ID

40860

Beskrivning

A Trial to Evaluate a New Strategy in the Functional Assessment of 3-vessel Disease Using the SYNTAX II Score in Patients Treated With PCI; ODM derived from: https://clinicaltrials.gov/show/NCT02015832

Länk

https://clinicaltrials.gov/show/NCT02015832

Nyckelord

Versioner (1)
  1. 2020-05-27 2020-05-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 maj 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Diseases NCT02015832

Engelsk

Eligibility Heart Diseases NCT02015832

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
at least 1 stenosis, angiographic, visually determined de novo lesions with more than 50 percent diameter stenosis in all 3 major epicardial territories. these are left descending coronary artery (lad) and or side branch, proximal circumflex coronary artery (lcx) and or side branch, right descending coronary artery (rca) and or side branch which are supplying viable myocardium without left main involvement. patients with ostial lad or ostial cx medina 0,0,1 or medina 0,1,0 may be enrolled
Beskrivning

Stenosis Quantity Angiography | Lesion de novo | Stenosis Diameter Percentage | Left Anterior Descending artery | Left circumflex artery | Right coronary artery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1261287
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0002978
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1515568
UMLS CUI [3,1]
C1261287
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0439165
UMLS CUI [4]
C0226032
UMLS CUI [5]
C1305727
UMLS CUI [6]
C0226042
patients with hypoplastic rca with absence of descending posterior and presence of a lesion in the lad and cx territories may be included in the trial as a 3 vessel disease equivalent
Beskrivning

Right coronary artery Hypoplastic | Posterior descending artery Lesion Absent | Left anterior descending artery Lesion | Circumflex artery Lesion | Triple vessel disease Equivalent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0226042
UMLS CUI [1,2]
C0543481
UMLS CUI [2,1]
C0500492
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C1321506
UMLS CUI [3,2]
C0221198
UMLS CUI [4,1]
C1305727
UMLS CUI [4,2]
C0221198
UMLS CUI [5,1]
C0856738
UMLS CUI [5,2]
C0205163
vessel size should be at least 1.5 mm in diameter as visually assessed in diagnostic angiogram
Beskrivning

Vessel Size Diameter | Vessel Angiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005847
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C1301886
UMLS CUI [2,1]
C0005847
UMLS CUI [2,2]
C0002978
patients with
Beskrivning

Patients Have

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3539897
1. stable (canadian cardiovascular society class 1, 2, 3 or 4) angina pectoris
Beskrivning

Stable angina CCS Class

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0340288
UMLS CUI [1,2]
C1879987
2. or unstable (braunwald class) angina pectoris and ischemia
Beskrivning

Unstable Angina Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002965
UMLS CUI [1,2]
C0008902
3. or patients with atypical chest pain or those who are asymptomatic provided they have myocardial ischemia, for example treadmill exercise test, radionuclide scintigraphy, stress echocardiography
Beskrivning

Atypical chest pain | Myocardial Ischemia Asymptomatic | Stress test treadmill | Radionuclide Imaging | Stress Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0262384
UMLS CUI [2,1]
C0151744
UMLS CUI [2,2]
C0231221
UMLS CUI [3]
C3878122
UMLS CUI [4]
C0034606
UMLS CUI [5,1]
C0038435
UMLS CUI [5,2]
C0013516
all anatomical syntax scores are eligible for initial screening with the syntax score ii
Beskrivning

Coronary Artery Disease Score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0449820
patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the ethical committee of the respective clinical site
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
signed heart team decision form between local cardiologist and surgeon that the selected case meets all of the inclusion and exclusion criteria
Beskrivning

Cardiologist Approval | Surgeon Approval | Eligibility Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0175906
UMLS CUI [1,2]
C0205540
UMLS CUI [2,1]
C0582175
UMLS CUI [2,2]
C0205540
UMLS CUI [3,1]
C1516637
UMLS CUI [3,2]
C1550543
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
under the age of 21 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
known pregnancy at time of enrolment. female of childbearing potential, and last menstruation within the last 12 months, who are not taking adequate contraceptives. female who is breastfeeding at time of enrolment
Beskrivning

Pregnancy | Childbearing Potential Contraceptive methods Absent | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0006147
prior pci or cabg
Beskrivning

Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2]
C0010055
ongoing acute myocardial infarction and enzymes (ckmb) more than 2x upper limit of normal
Beskrivning

Myocardial Infarction | Creatine kinase MB increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0861005
concomitant cardiac valve disease requiring surgical therapy, reconstruction or replacement
Beskrivning

Heart valve disease Requirement Operative Surgical Procedure | Heart valve disease Requirement Reconstructive Surgical Procedure | Heart valve disease Requirement Surgical replacement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C0018824
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0524865
UMLS CUI [3,1]
C0018824
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C4076286
single or two-vessel disease at time of heart team consensus
Beskrivning

Single vessel disease | Double vessel disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0856737
UMLS CUI [2]
C0919945
participation or planned participation in another cardiovascular clinical study before one year follow up is completed
Beskrivning

Study Subject Participation Status | Clinical Trial Cardiovascular

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C3887460
mental condition, psychiatric or organ cerebral disease, rendering the subject unable to understand the nature, scope, and possible consequences of the study or mental retardation or language barrier such that the patient is unable to give informed consent and potential for non-compliance towards the requirement in the study protocol
Beskrivning

Mental condition | Mental disorders | Cerebral disorder | Study Protocol Comprehension Unable | Mental Retardation | Language Barriers | Informed Consent Unable | Protocol Compliance Unlikely

Datatyp

boolean

Alias
UMLS CUI [1]
C3840291
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0234387
UMLS CUI [4,1]
C2348563
UMLS CUI [4,2]
C0162340
UMLS CUI [4,3]
C1299582
UMLS CUI [5]
C0025362
UMLS CUI [6]
C0237167
UMLS CUI [7,1]
C0021430
UMLS CUI [7,2]
C1299582
UMLS CUI [8,1]
C0525058
UMLS CUI [8,2]
C0750558
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Similar models

Eligibility Heart Diseases NCT02015832

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Stenosis Quantity Angiography | Lesion de novo | Stenosis Diameter Percentage | Left Anterior Descending artery | Left circumflex artery | Right coronary artery
Item
at least 1 stenosis, angiographic, visually determined de novo lesions with more than 50 percent diameter stenosis in all 3 major epicardial territories. these are left descending coronary artery (lad) and or side branch, proximal circumflex coronary artery (lcx) and or side branch, right descending coronary artery (rca) and or side branch which are supplying viable myocardium without left main involvement. patients with ostial lad or ostial cx medina 0,0,1 or medina 0,1,0 may be enrolled
boolean
C1261287 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0002978 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
C1261287 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0439165 (UMLS CUI [3,3])
C0226032 (UMLS CUI [4])
C1305727 (UMLS CUI [5])
C0226042 (UMLS CUI [6])
Right coronary artery Hypoplastic | Posterior descending artery Lesion Absent | Left anterior descending artery Lesion | Circumflex artery Lesion | Triple vessel disease Equivalent
Item
patients with hypoplastic rca with absence of descending posterior and presence of a lesion in the lad and cx territories may be included in the trial as a 3 vessel disease equivalent
boolean
C0226042 (UMLS CUI [1,1])
C0543481 (UMLS CUI [1,2])
C0500492 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1321506 (UMLS CUI [3,1])
C0221198 (UMLS CUI [3,2])
C1305727 (UMLS CUI [4,1])
C0221198 (UMLS CUI [4,2])
C0856738 (UMLS CUI [5,1])
C0205163 (UMLS CUI [5,2])
Vessel Size Diameter | Vessel Angiography
Item
vessel size should be at least 1.5 mm in diameter as visually assessed in diagnostic angiogram
boolean
C0005847 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0005847 (UMLS CUI [2,1])
C0002978 (UMLS CUI [2,2])
Patients Have
Item
patients with
boolean
C0030705 (UMLS CUI [1,1])
C3539897 (UMLS CUI [1,2])
Stable angina CCS Class
Item
1. stable (canadian cardiovascular society class 1, 2, 3 or 4) angina pectoris
boolean
C0340288 (UMLS CUI [1,1])
C1879987 (UMLS CUI [1,2])
Unstable Angina Classification
Item
2. or unstable (braunwald class) angina pectoris and ischemia
boolean
C0002965 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
Atypical chest pain | Myocardial Ischemia Asymptomatic | Stress test treadmill | Radionuclide Imaging | Stress Echocardiography
Item
3. or patients with atypical chest pain or those who are asymptomatic provided they have myocardial ischemia, for example treadmill exercise test, radionuclide scintigraphy, stress echocardiography
boolean
C0262384 (UMLS CUI [1])
C0151744 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C3878122 (UMLS CUI [3])
C0034606 (UMLS CUI [4])
C0038435 (UMLS CUI [5,1])
C0013516 (UMLS CUI [5,2])
Coronary Artery Disease Score
Item
all anatomical syntax scores are eligible for initial screening with the syntax score ii
boolean
C1956346 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Informed Consent
Item
patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the ethical committee of the respective clinical site
boolean
C0021430 (UMLS CUI [1])
Cardiologist Approval | Surgeon Approval | Eligibility Criteria Fulfill
Item
signed heart team decision form between local cardiologist and surgeon that the selected case meets all of the inclusion and exclusion criteria
boolean
C0175906 (UMLS CUI [1,1])
C0205540 (UMLS CUI [1,2])
C0582175 (UMLS CUI [2,1])
C0205540 (UMLS CUI [2,2])
C1516637 (UMLS CUI [3,1])
C1550543 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
under the age of 21 years
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods Absent | Breast Feeding
Item
known pregnancy at time of enrolment. female of childbearing potential, and last menstruation within the last 12 months, who are not taking adequate contraceptives. female who is breastfeeding at time of enrolment
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0006147 (UMLS CUI [3])
Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
Item
prior pci or cabg
boolean
C1532338 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
Myocardial Infarction | Creatine kinase MB increased
Item
ongoing acute myocardial infarction and enzymes (ckmb) more than 2x upper limit of normal
boolean
C0027051 (UMLS CUI [1])
C0861005 (UMLS CUI [2])
Heart valve disease Requirement Operative Surgical Procedure | Heart valve disease Requirement Reconstructive Surgical Procedure | Heart valve disease Requirement Surgical replacement
Item
concomitant cardiac valve disease requiring surgical therapy, reconstruction or replacement
boolean
C0018824 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0018824 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0524865 (UMLS CUI [2,3])
C0018824 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C4076286 (UMLS CUI [3,3])
Single vessel disease | Double vessel disease
Item
single or two-vessel disease at time of heart team consensus
boolean
C0856737 (UMLS CUI [1])
C0919945 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial Cardiovascular
Item
participation or planned participation in another cardiovascular clinical study before one year follow up is completed
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C3887460 (UMLS CUI [2,2])
Mental condition | Mental disorders | Cerebral disorder | Study Protocol Comprehension Unable | Mental Retardation | Language Barriers | Informed Consent Unable | Protocol Compliance Unlikely
Item
mental condition, psychiatric or organ cerebral disease, rendering the subject unable to understand the nature, scope, and possible consequences of the study or mental retardation or language barrier such that the patient is unable to give informed consent and potential for non-compliance towards the requirement in the study protocol
boolean
C3840291 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0234387 (UMLS CUI [3])
C2348563 (UMLS CUI [4,1])
C0162340 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
C0025362 (UMLS CUI [5])
C0237167 (UMLS CUI [6])
C0021430 (UMLS CUI [7,1])
C1299582 (UMLS CUI [7,2])
C0525058 (UMLS CUI [8,1])
C0750558 (UMLS CUI [8,2])
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