ID

28794

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01021930

Nyckelord

Versioner (1)
  1. 2018-02-04 2018-02-04 -
Rättsinnehavare

See clinicaltrials.gov

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4 februari 2018

DOI

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Creative Commons BY 4.0
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Eligibility Coronary Heart Disease NCT01021930

Engelsk

Eligibility Coronary Heart Disease NCT01021930

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
general inclusion criteria：
Beskrivning

Inclusion criteria General

Datatyp

boolean

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

Age

Datatyp

boolean

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

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

Datatyp

boolean

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

Inclusion criteria Angiography

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Target Lesion de novo | Therapeutic procedure Stent Quantity

Datatyp

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.
Beskrivning

Reference Vessel Diameter Size

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
general exclusion criteria：
Beskrivning

Exclusion Criteria General

Datatyp

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.
Beskrivning

ST segment elevation myocardial infarction

Datatyp

boolean

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

Life Expectancy Due to Other medical condition

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Serum creatinine raised | End stage renal disease

Datatyp

boolean

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

Liver Dysfunction Severe

Datatyp

boolean

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

Operative Surgical Procedure Planned

Datatyp

boolean

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

Hypersensitivity Stainless Steel

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Patient Inappropriate OCT Evaluation

Datatyp

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：
Beskrivning

Exclusion Criteria Angiography

Datatyp

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).
Beskrivning

Lesion Location Ostium | Lesion Distance Vessel origin

Datatyp

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.
Beskrivning

Lesion Involving Tortuous coronary artery | Segment Arterial Tortuous High

Datatyp

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).
Beskrivning

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

Datatyp

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