0340285 (UMLS CUI [3])
C2062905 (UMLS CUI [4])
C0002978 (UMLS CUI [5])
C0022116 (UMLS CUI [6])
C2825166 (UMLS CUI [7])
suitable Percutaneous Coronary Intervention | suitable Coronary Artery Bypass Surgery
Item
patient suitable for both pci or cabg after local heart team evaluation
boolean
C3900053 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C3900053 (UMLS CUI [2,1])
C0010055 (UMLS CUI [2,2])
Comprehension Study Protocol | Informed Consent
Item
patient understands and accepts the meaning and the aims of the study and is willing to sign written informed consent
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Coronary Artery Bypass Surgery Previous
Item
prior cabg
boolean
C0010055 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Heart valve disease Simultaneous | Requirement Cardiac Surgery procedures
Item
concomitant valve disease requiring cardiac surgery
boolean
C0018824 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0018821 (UMLS CUI [2,2])
Implants Metallic | Medical contraindication Stress Cardiac Magnetic Resonance Imaging | Artificial cardiac pacemaker | Implantable defibrillator
Item
metal implants that may be the contraindication for cmr examination (e.g. peacemaker, icd)
boolean
C0021102 (UMLS CUI [1,1])
C2986473 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C2825166 (UMLS CUI [2,2])
C0030163 (UMLS CUI [3])
C0162589 (UMLS CUI [4])
Medical contraindication Stress Cardiac Magnetic Resonance Imaging | Medical contraindication X-Ray Computed Tomography | Claustrophobia | Asthma | Atrioventricular Block | allergic reaction to radiographic contrast material | anaphylaxis Contrast Media
Item
other contraindication for stress cmr or computed tomography (claustrophobia, asthma, a-v bloc, allergy to radiographic contrast or any prior anaphylaxis to contrast)
boolean
C1301624 (UMLS CUI [1,1])
C2825166 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0008909 (UMLS CUI [3])
C0004096 (UMLS CUI [4])
C0004245 (UMLS CUI [5])
C2215744 (UMLS CUI [6])
C0002792 (UMLS CUI [7,1])
C0009924 (UMLS CUI [7,2])
Medical contraindication Antiplatelet agent therapy Dual | Hypersensitivity Aspirin | Hypersensitivity clopidogrel | Hypersensitivity Ticagrelor
Item
contraindication for 12 months dual antiplatelet therapy (dapt) or known allergy to acetylsalicylic acid, clopidogrel or ticagrelor
boolean
C1301624 (UMLS CUI [1,1])
C2585481 (UMLS CUI [1,2])
C1547278 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1999375 (UMLS CUI [4,2])
Gender | Childbearing Potential
Item
female patient with child bearing potential
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
Acute Coronary Syndrome | Revascularization
Item
acute coronary syndrome within 2 weeks prior to revascularization
boolean
C0948089 (UMLS CUI [1])
C0581603 (UMLS CUI [2])
Stenosis Blood Vessel | Stenosis Left coronary artery main stem
Item
significant stenosis of any vessel, including lm if reference diameter > 4mm
boolean
C1261287 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1261287 (UMLS CUI [2,1])
C0226031 (UMLS CUI [2,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) <35%
boolean
C0428772 (UMLS CUI [1])
Life Expectancy
Item
life expectancy < 12 months
boolean
C0023671 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack | Revascularization
Item
stroke or transient ischemic attack (tia) within 3 months prior to revascularization
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0581603 (UMLS CUI [3])
Chronic Kidney Diseases | Estimated Glomerular Filtration Rate
Item
chronic kidney disease, estimated glomerular filtration rate (egfr) <30 ml/min/1.73m2
boolean
C1561643 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Operative Surgical Procedures Planned | Coronary Artery Bypass Surgery
Item
planned surgery (other than cabg) within 12 months after randomization
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0010055 (UMLS CUI [2])
Disease susceptibility | Therapeutic procedure oral anticoagulants chronic | Hemorrhage
Item
diathesis, chronic oral anticoagulation therapy or history of bleeding
boolean
C0012655 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0354604 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0019080 (UMLS CUI [3])
Study Subject Participation Status
Item
current participation in another trial or registry
boolean
C2348568 (UMLS CUI [1])
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