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ID

44480

Description

Biorepository: Indiana Health Study; ODM derived from: https://clinicaltrials.gov/show/NCT00741416

Link

https://clinicaltrials.gov/show/NCT00741416

Keywords

Versions (2)
  1. 1/19/18 1/19/18 -
  2. 9/27/21 9/27/21 -
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See clinicaltrials.gov

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September 27, 2021

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Creative Commons BY 4.0
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    Eligibility Coronary Artery Disease NCT00741416

    English

    Eligibility Coronary Artery Disease NCT00741416

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. study subjects will be recruited for the cad group based on a history confirmed by the medical record of at least one of the following:
    Description

    Patient Recruitment | CAD Group

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0242800
    UMLS CUI [2,1]
    C1956346
    UMLS CUI [2,2]
    C0441833
    angioplasty, with or without stent placement
    Description

    Angioplasty | Placement of stent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0162577
    UMLS CUI [2]
    C0522776
    coronary artery bypass graft (cabg) surgery
    Description

    Coronary Artery Bypass Surgery

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0010055
    diagnostic angiogram or positive catheterization results showing 50% occlusion or greater
    Description

    Occlusion Percent Angiogram | Occlusion Percent CARDIAC CATHETERIZATION RESULT Positive

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1947917
    UMLS CUI [1,2]
    C0439165
    UMLS CUI [1,3]
    C0002978
    UMLS CUI [2,1]
    C1947917
    UMLS CUI [2,2]
    C0439165
    UMLS CUI [2,3]
    C0741911
    UMLS CUI [2,4]
    C1514241
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. study subjects for the control group will be excluded based on a confirmed history of:
    Description

    Study Subject Control Group Exclusion Criteria

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0681850
    UMLS CUI [1,2]
    C0009932
    UMLS CUI [1,3]
    C0680251
    cad as defined above, or as history of a positive stress test for ischemia, troponin > 0.5 or myocardial infarction
    Description

    Coronary Artery Disease | Stress Test Positive Ischemia | Troponin measurement | Myocardial Infarction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1956346
    UMLS CUI [2,1]
    C3494508
    UMLS CUI [2,2]
    C1514241
    UMLS CUI [2,3]
    C0022116
    UMLS CUI [3]
    C0523952
    UMLS CUI [4]
    C0027051
    diabetes (type 1 or 2)
    Description

    Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011854
    UMLS CUI [2]
    C0011860
    hypertension (confirmed with at least two documented measurements of blood pressure greater than 140/90, not attributed to treating medications)
    Description

    Hypertensive disease | Blood pressure measurement Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0020538
    UMLS CUI [2,1]
    C0005824
    UMLS CUI [2,2]
    C1265611
    abnormal lipid profile defined as ldl-c < 130mg/dl, hdl ≥ 40 mg/dl, cholesterol < 240 mg/dl or triglycerides < 200 mg/dl
    Description

    Abnormal lipid profile | Low density lipoprotein cholesterol measurement | High density lipoprotein measurement | Cholesterol measurement test | Triglycerides measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0740400
    UMLS CUI [2]
    C0202117
    UMLS CUI [3]
    C0392885
    UMLS CUI [4]
    C0201950
    UMLS CUI [5]
    C0202236
    patients taking any medications commonly used for the above excluded conditions
    Description

    Pharmaceutical Preparations Associated with Exclusion Criteria

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0332281
    UMLS CUI [1,3]
    C0680251
    history of stroke or transient ischemic attacks (tias)
    Description

    Cerebrovascular accident | Transient Ischemic Attack

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038454
    UMLS CUI [2]
    C0007787
    2. exclusion criteria for both the cad group and the control group will be a known or reported history of:
    Description

    Exclusion Criteria CAD Group | Exclusion Criteria Control Group

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C1956346
    UMLS CUI [1,3]
    C0441833
    UMLS CUI [2,1]
    C0680251
    UMLS CUI [2,2]
    C0009932
    hepatitis b
    Description

    Hepatitis B

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019163
    hepatitis c
    Description

    Hepatitis C

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019196
    aids (hiv positive)
    Description

    AIDS | HIV Seropositivity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001175
    UMLS CUI [2]
    C0019699
    tuberculosis
    Description

    Tuberculosis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0041296
    cancer (including melanoma, but excluding low-malignancy skin cancer)
    Description

    Malignant Neoplasms | Melanoma | Exception Skin carcinoma Low Grade Malignant Neoplasm

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C0025202
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0699893
    UMLS CUI [3,3]
    C1334425
    non-autologous bone marrow transplant
    Description

    Bone Marrow Transplantation | Exception Autologous bone marrow transplant

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005961
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0194037
    blood transfusion within 120 days
    Description

    Blood Transfusion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005841
    3. in addition, prisoners, minors, patients requiring the consent of a caregiver or authorized representative, and/or any subjects deemed medically unsuitable for research donation by their treating physician (for reasons such as anemia, hematopoetic disorders/cancers or low body weight) will be excluded from the study.
    Description

    Prisoners | Minors | Consent Caregiver Patient need for | Consent Representative Patient need for | Patients Medical Inappropriate | Anemia | Hematological Disease | Hematopoietic Neoplasms | Underweight

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0033167
    UMLS CUI [2]
    C0026193
    UMLS CUI [3,1]
    C1511481
    UMLS CUI [3,2]
    C0085537
    UMLS CUI [3,3]
    C0686904
    UMLS CUI [4,1]
    C1511481
    UMLS CUI [4,2]
    C0030701
    UMLS CUI [4,3]
    C0686904
    UMLS CUI [5,1]
    C0030705
    UMLS CUI [5,2]
    C0205476
    UMLS CUI [5,3]
    C1548788
    UMLS CUI [6]
    C0002871
    UMLS CUI [7]
    C0018939
    UMLS CUI [8]
    C0376544
    UMLS CUI [9]
    C0041667
    4. subjects unwilling to consent to the allowance of future follow-up will be excluded from initial participation.
    Description

    Follow-up Unwilling

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3274571
    UMLS CUI [1,2]
    C0558080
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    Similar models

    Eligibility Coronary Artery Disease NCT00741416

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Patient Recruitment | CAD Group
    Item
    1. study subjects will be recruited for the cad group based on a history confirmed by the medical record of at least one of the following:
    boolean
    C0242800 (UMLS CUI [1])
    C1956346 (UMLS CUI [2,1])
    C0441833 (UMLS CUI [2,2])
    Angioplasty | Placement of stent
    Item
    angioplasty, with or without stent placement
    boolean
    C0162577 (UMLS CUI [1])
    C0522776 (UMLS CUI [2])
    Coronary Artery Bypass Surgery
    Item
    coronary artery bypass graft (cabg) surgery
    boolean
    C0010055 (UMLS CUI [1])
    Occlusion Percent Angiogram | Occlusion Percent CARDIAC CATHETERIZATION RESULT Positive
    Item
    diagnostic angiogram or positive catheterization results showing 50% occlusion or greater
    boolean
    C1947917 (UMLS CUI [1,1])
    C0439165 (UMLS CUI [1,2])
    C0002978 (UMLS CUI [1,3])
    C1947917 (UMLS CUI [2,1])
    C0439165 (UMLS CUI [2,2])
    C0741911 (UMLS CUI [2,3])
    C1514241 (UMLS CUI [2,4])
    Item Group
    C0680251 (UMLS CUI)
    Study Subject Control Group Exclusion Criteria
    Item
    1. study subjects for the control group will be excluded based on a confirmed history of:
    boolean
    C0681850 (UMLS CUI [1,1])
    C0009932 (UMLS CUI [1,2])
    C0680251 (UMLS CUI [1,3])
    Coronary Artery Disease | Stress Test Positive Ischemia | Troponin measurement | Myocardial Infarction
    Item
    cad as defined above, or as history of a positive stress test for ischemia, troponin > 0.5 or myocardial infarction
    boolean
    C1956346 (UMLS CUI [1])
    C3494508 (UMLS CUI [2,1])
    C1514241 (UMLS CUI [2,2])
    C0022116 (UMLS CUI [2,3])
    C0523952 (UMLS CUI [3])
    C0027051 (UMLS CUI [4])
    Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
    Item
    diabetes (type 1 or 2)
    boolean
    C0011854 (UMLS CUI [1])
    C0011860 (UMLS CUI [2])
    Hypertensive disease | Blood pressure measurement Quantity
    Item
    hypertension (confirmed with at least two documented measurements of blood pressure greater than 140/90, not attributed to treating medications)
    boolean
    C0020538 (UMLS CUI [1])
    C0005824 (UMLS CUI [2,1])
    C1265611 (UMLS CUI [2,2])
    Abnormal lipid profile | Low density lipoprotein cholesterol measurement | High density lipoprotein measurement | Cholesterol measurement test | Triglycerides measurement
    Item
    abnormal lipid profile defined as ldl-c < 130mg/dl, hdl ≥ 40 mg/dl, cholesterol < 240 mg/dl or triglycerides < 200 mg/dl
    boolean
    C0740400 (UMLS CUI [1])
    C0202117 (UMLS CUI [2])
    C0392885 (UMLS CUI [3])
    C0201950 (UMLS CUI [4])
    C0202236 (UMLS CUI [5])
    Pharmaceutical Preparations Associated with Exclusion Criteria
    Item
    patients taking any medications commonly used for the above excluded conditions
    boolean
    C0013227 (UMLS CUI [1,1])
    C0332281 (UMLS CUI [1,2])
    C0680251 (UMLS CUI [1,3])
    Cerebrovascular accident | Transient Ischemic Attack
    Item
    history of stroke or transient ischemic attacks (tias)
    boolean
    C0038454 (UMLS CUI [1])
    C0007787 (UMLS CUI [2])
    Exclusion Criteria CAD Group | Exclusion Criteria Control Group
    Item
    2. exclusion criteria for both the cad group and the control group will be a known or reported history of:
    boolean
    C0680251 (UMLS CUI [1,1])
    C1956346 (UMLS CUI [1,2])
    C0441833 (UMLS CUI [1,3])
    C0680251 (UMLS CUI [2,1])
    C0009932 (UMLS CUI [2,2])
    Hepatitis B
    Item
    hepatitis b
    boolean
    C0019163 (UMLS CUI [1])
    Hepatitis C
    Item
    hepatitis c
    boolean
    C0019196 (UMLS CUI [1])
    AIDS | HIV Seropositivity
    Item
    aids (hiv positive)
    boolean
    C0001175 (UMLS CUI [1])
    C0019699 (UMLS CUI [2])
    Tuberculosis
    Item
    tuberculosis
    boolean
    C0041296 (UMLS CUI [1])
    Malignant Neoplasms | Melanoma | Exception Skin carcinoma Low Grade Malignant Neoplasm
    Item
    cancer (including melanoma, but excluding low-malignancy skin cancer)
    boolean
    C0006826 (UMLS CUI [1])
    C0025202 (UMLS CUI [2])
    C1705847 (UMLS CUI [3,1])
    C0699893 (UMLS CUI [3,2])
    C1334425 (UMLS CUI [3,3])
    Bone Marrow Transplantation | Exception Autologous bone marrow transplant
    Item
    non-autologous bone marrow transplant
    boolean
    C0005961 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0194037 (UMLS CUI [2,2])
    Blood Transfusion
    Item
    blood transfusion within 120 days
    boolean
    C0005841 (UMLS CUI [1])
    Prisoners | Minors | Consent Caregiver Patient need for | Consent Representative Patient need for | Patients Medical Inappropriate | Anemia | Hematological Disease | Hematopoietic Neoplasms | Underweight
    Item
    3. in addition, prisoners, minors, patients requiring the consent of a caregiver or authorized representative, and/or any subjects deemed medically unsuitable for research donation by their treating physician (for reasons such as anemia, hematopoetic disorders/cancers or low body weight) will be excluded from the study.
    boolean
    C0033167 (UMLS CUI [1])
    C0026193 (UMLS CUI [2])
    C1511481 (UMLS CUI [3,1])
    C0085537 (UMLS CUI [3,2])
    C0686904 (UMLS CUI [3,3])
    C1511481 (UMLS CUI [4,1])
    C0030701 (UMLS CUI [4,2])
    C0686904 (UMLS CUI [4,3])
    C0030705 (UMLS CUI [5,1])
    C0205476 (UMLS CUI [5,2])
    C1548788 (UMLS CUI [5,3])
    C0002871 (UMLS CUI [6])
    C0018939 (UMLS CUI [7])
    C0376544 (UMLS CUI [8])
    C0041667 (UMLS CUI [9])
    Follow-up Unwilling
    Item
    4. subjects unwilling to consent to the allowance of future follow-up will be excluded from initial participation.
    boolean
    C3274571 (UMLS CUI [1,1])
    C0558080 (UMLS CUI [1,2])
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