Patient Appropriate Percutaneous Coronary Intervention | Patient Appropriate Stenting | Patient Appropriate Emergency Coronary Artery Bypass Surgery
Item
acceptable candidate for percutaneous coronary intervention (pci),stenting, and emergency coronary artery bypass graft surgery
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C2348535 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C0013956 (UMLS CUI [3,3])
C0010055 (UMLS CUI [3,4])
Myocardial Ischemia | Stable angina | Angina, Unstable | Silent myocardial ischemia | Test Functional Positive
Item
clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
boolean
C0151744 (UMLS CUI [1])
C0340288 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0340291 (UMLS CUI [4])
C0039593 (UMLS CUI [5,1])
C0205245 (UMLS CUI [5,2])
C1514241 (UMLS CUI [5,3])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Compliance behavior Follow-up Evaluation
Item
patient agrees to comply with specified follow-up evaluations at same investigational site
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
Target Lesion Quantity | Location Coronary arteries Separate
Item
single target lesion or two target lesions located in separate coronary arteries
boolean
C2986546 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0205042 (UMLS CUI [2,2])
C0443299 (UMLS CUI [2,3])
Lesion de novo Coronary artery Native
Item
de novo lesion(s) in native coronary artery(ies)
boolean
C0221198 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0205042 (UMLS CUI [1,3])
C0302891 (UMLS CUI [1,4])
Target Lesion Length | Stent Length
Item
target lesion(s) ≤ 27 mm in length (or ≤ 35 mm for a lesion to be treated with a 38 mm length stent)
boolean
C2986546 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
C0038257 (UMLS CUI [2,1])
C1444754 (UMLS CUI [2,2])
Target vessel | Reference Vessel Diameter | Stent Length
Item
target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm, (or 3.0 to 4.2 mm for it to be treated with a 38 mm length stent)
boolean
C0449618 (UMLS CUI [1])
C1706462 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0038257 (UMLS CUI [3,1])
C1444754 (UMLS CUI [3,2])
Exclusion Criteria General | Exclusion Criteria Angiography
Item
general and angiographic exclusion criteria highlights:
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2,1])
C0002978 (UMLS CUI [2,2])
Implantation Time period | Platelet Count measurement | White Blood Cell Count procedure | Creatinine measurement, serum
Item
within 7 days of implant platelet count <100,000 cells/mm³ or >700,000 cells/mm³; wbc count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl
boolean
C0021107 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
Myocardial Infarction | Acute Q wave myocardial infarction | Increased CK-MB
Item
acute mi within 72 hrs of the index procedure (qwmi or any elevation of ck-mb > lab upper limit of normal)
boolean
C0027051 (UMLS CUI [1])
C0582803 (UMLS CUI [2])
C1834663 (UMLS CUI [3])
Percutaneous Coronary Intervention Previous Target vessel
Item
previous pci of target vessel(s) within 9 months prior to the procedure
boolean
C1532338 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0449618 (UMLS CUI [1,3])
Percutaneous Coronary Intervention Planned Blood Vessel | Percutaneous Coronary Intervention Planned Target vessel
Item
planned pci of any vessel within 30 days post-index procedure and/or planned pci of target vessel(s) within 12 months post-index procedure
boolean
C1532338 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C1532338 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0449618 (UMLS CUI [2,3])
Cerebrovascular accident | Transient Ischemic Attack
Item
history of stroke or tia within prior 6 months
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Study Subject Participation Status Primary Endpoint Incomplete | Investigational New Drugs | Investigational Medical Device | Study Subject Participation Status Interferes with End Point
Item
participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
boolean
C2348568 (UMLS CUI [1,1])
C2986535 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C2348568 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2349179 (UMLS CUI [4,3])
Antiplatelet therapy Compliance behavior Unable
Item
inability to comply with required trial antiplatelet regimen
boolean
C1096021 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Previous stent placement Target vessel
Item
previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
boolean
C2114504 (UMLS CUI [1,1])
C0449618 (UMLS CUI [1,2])
Target vessel Lesion Percent Diameter Stenosis Measurement
Item
target vessel(s) has/have other lesions w/ > 40% diameter stenosis
boolean
C0449618 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C3897965 (UMLS CUI [1,3])
Left main coronary artery disease untreated
Item
unprotected left main coronary artery disease
boolean
C1299433 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])