ID

44480

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00741416

Nyckelord

Versioner (2)
  1. 2018-01-19 2018-01-19 -
  2. 2021-09-27 2021-09-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 september 2021

DOI

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Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00741416

Engelsk

Eligibility Coronary Artery Disease NCT00741416

1 Formulär  
Inclusion Criteria
Beskrivning

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:
Beskrivning

Patient Recruitment | CAD Group

Datatyp

boolean

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

Angioplasty | Placement of stent

Datatyp

boolean

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

Coronary Artery Bypass Surgery

Datatyp

boolean

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

Occlusion Percent Angiogram | Occlusion Percent CARDIAC CATHETERIZATION RESULT Positive

Datatyp

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
Beskrivning

Exclusion Criteria

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

Study Subject Control Group Exclusion Criteria

Datatyp

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
Beskrivning

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

Datatyp

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)
Beskrivning

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

Datatyp

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)
Beskrivning

Hypertensive disease | Blood pressure measurement Quantity

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Pharmaceutical Preparations Associated with Exclusion Criteria

Datatyp

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)
Beskrivning

Cerebrovascular accident | Transient Ischemic Attack

Datatyp

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:
Beskrivning

Exclusion Criteria CAD Group | Exclusion Criteria Control Group

Datatyp

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
Beskrivning

Hepatitis B

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
hepatitis c
Beskrivning

Hepatitis C

Datatyp

boolean

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

AIDS | HIV Seropositivity

Datatyp

boolean

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

Tuberculosis

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Bone Marrow Transplantation | Exception Autologous bone marrow transplant

Datatyp

boolean

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

Blood Transfusion

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Follow-up Unwilling

Datatyp

boolean

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

Eligibility Coronary Artery Disease NCT00741416

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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