ID

36525

Description

Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02226900

Link

https://clinicaltrials.gov/show/NCT02226900

Keywords

Versions (1)
  1. 5/20/19 5/20/19 -
Copyright Holder

See clinicaltrials.gov

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May 20, 2019

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License

Creative Commons BY 4.0
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Eligibility Multivessel Coronary Artery Disease NCT02226900

English

Eligibility Multivessel Coronary Artery Disease NCT02226900

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
triple-vessel disease with proximal or mid lad disease with angiographic diameter stenosis > 70% by visual analysis in all three territories, requiring myocardial revascularization or triple-vessel disease with proximal or mid lad disease with angiographic diameter stenosis 50-70% by visual analysis in any territory but with invasive or non-invasive evidence of flow-limiting stenosis in all three territories, requiring myocardial revascularization
Description

Triple vessel disease | Disease Proximal Left Anterior Descending Artery | Disease Mid-Left Anterior Descending Artery | Percent Diameter Stenosis Measurement Angiography | Site Quantity Analysis Visual | Requirement Myocardial Revascularization | Stenosis Limiting Blood flow

Data type

boolean

Alias
UMLS CUI [1]
C0856738
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C3640705
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C3640698
UMLS CUI [4,1]
C3897965
UMLS CUI [4,2]
C0002978
UMLS CUI [5,1]
C1515974
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0936012
UMLS CUI [5,4]
C0234621
UMLS CUI [6,1]
C1514873
UMLS CUI [6,2]
C0027056
UMLS CUI [7,1]
C1261287
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0232338
total syntax score > 22
Description

Coronary Artery Disease Score

Data type

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0449820
lcx and rca territories estimated to be equivalently revascularized by either pci or cabg, with at least one major non-lad vessel to be treated
Description

Circumflex branch of left coronary artery Requirement Revascularization | Right coronary artery Requirement Revascularization | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery | Therapy Vessel Major Quantity | Exception LAD

Data type

boolean

Alias
UMLS CUI [1,1]
C1305727
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0581603
UMLS CUI [2,1]
C0226042
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0581603
UMLS CUI [3]
C1532338
UMLS CUI [4]
C0010055
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0005847
UMLS CUI [5,3]
C0205164
UMLS CUI [5,4]
C1265611
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1321506
clinical and anatomic eligibility for both pci and cabg as agreed to by both interventional and surgical consensus
Description

Eligibility Percutaneous Coronary Intervention | Eligibility Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C1532338
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C0010055
interventionalist determines pci appropriateness and eligibility
Description

Determination Appropriateness Percutaneous Coronary Intervention | Determination Eligibility Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0521095
UMLS CUI [1,2]
C0814634
UMLS CUI [1,3]
C1532338
UMLS CUI [2,1]
C0521095
UMLS CUI [2,2]
C1548635
UMLS CUI [2,3]
C1532338
surgeon determines surgical appropriateness and eligibility
Description

Determination Appropriateness Surgical | Determination Eligibility Surgical

Data type

boolean

Alias
UMLS CUI [1,1]
C0521095
UMLS CUI [1,2]
C0814634
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C0521095
UMLS CUI [2,2]
C1548635
UMLS CUI [2,3]
C0543467
silent ischemia, stable angina, unstable angina or recent mi
Description

Silent myocardial ischemia | Stable angina | Angina, Unstable | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0340291
UMLS CUI [2]
C0340288
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0027051
if recent mi, cardiac biomarkers must have returned to normal prior to randomization
Description

Myocardial Infarction | Biomarkers Return to Normal

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0005516
UMLS CUI [2,2]
C0332156
UMLS CUI [2,3]
C0205307
ability to sign informed consent and comply with all study procedures
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior pci or cabg at any time prior to randomization
Description

Percutaneous Coronary Intervention Previous | Coronary Artery Bypass Surgery Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0010055
UMLS CUI [2,2]
C0205156
need for any concomitant cardiac surgery other than cabg (e.g. valve surgery, aortic repair, etc.), or intent that if the patient randomizes to surgery, any cardiac surgical procedure other than isolated cabg will be performed
Description

Patient need for Cardiac Surgery procedure | Exception Coronary Artery Bypass Surgery | Operative Surgical Procedures Valve | Aorta repair

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0018821
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0010055
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C1186983
UMLS CUI [4]
C0190364
patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year
Description

Antiplatelet therapy Dual Unable | Lacking Compliance behavior Antiplatelet therapy Dual

Data type

boolean

Alias
UMLS CUI [1,1]
C1096021
UMLS CUI [1,2]
C0205173
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C1096021
UMLS CUI [2,4]
C0205173
patients requiring additional surgery (cardiac or non cardiac) within one year
Description

Requirement Cardiac Surgery procedure Additional | Requirement Operative Surgical Procedure Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0018821
UMLS CUI [1,3]
C1524062
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C1524062
the presence of any clinical or anatomical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present (i.e. the patient should not be treated by pci, but rather should be managed with cabg or medical therapy - reasons will be documented)
Description

Medical condition Percutaneous Coronary Intervention Unfavorable | Coronary Artery Bypass Surgery Recommended | Medical therapy Recommended

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1532338
UMLS CUI [1,3]
C3640815
UMLS CUI [2,1]
C0010055
UMLS CUI [2,2]
C0034866
UMLS CUI [3,1]
C0418981
UMLS CUI [3,2]
C0034866
the presence of any clinical or anatomical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present (i.e. the patient should not be treated by cabg, but rather should be managed with pci. or medical therapy - reasons will be documented)
Description

Medical condition Coronary Artery Bypass Surgery Unfavorable | Percutaneous Coronary Intervention Recommended | Medical therapy Recommended

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0010055
UMLS CUI [1,3]
C3640815
UMLS CUI [2,1]
C1532338
UMLS CUI [2,2]
C0034866
UMLS CUI [3,1]
C0418981
UMLS CUI [3,2]
C0034866
non cardiac co-morbidities with life expectancy less than 1 year
Description

Comorbidity | Exception Heart Disease | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
UMLS CUI [3]
C0023671
other investigational drug or device studies that have not reached their primary endpoint.
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Primary Endpoint failed

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4,1]
C2986535
UMLS CUI [4,2]
C0231175
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Similar models

Eligibility Multivessel Coronary Artery Disease NCT02226900

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Triple vessel disease | Disease Proximal Left Anterior Descending Artery | Disease Mid-Left Anterior Descending Artery | Percent Diameter Stenosis Measurement Angiography | Site Quantity Analysis Visual | Requirement Myocardial Revascularization | Stenosis Limiting Blood flow
Item
triple-vessel disease with proximal or mid lad disease with angiographic diameter stenosis > 70% by visual analysis in all three territories, requiring myocardial revascularization or triple-vessel disease with proximal or mid lad disease with angiographic diameter stenosis 50-70% by visual analysis in any territory but with invasive or non-invasive evidence of flow-limiting stenosis in all three territories, requiring myocardial revascularization
boolean
C0856738 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C3640705 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C3640698 (UMLS CUI [3,2])
C3897965 (UMLS CUI [4,1])
C0002978 (UMLS CUI [4,2])
C1515974 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0936012 (UMLS CUI [5,3])
C0234621 (UMLS CUI [5,4])
C1514873 (UMLS CUI [6,1])
C0027056 (UMLS CUI [6,2])
C1261287 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0232338 (UMLS CUI [7,3])
Coronary Artery Disease Score
Item
total syntax score > 22
boolean
C1956346 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Circumflex branch of left coronary artery Requirement Revascularization | Right coronary artery Requirement Revascularization | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery | Therapy Vessel Major Quantity | Exception LAD
Item
lcx and rca territories estimated to be equivalently revascularized by either pci or cabg, with at least one major non-lad vessel to be treated
boolean
C1305727 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0581603 (UMLS CUI [1,3])
C0226042 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0581603 (UMLS CUI [2,3])
C1532338 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C0087111 (UMLS CUI [5,1])
C0005847 (UMLS CUI [5,2])
C0205164 (UMLS CUI [5,3])
C1265611 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C1321506 (UMLS CUI [6,2])
Eligibility Percutaneous Coronary Intervention | Eligibility Coronary Artery Bypass Surgery
Item
clinical and anatomic eligibility for both pci and cabg as agreed to by both interventional and surgical consensus
boolean
C1548635 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C1548635 (UMLS CUI [2,1])
C0010055 (UMLS CUI [2,2])
Determination Appropriateness Percutaneous Coronary Intervention | Determination Eligibility Percutaneous Coronary Intervention
Item
interventionalist determines pci appropriateness and eligibility
boolean
C0521095 (UMLS CUI [1,1])
C0814634 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0521095 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C1532338 (UMLS CUI [2,3])
Determination Appropriateness Surgical | Determination Eligibility Surgical
Item
surgeon determines surgical appropriateness and eligibility
boolean
C0521095 (UMLS CUI [1,1])
C0814634 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0521095 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
Silent myocardial ischemia | Stable angina | Angina, Unstable | Myocardial Infarction
Item
silent ischemia, stable angina, unstable angina or recent mi
boolean
C0340291 (UMLS CUI [1])
C0340288 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Myocardial Infarction | Biomarkers Return to Normal
Item
if recent mi, cardiac biomarkers must have returned to normal prior to randomization
boolean
C0027051 (UMLS CUI [1])
C0005516 (UMLS CUI [2,1])
C0332156 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
Informed Consent | Protocol Compliance
Item
ability to sign informed consent and comply with all study procedures
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Percutaneous Coronary Intervention Previous | Coronary Artery Bypass Surgery Previous
Item
prior pci or cabg at any time prior to randomization
boolean
C1532338 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0010055 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Patient need for Cardiac Surgery procedure | Exception Coronary Artery Bypass Surgery | Operative Surgical Procedures Valve | Aorta repair
Item
need for any concomitant cardiac surgery other than cabg (e.g. valve surgery, aortic repair, etc.), or intent that if the patient randomizes to surgery, any cardiac surgical procedure other than isolated cabg will be performed
boolean
C0686904 (UMLS CUI [1,1])
C0018821 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0010055 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C1186983 (UMLS CUI [3,2])
C0190364 (UMLS CUI [4])
Antiplatelet therapy Dual Unable | Lacking Compliance behavior Antiplatelet therapy Dual
Item
patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year
boolean
C1096021 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C1096021 (UMLS CUI [2,3])
C0205173 (UMLS CUI [2,4])
Requirement Cardiac Surgery procedure Additional | Requirement Operative Surgical Procedure Additional
Item
patients requiring additional surgery (cardiac or non cardiac) within one year
boolean
C1514873 (UMLS CUI [1,1])
C0018821 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C1524062 (UMLS CUI [2,3])
Medical condition Percutaneous Coronary Intervention Unfavorable | Coronary Artery Bypass Surgery Recommended | Medical therapy Recommended
Item
the presence of any clinical or anatomical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present (i.e. the patient should not be treated by pci, but rather should be managed with cabg or medical therapy - reasons will be documented)
boolean
C3843040 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0010055 (UMLS CUI [2,1])
C0034866 (UMLS CUI [2,2])
C0418981 (UMLS CUI [3,1])
C0034866 (UMLS CUI [3,2])
Medical condition Coronary Artery Bypass Surgery Unfavorable | Percutaneous Coronary Intervention Recommended | Medical therapy Recommended
Item
the presence of any clinical or anatomical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present (i.e. the patient should not be treated by cabg, but rather should be managed with pci. or medical therapy - reasons will be documented)
boolean
C3843040 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C1532338 (UMLS CUI [2,1])
C0034866 (UMLS CUI [2,2])
C0418981 (UMLS CUI [3,1])
C0034866 (UMLS CUI [3,2])
Comorbidity | Exception Heart Disease | Life Expectancy
Item
non cardiac co-morbidities with life expectancy less than 1 year
boolean
C0009488 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Primary Endpoint failed
Item
other investigational drug or device studies that have not reached their primary endpoint.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C2986535 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
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