ID

37191

Description

Primary Care Providers Use of a Gene Expression Test in Coronary Artery Disease Diagnosis; ODM derived from: https://clinicaltrials.gov/show/NCT01594411 This is a prospective, multi-center study examining the clinical impact of the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay in approximately 250 evaluable subjects with no history of obstructive coronary artery disease who now present with chest pain or anginal-equivalent symptoms to a primary care physician (PCP) for evaluation.

Link

https://clinicaltrials.gov/show/NCT01594411

Keywords

  1. 7/7/19 7/7/19 -
Copyright Holder

CardioDx

Uploaded on

July 7, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Gene Expression Test for Coronary Artery Disease Diagnosis NCT01594411

Eligibility Criteria

  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Does the participant have stable chest pain, typical or atypical angina or anginal equivalent?
Description

Chest Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0008031
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C1998435
UMLS CUI [3]
C0741026
UMLS CUI [4]
C0741034
Does the participant have signed the appropriate institutional review board approved informed consent form?
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C2346499
UMLS CUI [1,2]
C0009797
UMLS CUI [1,3]
C1519316
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Does the participant have a history of myocardial infarction?
Description

History of myocardial infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0027051
Does the participant have a current myocardial infarction (mi) or acute coronary syndrome?
Description

Current myocardial damage

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0027051
UMLS CUI [2]
C0948089
Does the participant have current new york heart association (nyha) class III or IV congestive heart failure symptoms?
Description

NYHA III-IV

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1536132
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1536133
Does the participant have any previous coronary revascularization?
Description

Previous coronary revascularization

Data type

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0877341
Does the particpant have diabetes, suspected unstable angina, systemic infections or systemic inflammatory conditions?
Description

Interfering diseases

Data type

boolean

Alias
UMLS CUI [1]
C0011847
UMLS CUI [2,1]
C0332147
UMLS CUI [2,2]
C0002965
UMLS CUI [3,1]
C3714514
UMLS CUI [3,2]
C0205373
UMLS CUI [4,1]
C0205373
UMLS CUI [4,2]
C0544805
Is the participant currently taking steroids, Immunosuppressive agents or chemotherapeutic agents?
Description

Interfering Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0038317
UMLS CUI [2,1]
C0521116
UMLS CUI [2,2]
C0021081
UMLS CUI [3,1]
C0521116
UMLS CUI [3,2]
C0729502
Does the participant have any major surgery within 2 months?
Description

Major Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C4018905
UMLS CUI [1,3]
C0040223

Similar models

Eligibility Criteria

  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chest Pain
Item
Does the participant have stable chest pain, typical or atypical angina or anginal equivalent?
boolean
C0008031 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1998435 (UMLS CUI [2])
C0741026 (UMLS CUI [3])
C0741034 (UMLS CUI [4])
Informed Consent
Item
Does the participant have signed the appropriate institutional review board approved informed consent form?
boolean
C2346499 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
History of myocardial infarction
Item
Does the participant have a history of myocardial infarction?
boolean
C0262926 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
Current myocardial damage
Item
Does the participant have a current myocardial infarction (mi) or acute coronary syndrome?
boolean
C0521116 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C0948089 (UMLS CUI [2])
NYHA III-IV
Item
Does the participant have current new york heart association (nyha) class III or IV congestive heart failure symptoms?
boolean
C1457887 (UMLS CUI [1,1])
C1536132 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C1536133 (UMLS CUI [2,2])
Previous coronary revascularization
Item
Does the participant have any previous coronary revascularization?
boolean
C0205156 (UMLS CUI [1,1])
C0877341 (UMLS CUI [1,2])
Interfering diseases
Item
Does the particpant have diabetes, suspected unstable angina, systemic infections or systemic inflammatory conditions?
boolean
C0011847 (UMLS CUI [1])
C0332147 (UMLS CUI [2,1])
C0002965 (UMLS CUI [2,2])
C3714514 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0205373 (UMLS CUI [4,1])
C0544805 (UMLS CUI [4,2])
Interfering Drugs
Item
Is the participant currently taking steroids, Immunosuppressive agents or chemotherapeutic agents?
boolean
C0521116 (UMLS CUI [1,1])
C0038317 (UMLS CUI [1,2])
C0521116 (UMLS CUI [2,1])
C0021081 (UMLS CUI [2,2])
C0521116 (UMLS CUI [3,1])
C0729502 (UMLS CUI [3,2])
Major Surgery
Item
Does the participant have any major surgery within 2 months?
boolean
C0679637 (UMLS CUI [1,1])
C4018905 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])

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