ID

14985

Beschrijving

Complexity of Bifurcation Lesions Treated With Optimal Strategies; ODM derived from: https://clinicaltrials.gov/show/NCT02284750

Link

https://clinicaltrials.gov/show/NCT02284750

Trefwoorden

  1. 10-05-16 10-05-16 -
Geüploaded op

10 mei 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Coronary Artery Disease NCT02284750

Eligibility Coronary Artery Disease NCT02284750

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of informed consent prior to any study specific procedures;
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
men and women 18 years and older;.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
established indication to pci according to the guidelines of american heart association and american college of cardiology;
Beschrijving

Indication Percutaneous Coronary Intervention | American Heart Association Guidelines

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1532338
UMLS CUI [2,1]
C0002458
UMLS CUI [2,2]
C0162791
native coronary lesion suitable for drug-eluting stent placement;
Beschrijving

Coronary Vessel Lesion Native | Amenable Drug-eluting coronary stent placement

Datatype

boolean

Alias
UMLS CUI [1,1]
C3272304
UMLS CUI [1,2]
C0302891
UMLS CUI [2,1]
C3900053
UMLS CUI [2,2]
C2609296
true bifurcation lesions (medina 0,1,1/1,1,1 /1,0,1);
Beschrijving

Bifurcation lesion of coronary artery

Datatype

boolean

Alias
UMLS CUI [1]
C1299363
reference vessel diameter in side branch ≥2.5mm by visual estimation.
Beschrijving

Mean Vessel Diameter | Visual estimation

Datatype

boolean

Alias
UMLS CUI [1]
C3898449
UMLS CUI [2]
C0444684
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy and breast feeding mother;
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
co-morbidity with an estimated life expectancy of < 50 % at 12 months;
Beschrijving

Comorbidity | Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0023671
scheduled major surgery in the next 12 months;
Beschrijving

Major surgery Scheduled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0205539
inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
Beschrijving

Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days;
Beschrijving

Study Subject Participation Status | Therapeutic procedure Investigational New Drugs | Therapeutic procedure Investigational Medical Device

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C2346570
known allergy against ticagrelor, or against clopidogrel, or aspirin history of major hemorrhage (intracranial, gastrointestinal, etc.);
Beschrijving

Hypersensitivity Ticagrelor | Hypersensitivity clopidogrel | History of chronic use of aspirin Hemorrhage Major | Intracranial Hemorrhages | Gastrointestinal Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1999375
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C2054132
UMLS CUI [3,2]
C0019080
UMLS CUI [3,3]
C0205164
UMLS CUI [4]
C0151699
UMLS CUI [5]
C0017181
chronic total occlusion lesion in either lad, or lcx or rca not re-canalized;
Beschrijving

chronic total occlusion Anterior descending branch of left coronary artery | chronic total occlusion Structure of circumflex branch of left coronary artery | chronic total occlusion Entire right coronary artery | recanalized

Datatype

boolean

Alias
UMLS CUI [1,1]
C3275069
UMLS CUI [1,2]
C0226032
UMLS CUI [2,1]
C3275069
UMLS CUI [2,2]
C0226037
UMLS CUI [3,1]
C3275069
UMLS CUI [3,2]
C0226042
UMLS CUI [4]
C0333328
severe calcification needing rotational atherectomy;
Beschrijving

Calcification Severe Needs Rotational Atherectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0175895
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0027552
UMLS CUI [1,4]
C0162655
patient with stemi (within 24-hour from the onset of chest pain to admission).
Beschrijving

ST segment elevation myocardial infarction | Chest Pain

Datatype

boolean

Alias
UMLS CUI [1]
C1536220
UMLS CUI [2]
C0008031

Similar models

Eligibility Coronary Artery Disease NCT02284750

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
provision of informed consent prior to any study specific procedures;
boolean
C0021430 (UMLS CUI [1])
Age
Item
men and women 18 years and older;.
boolean
C0001779 (UMLS CUI [1])
Indication Percutaneous Coronary Intervention | American Heart Association Guidelines
Item
established indication to pci according to the guidelines of american heart association and american college of cardiology;
boolean
C3146298 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0002458 (UMLS CUI [2,1])
C0162791 (UMLS CUI [2,2])
Coronary Vessel Lesion Native | Amenable Drug-eluting coronary stent placement
Item
native coronary lesion suitable for drug-eluting stent placement;
boolean
C3272304 (UMLS CUI [1,1])
C0302891 (UMLS CUI [1,2])
C3900053 (UMLS CUI [2,1])
C2609296 (UMLS CUI [2,2])
Bifurcation lesion of coronary artery
Item
true bifurcation lesions (medina 0,1,1/1,1,1 /1,0,1);
boolean
C1299363 (UMLS CUI [1])
Mean Vessel Diameter | Visual estimation
Item
reference vessel diameter in side branch ≥2.5mm by visual estimation.
boolean
C3898449 (UMLS CUI [1])
C0444684 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnancy and breast feeding mother;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity | Life Expectancy
Item
co-morbidity with an estimated life expectancy of < 50 % at 12 months;
boolean
C0009488 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Major surgery Scheduled
Item
scheduled major surgery in the next 12 months;
boolean
C0679637 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Compliance behavior Limited
Item
inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Study Subject Participation Status | Therapeutic procedure Investigational New Drugs | Therapeutic procedure Investigational Medical Device
Item
previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days;
boolean
C2348568 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C2346570 (UMLS CUI [3,2])
Hypersensitivity Ticagrelor | Hypersensitivity clopidogrel | History of chronic use of aspirin Hemorrhage Major | Intracranial Hemorrhages | Gastrointestinal Hemorrhage
Item
known allergy against ticagrelor, or against clopidogrel, or aspirin history of major hemorrhage (intracranial, gastrointestinal, etc.);
boolean
C0020517 (UMLS CUI [1,1])
C1999375 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C2054132 (UMLS CUI [3,1])
C0019080 (UMLS CUI [3,2])
C0205164 (UMLS CUI [3,3])
C0151699 (UMLS CUI [4])
C0017181 (UMLS CUI [5])
chronic total occlusion Anterior descending branch of left coronary artery | chronic total occlusion Structure of circumflex branch of left coronary artery | chronic total occlusion Entire right coronary artery | recanalized
Item
chronic total occlusion lesion in either lad, or lcx or rca not re-canalized;
boolean
C3275069 (UMLS CUI [1,1])
C0226032 (UMLS CUI [1,2])
C3275069 (UMLS CUI [2,1])
C0226037 (UMLS CUI [2,2])
C3275069 (UMLS CUI [3,1])
C0226042 (UMLS CUI [3,2])
C0333328 (UMLS CUI [4])
Calcification Severe Needs Rotational Atherectomy
Item
severe calcification needing rotational atherectomy;
boolean
C0175895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0027552 (UMLS CUI [1,3])
C0162655 (UMLS CUI [1,4])
ST segment elevation myocardial infarction | Chest Pain
Item
patient with stemi (within 24-hour from the onset of chest pain to admission).
boolean
C1536220 (UMLS CUI [1])
C0008031 (UMLS CUI [2])

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