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ID

28794

Description

Comparison of Diabetes Mellitus and Non-diabetes Mellitus Patients for DES Surface COVERage by OCT; ODM derived from: https://clinicaltrials.gov/show/NCT01021930

Link

https://clinicaltrials.gov/show/NCT01021930

Keywords

Versions (1)
  1. 2/4/18 2/4/18 -
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See clinicaltrials.gov

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February 4, 2018

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Creative Commons BY 4.0
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    Eligibility Coronary Heart Disease NCT01021930

    English

    Eligibility Coronary Heart Disease NCT01021930

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    general inclusion criteria：
    Description

    Inclusion criteria General

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0205246
    1. age : 18-75y
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. patients diagnosed as type 2 dm or non-dm.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011860
    UMLS CUI [2,1]
    C0011849
    UMLS CUI [2,2]
    C0332197
    angiographic inclusion criteria：
    Description

    Inclusion criteria Angiography

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0002978
    1. patients were considered eligible if they have two significant (>70%) angiographic stenosis lesions in different native coronary vessels by cag.
    Description

    Stenosis Lesion Percentage Angiography | Lesion Quantity Coronary angiography | Location Coronary Vessels Native Different

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1261287
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [1,3]
    C0439165
    UMLS CUI [1,4]
    C0002978
    UMLS CUI [2,1]
    C0221198
    UMLS CUI [2,2]
    C1265611
    UMLS CUI [2,3]
    C0085532
    UMLS CUI [3,1]
    C1515974
    UMLS CUI [3,2]
    C0010075
    UMLS CUI [3,3]
    C0302891
    UMLS CUI [3,4]
    C1705242
    2. each target is de novo lesion that can be treated with 1-2 stents.
    Description

    Target Lesion de novo | Therapeutic procedure Stent Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2986546
    UMLS CUI [1,2]
    C1515568
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0038257
    UMLS CUI [2,3]
    C1265611
    3. reference vessel diameter of 2.5 to 4.0 mm.
    Description

    Reference Vessel Diameter Size

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1706462
    UMLS CUI [1,2]
    C0005847
    UMLS CUI [1,3]
    C1301886
    UMLS CUI [1,4]
    C0456389
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    general exclusion criteria：
    Description

    Exclusion Criteria General

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C0205246
    1. st-segment elevation myocardial infarction within 7 days prior to the index procedure.
    Description

    ST segment elevation myocardial infarction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1536220
    2. life expectancy <12 months due to another medical condition.
    Description

    Life Expectancy Due to Other medical condition

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023671
    UMLS CUI [1,2]
    C0678226
    UMLS CUI [1,3]
    C3843040
    3. contraindication to antiplatelet therapy or a history of hypersensitivity to sirolimus and paclitaxel or structurally related compounds.
    Description

    Medical contraindication Antiplatelet therapy | Hypersensitivity Sirolimus | Hypersensitivity Paclitaxel | Hypersensitivity Compound Structural Related

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C1096021
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0072980
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0144576
    UMLS CUI [4,1]
    C0020517
    UMLS CUI [4,2]
    C1706082
    UMLS CUI [4,3]
    C0678594
    UMLS CUI [4,4]
    C0439849
    4. creatinine level more than 2.0mg/dl or esrd.
    Description

    Serum creatinine raised | End stage renal disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0700225
    UMLS CUI [2]
    C0022661
    5. severe hepatic dysfunction (more than 3 times normal reference values).
    Description

    Liver Dysfunction Severe

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0086565
    UMLS CUI [1,2]
    C0205082
    6. planned surgery procedure≤12 months post-index procedure.
    Description

    Operative Surgical Procedure Planned

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0543467
    UMLS CUI [1,2]
    C1301732
    7. known allergy to stainless steel.
    Description

    Hypersensitivity Stainless Steel

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0038126
    8. female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 12 months post index procedure.
    Description

    Childbearing Potential Pregnancy test positive | Breast Feeding | Pregnancy, Planned

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0240802
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C0032992
    9. patient is not clinically appropriate for oct evaluation in the opinion of investigator.
    Description

    Patient Inappropriate OCT Evaluation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1548788
    UMLS CUI [1,3]
    C0920367
    UMLS CUI [1,4]
    C1261322
    angiographic exclusion criteria：
    Description

    Exclusion Criteria Angiography

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C0002978
    1. study lesion is ostial in location (within 3.0 mm of vessel origin).
    Description

    Lesion Location Ostium | Lesion Distance Vessel origin

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1515974
    UMLS CUI [1,3]
    C0444567
    UMLS CUI [2,1]
    C0221198
    UMLS CUI [2,2]
    C0012751
    UMLS CUI [2,3]
    C1301415
    2. study lesion involving arterial segments with highly tortuous anatomy.
    Description

    Lesion Involving Tortuous coronary artery | Segment Arterial Tortuous High

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1314939
    UMLS CUI [1,3]
    C1272586
    UMLS CUI [2,1]
    C0441635
    UMLS CUI [2,2]
    C0221464
    UMLS CUI [2,3]
    C4068863
    UMLS CUI [2,4]
    C0205250
    3. complex lesion morphologies (bifurcation needs two stents technique, left main lesion, chronic obstructive occlusion, severe thrombus, heavy calcification).
    Description

    Lesion Morphology Complex | Bifurcation Needs Stent Double | Left main coronary artery Lesion | Occlusion Obstructive chronic | Severe thrombus | Calcification Severe

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0543482
    UMLS CUI [1,3]
    C0439855
    UMLS CUI [2,1]
    C3146289
    UMLS CUI [2,2]
    C0027552
    UMLS CUI [2,3]
    C0038257
    UMLS CUI [2,4]
    C0205173
    UMLS CUI [3,1]
    C1261082
    UMLS CUI [3,2]
    C0221198
    UMLS CUI [4,1]
    C1947917
    UMLS CUI [4,2]
    C0549186
    UMLS CUI [4,3]
    C0205191
    UMLS CUI [5]
    C1298827
    UMLS CUI [6,1]
    C0175895
    UMLS CUI [6,2]
    C0205082
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    Similar models

    Eligibility Coronary Heart Disease NCT01021930

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Inclusion criteria General
    Item
    general inclusion criteria：
    boolean
    C1512693 (UMLS CUI [1,1])
    C0205246 (UMLS CUI [1,2])
    Age
    Item
    1. age : 18-75y
    boolean
    C0001779 (UMLS CUI [1])
    Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus Absent
    Item
    2. patients diagnosed as type 2 dm or non-dm.
    boolean
    C0011860 (UMLS CUI [1])
    C0011849 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    Inclusion criteria Angiography
    Item
    angiographic inclusion criteria：
    boolean
    C1512693 (UMLS CUI [1,1])
    C0002978 (UMLS CUI [1,2])
    Stenosis Lesion Percentage Angiography | Lesion Quantity Coronary angiography | Location Coronary Vessels Native Different
    Item
    1. patients were considered eligible if they have two significant (>70%) angiographic stenosis lesions in different native coronary vessels by cag.
    boolean
    C1261287 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C0439165 (UMLS CUI [1,3])
    C0002978 (UMLS CUI [1,4])
    C0221198 (UMLS CUI [2,1])
    C1265611 (UMLS CUI [2,2])
    C0085532 (UMLS CUI [2,3])
    C1515974 (UMLS CUI [3,1])
    C0010075 (UMLS CUI [3,2])
    C0302891 (UMLS CUI [3,3])
    C1705242 (UMLS CUI [3,4])
    Target Lesion de novo | Therapeutic procedure Stent Quantity
    Item
    2. each target is de novo lesion that can be treated with 1-2 stents.
    boolean
    C2986546 (UMLS CUI [1,1])
    C1515568 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C0038257 (UMLS CUI [2,2])
    C1265611 (UMLS CUI [2,3])
    Reference Vessel Diameter Size
    Item
    3. reference vessel diameter of 2.5 to 4.0 mm.
    boolean
    C1706462 (UMLS CUI [1,1])
    C0005847 (UMLS CUI [1,2])
    C1301886 (UMLS CUI [1,3])
    C0456389 (UMLS CUI [1,4])
    Item Group
    C0680251 (UMLS CUI)
    Exclusion Criteria General
    Item
    general exclusion criteria：
    boolean
    C0680251 (UMLS CUI [1,1])
    C0205246 (UMLS CUI [1,2])
    ST segment elevation myocardial infarction
    Item
    1. st-segment elevation myocardial infarction within 7 days prior to the index procedure.
    boolean
    C1536220 (UMLS CUI [1])
    Life Expectancy Due to Other medical condition
    Item
    2. life expectancy <12 months due to another medical condition.
    boolean
    C0023671 (UMLS CUI [1,1])
    C0678226 (UMLS CUI [1,2])
    C3843040 (UMLS CUI [1,3])
    Medical contraindication Antiplatelet therapy | Hypersensitivity Sirolimus | Hypersensitivity Paclitaxel | Hypersensitivity Compound Structural Related
    Item
    3. contraindication to antiplatelet therapy or a history of hypersensitivity to sirolimus and paclitaxel or structurally related compounds.
    boolean
    C1301624 (UMLS CUI [1,1])
    C1096021 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0072980 (UMLS CUI [2,2])
    C0020517 (UMLS CUI [3,1])
    C0144576 (UMLS CUI [3,2])
    C0020517 (UMLS CUI [4,1])
    C1706082 (UMLS CUI [4,2])
    C0678594 (UMLS CUI [4,3])
    C0439849 (UMLS CUI [4,4])
    Serum creatinine raised | End stage renal disease
    Item
    4. creatinine level more than 2.0mg/dl or esrd.
    boolean
    C0700225 (UMLS CUI [1])
    C0022661 (UMLS CUI [2])
    Liver Dysfunction Severe
    Item
    5. severe hepatic dysfunction (more than 3 times normal reference values).
    boolean
    C0086565 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    Operative Surgical Procedure Planned
    Item
    6. planned surgery procedure≤12 months post-index procedure.
    boolean
    C0543467 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    Hypersensitivity Stainless Steel
    Item
    7. known allergy to stainless steel.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0038126 (UMLS CUI [1,2])
    Childbearing Potential Pregnancy test positive | Breast Feeding | Pregnancy, Planned
    Item
    8. female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 12 months post index procedure.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0240802 (UMLS CUI [1,2])
    C0006147 (UMLS CUI [2])
    C0032992 (UMLS CUI [3])
    Patient Inappropriate OCT Evaluation
    Item
    9. patient is not clinically appropriate for oct evaluation in the opinion of investigator.
    boolean
    C0030705 (UMLS CUI [1,1])
    C1548788 (UMLS CUI [1,2])
    C0920367 (UMLS CUI [1,3])
    C1261322 (UMLS CUI [1,4])
    Exclusion Criteria Angiography
    Item
    angiographic exclusion criteria：
    boolean
    C0680251 (UMLS CUI [1,1])
    C0002978 (UMLS CUI [1,2])
    Lesion Location Ostium | Lesion Distance Vessel origin
    Item
    1. study lesion is ostial in location (within 3.0 mm of vessel origin).
    boolean
    C0221198 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    C0444567 (UMLS CUI [1,3])
    C0221198 (UMLS CUI [2,1])
    C0012751 (UMLS CUI [2,2])
    C1301415 (UMLS CUI [2,3])
    Lesion Involving Tortuous coronary artery | Segment Arterial Tortuous High
    Item
    2. study lesion involving arterial segments with highly tortuous anatomy.
    boolean
    C0221198 (UMLS CUI [1,1])
    C1314939 (UMLS CUI [1,2])
    C1272586 (UMLS CUI [1,3])
    C0441635 (UMLS CUI [2,1])
    C0221464 (UMLS CUI [2,2])
    C4068863 (UMLS CUI [2,3])
    C0205250 (UMLS CUI [2,4])
    Lesion Morphology Complex | Bifurcation Needs Stent Double | Left main coronary artery Lesion | Occlusion Obstructive chronic | Severe thrombus | Calcification Severe
    Item
    3. complex lesion morphologies (bifurcation needs two stents technique, left main lesion, chronic obstructive occlusion, severe thrombus, heavy calcification).
    boolean
    C0221198 (UMLS CUI [1,1])
    C0543482 (UMLS CUI [1,2])
    C0439855 (UMLS CUI [1,3])
    C3146289 (UMLS CUI [2,1])
    C0027552 (UMLS CUI [2,2])
    C0038257 (UMLS CUI [2,3])
    C0205173 (UMLS CUI [2,4])
    C1261082 (UMLS CUI [3,1])
    C0221198 (UMLS CUI [3,2])
    C1947917 (UMLS CUI [4,1])
    C0549186 (UMLS CUI [4,2])
    C0205191 (UMLS CUI [4,3])
    C1298827 (UMLS CUI [5])
    C0175895 (UMLS CUI [6,1])
    C0205082 (UMLS CUI [6,2])
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