ID

16893

Description

The REALITY Study - Head-to-Head Comparison Between Cypher and Taxus; ODM derived from: https://clinicaltrials.gov/show/NCT00235092

Link

https://clinicaltrials.gov/show/NCT00235092

Keywords

Versions (1)
  1. 8/12/16 8/12/16 -
Uploaded on

August 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00235092

English

Eligibility Coronary Artery Disease NCT00235092

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b&c, i-ii-iii) or patients with documented silent ischemia;
Description

Angina Pectoris | Canadian Cardiovascular Society classification of angina | Angina, Unstable | Silent myocardial ischemia

Data type

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2]
C1277207
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0340291
2. treatment of up to two de novo native coronary artery lesions in a maximum of two major coronary arteries;
Description

Therapeutic procedure Lesion de novo Coronary artery Native | Lesion Quantity Coronary artery Major Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1515568
UMLS CUI [1,4]
C0205042
UMLS CUI [1,5]
C0302891
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0205042
UMLS CUI [2,4]
C0205164
UMLS CUI [2,5]
C1265611
3. ostial lesions;
Description

Lesion Ostium

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0444567
4. bifurcations;
Description

Coronary Vessel Bifurcation Lesion

Data type

boolean

Alias
UMLS CUI [1]
C3640041
5. target vessel diameter of both lesions must be >=2.25mm and <=3.0mm in diameter (visual estimate);
Description

Lesion Both Target vessel Diameter | Visual estimation

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1706086
UMLS CUI [1,3]
C0449618
UMLS CUI [1,4]
C1301886
UMLS CUI [2]
C0444684
6. one target lesion must be at least 15 mm in length and the second lesion has to be at least 10 mm in length with no upper limit on either;
Description

Target Lesion First Length Minimum | Target Lesion second Length Minimum

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1444754
UMLS CUI [1,4]
C1524031
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C0205436
UMLS CUI [2,3]
C1444754
UMLS CUI [2,4]
C1524031
7. target lesion stenosis for both lesions is >50% and <100% (visual estimate).
Description

Lesion Both Target Lesion Stenosis Percentage | Visual estimation

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1706086
UMLS CUI [1,3]
C2986546
UMLS CUI [1,4]
C0678234
UMLS CUI [1,5]
C0439165
UMLS CUI [2]
C0444684
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck >2 times normal within the preceding 72 hours and the ck and ck-mb enzymes remain above normal at the time of treatment;
Description

Acute Q wave myocardial infarction | Non-Q wave myocardial infarction | Measurement of total creatine kinase (CK) | Creatine kinase (cardiac enzyme) level | CK-MB in whole blood

Data type

boolean

Alias
UMLS CUI [1]
C0582803
UMLS CUI [2]
C0542269
UMLS CUI [3]
C3525717
UMLS CUI [4]
C3516327
UMLS CUI [5]
C4029718
2. has unstable angina classified as braunwald a i-ii-iii;
Description

Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0002965
3. any of the lesions is an unprotected left main coronary disease with >=50% stenosis;
Description

Lesion Any Left main coronary artery disease Stenosis Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1552551
UMLS CUI [1,3]
C1299433
UMLS CUI [1,4]
C0678234
UMLS CUI [1,5]
C0439165
4. angiographic evidence of thrombus within target lesion;
Description

Thrombus Within Target Lesion Evidence of | angiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0087086
UMLS CUI [1,2]
C0332285
UMLS CUI [1,3]
C2986546
UMLS CUI [1,4]
C0332120
UMLS CUI [2]
C0002978
5. heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated (applies to both lesions);
Description

Lesion Calcified Severe | Lesion Calcified Dilatation Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0175895
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0175895
UMLS CUI [2,3]
C1322279
UMLS CUI [2,4]
C1272705
6. documented left ventricular ejection fraction <=25%;
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
8. totally occluded vessel (timi 0 level) (applies to both lesions);
Description

vessel occlusion Total | TIMI grade 0: no perfusion

Data type

boolean

Alias
UMLS CUI [1,1]
C1386685
UMLS CUI [1,2]
C0439810
UMLS CUI [2]
C1299341
9. prior stent within 10mm of target lesion (applies to both lesions).
Description

Stent Within Target Lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0038257
UMLS CUI [1,2]
C0332285
UMLS CUI [1,3]
C2986546
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Similar models

Eligibility Coronary Artery Disease NCT00235092

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Angina Pectoris | Canadian Cardiovascular Society classification of angina | Angina, Unstable | Silent myocardial ischemia
Item
1. diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b&c, i-ii-iii) or patients with documented silent ischemia;
boolean
C0002962 (UMLS CUI [1])
C1277207 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0340291 (UMLS CUI [4])
Therapeutic procedure Lesion de novo Coronary artery Native | Lesion Quantity Coronary artery Major Quantity
Item
2. treatment of up to two de novo native coronary artery lesions in a maximum of two major coronary arteries;
boolean
C0087111 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1515568 (UMLS CUI [1,3])
C0205042 (UMLS CUI [1,4])
C0302891 (UMLS CUI [1,5])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0205042 (UMLS CUI [2,3])
C0205164 (UMLS CUI [2,4])
C1265611 (UMLS CUI [2,5])
Lesion Ostium
Item
3. ostial lesions;
boolean
C0221198 (UMLS CUI [1,1])
C0444567 (UMLS CUI [1,2])
Coronary Vessel Bifurcation Lesion
Item
4. bifurcations;
boolean
C3640041 (UMLS CUI [1])
Lesion Both Target vessel Diameter | Visual estimation
Item
5. target vessel diameter of both lesions must be >=2.25mm and <=3.0mm in diameter (visual estimate);
boolean
C0221198 (UMLS CUI [1,1])
C1706086 (UMLS CUI [1,2])
C0449618 (UMLS CUI [1,3])
C1301886 (UMLS CUI [1,4])
C0444684 (UMLS CUI [2])
Target Lesion First Length Minimum | Target Lesion second Length Minimum
Item
6. one target lesion must be at least 15 mm in length and the second lesion has to be at least 10 mm in length with no upper limit on either;
boolean
C2986546 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1444754 (UMLS CUI [1,3])
C1524031 (UMLS CUI [1,4])
C2986546 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C1444754 (UMLS CUI [2,3])
C1524031 (UMLS CUI [2,4])
Lesion Both Target Lesion Stenosis Percentage | Visual estimation
Item
7. target lesion stenosis for both lesions is >50% and <100% (visual estimate).
boolean
C0221198 (UMLS CUI [1,1])
C1706086 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C0678234 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
C0444684 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Acute Q wave myocardial infarction | Non-Q wave myocardial infarction | Measurement of total creatine kinase (CK) | Creatine kinase (cardiac enzyme) level | CK-MB in whole blood
Item
1. patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck >2 times normal within the preceding 72 hours and the ck and ck-mb enzymes remain above normal at the time of treatment;
boolean
C0582803 (UMLS CUI [1])
C0542269 (UMLS CUI [2])
C3525717 (UMLS CUI [3])
C3516327 (UMLS CUI [4])
C4029718 (UMLS CUI [5])
Angina, Unstable
Item
2. has unstable angina classified as braunwald a i-ii-iii;
boolean
C0002965 (UMLS CUI [1])
Lesion Any Left main coronary artery disease Stenosis Percentage
Item
3. any of the lesions is an unprotected left main coronary disease with >=50% stenosis;
boolean
C0221198 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1299433 (UMLS CUI [1,3])
C0678234 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
Thrombus Within Target Lesion Evidence of | angiography
Item
4. angiographic evidence of thrombus within target lesion;
boolean
C0087086 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C0332120 (UMLS CUI [1,4])
C0002978 (UMLS CUI [2])
Lesion Calcified Severe | Lesion Calcified Dilatation Unsuccessful
Item
5. heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated (applies to both lesions);
boolean
C0221198 (UMLS CUI [1,1])
C0175895 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0175895 (UMLS CUI [2,2])
C1322279 (UMLS CUI [2,3])
C1272705 (UMLS CUI [2,4])
Left ventricular ejection fraction
Item
6. documented left ventricular ejection fraction <=25%;
boolean
C0428772 (UMLS CUI [1])
vessel occlusion Total | TIMI grade 0: no perfusion
Item
8. totally occluded vessel (timi 0 level) (applies to both lesions);
boolean
C1386685 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C1299341 (UMLS CUI [2])
Stent Within Target Lesion
Item
9. prior stent within 10mm of target lesion (applies to both lesions).
boolean
C0038257 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
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