ID

21531

Description

NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions; ODM derived from: https://clinicaltrials.gov/show/NCT00231283

Link

https://clinicaltrials.gov/show/NCT00231283

Keywords

Versions (1)
  1. 4/26/17 4/26/17 -
Uploaded on

April 26, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00231283

English

Eligibility Coronary Artery Disease NCT00231283

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or non-pregnant female patients 18 years of age
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. 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) or patients with documented silent ischemia;
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0340291
UMLS CUI [1,3]
C1277207
3. treatment of a single de novo target lesion in a major native coronary artery;
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205042
4. target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate);
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1,1]
C1301886
UMLS CUI [1,2]
C0221198
5. target lesion is 30mm in length (visual estimate);
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1444754
6. target lesion stenosis is > 50% and < 100% (visual estimate);
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1]
C1261287
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 24 hours and the ck and ck-mb enzymes remain above normal at the time of treatment;
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1,1]
C0542269
UMLS CUI [1,2]
C0582803
UMLS CUI [1,3]
C0201973
2. has unstable angina classified as braunwald iii b or c, or is having a peri-infarction angina;
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1]
C0002965
3. significant (> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1,1]
C1261287
UMLS CUI [1,2]
C0581603
4. documented left ventricular ejection fraction 25%;
Description

ID.10

Data type

boolean

Alias
UMLS CUI [1]
C0428772
5. totally occluded vessel (timi 0 level);
Description

ID.11

Data type

boolean

Alias
UMLS CUI [1]
C0429885
6. impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
Description

ID.12

Data type

boolean

Alias
UMLS CUI [1,1]
C0201975
UMLS CUI [1,2]
C0232807
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Similar models

Eligibility Coronary Artery Disease NCT00231283

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
1. male or non-pregnant female patients 18 years of age
boolean
C0001779 (UMLS CUI [1])
ID.2
Item
2. 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) or patients with documented silent ischemia;
boolean
C0002962 (UMLS CUI [1,1])
C0340291 (UMLS CUI [1,2])
C1277207 (UMLS CUI [1,3])
ID.3
Item
3. treatment of a single de novo target lesion in a major native coronary artery;
boolean
C0087111 (UMLS CUI [1,1])
C0205042 (UMLS CUI [1,2])
ID.4
Item
4. target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate);
boolean
C1301886 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
ID.5
Item
5. target lesion is 30mm in length (visual estimate);
boolean
C0221198 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
ID.6
Item
6. target lesion stenosis is > 50% and < 100% (visual estimate);
boolean
C1261287 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.7
Item
1. patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck > 2 times normal within the preceding 24 hours and the ck and ck-mb enzymes remain above normal at the time of treatment;
boolean
C0542269 (UMLS CUI [1,1])
C0582803 (UMLS CUI [1,2])
C0201973 (UMLS CUI [1,3])
ID.8
Item
2. has unstable angina classified as braunwald iii b or c, or is having a peri-infarction angina;
boolean
C0002965 (UMLS CUI [1])
ID.9
Item
3. significant (> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
boolean
C1261287 (UMLS CUI [1,1])
C0581603 (UMLS CUI [1,2])
ID.10
Item
4. documented left ventricular ejection fraction 25%;
boolean
C0428772 (UMLS CUI [1])
ID.11
Item
5. totally occluded vessel (timi 0 level);
boolean
C0429885 (UMLS CUI [1])
ID.12
Item
6. impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
boolean
C0201975 (UMLS CUI [1,1])
C0232807 (UMLS CUI [1,2])
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