Eligibility Coronary Artery Disease NCT00233779

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StudyEvent: Eligibility
1. Eligibility Coronary Artery Disease NCT00233779

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age

Item

1. the patient must be minimum 18 years of age;

boolean

C0001779 (UMLS CUI [1])

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

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-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 Diameter Stenosis Visual estimation | Stent dissection of coronary artery

Item

3 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 vessels 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])
C1301886 (UMLS CUI [2,2])
C0678234 (UMLS CUI [2,3])
C0444684 (UMLS CUI [2,4])
C0038257 (UMLS CUI [3,1])
C0340648 (UMLS CUI [3,2])

Target Lesion Diameter Visual estimation

Item

4. the target lesion is >/=2.0 mm and </=2.5mm in diameter (visual estimate);

boolean

C2986546 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0444684 (UMLS CUI [1,3])

Target Lesion Covered Stent

Item

5. the target lesion can be covered with a single 18mm stent;

boolean

C2986546 (UMLS CUI [1,1])
C1999244 (UMLS CUI [1,2])
C0038257 (UMLS CUI [1,3])

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

Item

6. 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])

Exclusion Criteria

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 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])

Target Lesion Due to In-stent coronary artery restenosis

Item

2. target lesion is due to in-stent restenosis;

boolean

C2986546 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1868718 (UMLS CUI [1,3])

Cardiac ejection fraction

Item

3. ejection fraction 30%;

boolean

C0232174 (UMLS CUI [1])

vessels; occlusion Total | TIMI grade 0: no perfusion

Item

4. totally occluded vessel (timi 0 level);

boolean

C1386685 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C1299341 (UMLS CUI [2])

Renal Insufficiency | Creatinine measurement, serum

Item

5. impaired renal function (creatinine > 3.0 mg/dl);

boolean

C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])

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Eligibility Coronary Artery Disease NCT00233779