Eligibility Coronary Artery Disease NCT00726453

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StudyEvent: Eligibility
1. Eligibility Coronary Artery Disease NCT00726453

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Criteria

Item Group

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])

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Eligibility Coronary Artery Disease NCT00726453