ID

16885

Description

Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions; ODM derived from: https://clinicaltrials.gov/show/NCT00233714

Link

https://clinicaltrials.gov/show/NCT00233714

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 NCT00233714

English

Eligibility Coronary Artery Disease NCT00233714

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the patient must be minimum 18 years of age;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. patients must be previously diagnosed with diabetes with documented treatment with insulin, oral medications, or diet for a minimum of 3 months;
Description

Diabetes Mellitus | Insulin regime | Therapeutic procedure oral medication | Diet therapy

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0557978
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0175795
UMLS CUI [4]
C0012159
3. 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
4. treatment of one lesion in a native coronary artery. the treated lesion will be the one with the highest % diameter stenosis by visual estimate. additional study stents may be used for procedural complications such as dissections. multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. if other non-target lesions are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;
Description

Therapeutic procedure Lesion Coronary artery Native | Lesion Stenosis Diameter Visual estimation | Stent dissection of coronary artery

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205042
UMLS CUI [1,4]
C0302891
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0678234
UMLS CUI [2,3]
C1301886
UMLS CUI [2,4]
C0444684
UMLS CUI [3,1]
C0038257
UMLS CUI [3,2]
C0340648
5. the target vessel is 2.5 mm and 3.5mm in diameter (visual estimate);
Description

Target vessel size Diameter Visual estimation

Data type

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C1301886
UMLS CUI [1,4]
C0444684
6. the target lesion is <30 mm in length (visual estimate) located in a native coronary artery;
Description

Target Lesion Length Visual estimation | Target Lesion Location Coronary artery Native

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1444754
UMLS CUI [1,3]
C0444684
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C0450429
UMLS CUI [2,3]
C0205042
UMLS CUI [2,4]
C0302891
7. target lesion stenosis is >50% and <100% (timi i) (visual estimate);
Description

Target Lesion Stenosis Visual estimation | TIMI grade 1: penetration without perfusion

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0678234
UMLS CUI [1,3]
C0444684
UMLS CUI [2]
C1299340
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 remains 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. patients admitted for treatment of diabetic ketoacidosis > 2 times in the past six months (brittle diabetics);
Description

Therapeutic procedure Diabetic Ketoacidosis | Brittle diabetes

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0011880
UMLS CUI [2]
C0342302
3. ejection fraction 30%;
Description

Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
4. impaired renal function (creatinine > 2.0 mg/dl);
Description

Renal Insufficiency | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
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Similar models

Eligibility Coronary Artery Disease NCT00233714

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. the patient must be minimum 18 years of age;
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus | Insulin regime | Therapeutic procedure oral medication | Diet therapy
Item
2. patients must be previously diagnosed with diabetes with documented treatment with insulin, oral medications, or diet for a minimum of 3 months;
boolean
C0011849 (UMLS CUI [1])
C0557978 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0175795 (UMLS CUI [3,2])
C0012159 (UMLS CUI [4])
Angina Pectoris | Canadian Cardiovascular Society classification of angina | Angina, Unstable | Silent myocardial ischemia
Item
3. 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 Coronary artery Native | Lesion Stenosis Diameter Visual estimation | Stent dissection of coronary artery
Item
4. treatment of one lesion in a native coronary artery. the treated lesion will be the one with the highest % diameter stenosis by visual estimate. additional study stents may be used for procedural complications such as dissections. multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. if other non-target lesions are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;
boolean
C0087111 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205042 (UMLS CUI [1,3])
C0302891 (UMLS CUI [1,4])
C0221198 (UMLS CUI [2,1])
C0678234 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0444684 (UMLS CUI [2,4])
C0038257 (UMLS CUI [3,1])
C0340648 (UMLS CUI [3,2])
Target vessel size Diameter Visual estimation
Item
5. the target vessel is 2.5 mm and 3.5mm in diameter (visual estimate);
boolean
C0449618 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0444684 (UMLS CUI [1,4])
Target Lesion Length Visual estimation | Target Lesion Location Coronary artery Native
Item
6. the target lesion is <30 mm in length (visual estimate) located in a native coronary artery;
boolean
C2986546 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
C0444684 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C0450429 (UMLS CUI [2,2])
C0205042 (UMLS CUI [2,3])
C0302891 (UMLS CUI [2,4])
Target Lesion Stenosis Visual estimation | TIMI grade 1: penetration without perfusion
Item
7. target lesion stenosis is >50% and <100% (timi i) (visual estimate);
boolean
C2986546 (UMLS CUI [1,1])
C0678234 (UMLS CUI [1,2])
C0444684 (UMLS CUI [1,3])
C1299340 (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 24 hours and the ck and ck-mb enzymes remains 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])
Therapeutic procedure Diabetic Ketoacidosis | Brittle diabetes
Item
2. patients admitted for treatment of diabetic ketoacidosis > 2 times in the past six months (brittle diabetics);
boolean
C0087111 (UMLS CUI [1,1])
C0011880 (UMLS CUI [1,2])
C0342302 (UMLS CUI [2])
Cardiac ejection fraction
Item
3. ejection fraction 30%;
boolean
C0232174 (UMLS CUI [1])
Renal Insufficiency | Creatinine measurement, serum
Item
4. impaired renal function (creatinine > 2.0 mg/dl);
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
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