ID

35584

Beskrivning

Clinical Usefulness of Fractional Flow Reserve Measurement for Significant Stenosis in Proximal Coronary Artery; ODM derived from: https://clinicaltrials.gov/show/NCT02475291

Länk

https://clinicaltrials.gov/show/NCT02475291

Nyckelord

Versioner (1)
  1. 2019-03-11 2019-03-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02475291

Engelsk

Eligibility Coronary Artery Disease NCT02475291

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients ≥ 19 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
typical angina
Beskrivning

Typical angina

Datatyp

boolean

Alias
UMLS CUI [1]
C1998435
stable or unstable angina pectoris
Beskrivning

Stable angina | Angina, Unstable

Datatyp

boolean

Alias
UMLS CUI [1]
C0340288
UMLS CUI [2]
C0002965
at least one or more major epicardial coronary arteries with significant stenosis (>70% diameter stenosis by visual estimation on angiogram) confined to the proximal portion of left anterior descending artery, left circumflex artery, or right coronary artery
Beskrivning

Coronary artery Epicardial Major Quantity | Percent Diameter Stenosis Measurement Angiogram | Left anterior descending artery Proximal | Left circumflex artery Proximal | Right coronary artery Proximal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205042
UMLS CUI [1,2]
C0442016
UMLS CUI [1,3]
C0205164
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C3897965
UMLS CUI [2,2]
C0002978
UMLS CUI [3,1]
C0226032
UMLS CUI [3,2]
C0205107
UMLS CUI [4,1]
C1305727
UMLS CUI [4,2]
C0205107
UMLS CUI [5,1]
C0226042
UMLS CUI [5,2]
C0205107
reference vessel diameter of target lesion ≥3.0 mm
Beskrivning

Target Lesion | Reference Vessel Diameter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0221198
UMLS CUI [2,1]
C1706462
UMLS CUI [2,2]
C0005847
UMLS CUI [2,3]
C1301886
normal lv ejection fraction (≥50%) without wall motion abnormality by echocardiography
Beskrivning

Left ventricular ejection fraction Normal Echocardiography | Left ventricular wall motion abnormality Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C0013516
UMLS CUI [2,1]
C1997551
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous myocardial infarction
Beskrivning

Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
previous coronary bypass graft surgery
Beskrivning

Coronary Artery Bypass Surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0010055
cardiogenic shock
Beskrivning

Shock, Cardiogenic

Datatyp

boolean

Alias
UMLS CUI [1]
C0036980
multiple lesions in the vessel of interest
Beskrivning

Multiple lesions Vessel Relevant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0577305
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C2347946
contraindication or hypersensitivity to adenosine or contrast media
Beskrivning

Medical contraindication Adenosine | Adenosine allergy | Medical contraindication Contrast Media | Contrast media allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0001443
UMLS CUI [2]
C0571878
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0009924
UMLS CUI [4]
C0570562
reduced coronary blood flow (timi flow grade <3) in the vessel of interest
Beskrivning

Decreased blood flow Coronary Vessel Relevant | TIMI Flow

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232342
UMLS CUI [1,2]
C1522318
UMLS CUI [1,3]
C0005847
UMLS CUI [1,4]
C2347946
UMLS CUI [2]
C3272266
heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesions
Beskrivning

Lesion Calcified Very Angiogram | Lesion Tortuous Extreme

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0175895
UMLS CUI [1,3]
C0442824
UMLS CUI [1,4]
C0002978
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C4068863
UMLS CUI [2,3]
C0205403
pregnant women or women with potential childbearing
Beskrivning

Pregnancy | Childbearing Potential

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
inability to understand or read the informed content
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Coronary Artery Disease NCT02475291

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients ≥ 19 years old
boolean
C0001779 (UMLS CUI [1])
Typical angina
Item
typical angina
boolean
C1998435 (UMLS CUI [1])
Stable angina | Angina, Unstable
Item
stable or unstable angina pectoris
boolean
C0340288 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Coronary artery Epicardial Major Quantity | Percent Diameter Stenosis Measurement Angiogram | Left anterior descending artery Proximal | Left circumflex artery Proximal | Right coronary artery Proximal
Item
at least one or more major epicardial coronary arteries with significant stenosis (>70% diameter stenosis by visual estimation on angiogram) confined to the proximal portion of left anterior descending artery, left circumflex artery, or right coronary artery
boolean
C0205042 (UMLS CUI [1,1])
C0442016 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C3897965 (UMLS CUI [2,1])
C0002978 (UMLS CUI [2,2])
C0226032 (UMLS CUI [3,1])
C0205107 (UMLS CUI [3,2])
C1305727 (UMLS CUI [4,1])
C0205107 (UMLS CUI [4,2])
C0226042 (UMLS CUI [5,1])
C0205107 (UMLS CUI [5,2])
Target Lesion | Reference Vessel Diameter
Item
reference vessel diameter of target lesion ≥3.0 mm
boolean
C1521840 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1706462 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
Left ventricular ejection fraction Normal Echocardiography | Left ventricular wall motion abnormality Absent
Item
normal lv ejection fraction (≥50%) without wall motion abnormality by echocardiography
boolean
C0428772 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
C1997551 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Myocardial Infarction
Item
previous myocardial infarction
boolean
C0027051 (UMLS CUI [1])
Coronary Artery Bypass Surgery
Item
previous coronary bypass graft surgery
boolean
C0010055 (UMLS CUI [1])
Shock, Cardiogenic
Item
cardiogenic shock
boolean
C0036980 (UMLS CUI [1])
Multiple lesions Vessel Relevant
Item
multiple lesions in the vessel of interest
boolean
C0577305 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
Medical contraindication Adenosine | Adenosine allergy | Medical contraindication Contrast Media | Contrast media allergy
Item
contraindication or hypersensitivity to adenosine or contrast media
boolean
C1301624 (UMLS CUI [1,1])
C0001443 (UMLS CUI [1,2])
C0571878 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0009924 (UMLS CUI [3,2])
C0570562 (UMLS CUI [4])
Decreased blood flow Coronary Vessel Relevant | TIMI Flow
Item
reduced coronary blood flow (timi flow grade <3) in the vessel of interest
boolean
C0232342 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C2347946 (UMLS CUI [1,4])
C3272266 (UMLS CUI [2])
Lesion Calcified Very Angiogram | Lesion Tortuous Extreme
Item
heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesions
boolean
C0221198 (UMLS CUI [1,1])
C0175895 (UMLS CUI [1,2])
C0442824 (UMLS CUI [1,3])
C0002978 (UMLS CUI [1,4])
C0221198 (UMLS CUI [2,1])
C4068863 (UMLS CUI [2,2])
C0205403 (UMLS CUI [2,3])
Pregnancy | Childbearing Potential
Item
pregnant women or women with potential childbearing
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
Informed Consent Unable
Item
inability to understand or read the informed content
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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