Eligibility Coronary Artery Disease NCT00487903

1 Formulários

StudyEvent: Eligibility
1. Eligibility Coronary Artery Disease NCT00487903

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Gender

Item

1. men and women

boolean

C0079399 (UMLS CUI [1])

Normal Volunteers | Age | Coronary Artery Disease Absent

Item

1. normal volunteers (18 30 years old), with no history of cad

boolean

C3661466 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1956346 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])

Age | Coronary Artery Disease | Coronary Artery Disease Suspected | Coronary angiography | Coronary angiography Scheduled

Item

2. patients (≥ 18 years old) with known or suspected cad, scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following study day 1

boolean

C0001779 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C1956346 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0085532 (UMLS CUI [4])
C0085532 (UMLS CUI [5,1])
C0205539 (UMLS CUI [5,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Informed Consent Unable

Item

1. unable to provide written informed consent

boolean

C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])

Pregnancy | Breast Feeding

Item

2. women who are pregnant or lactating

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Hypersensitivity | Medical contraindication

Item

3. known hypersensitivity or known contraindication to:

boolean

C0020517 (UMLS CUI [1])
C1301624 (UMLS CUI [2])

Dipyridamole

Item

1. dipyridamole

boolean

C0012582 (UMLS CUI [1])

Contrast Agent for Ultrasound Imaging | PB-127 | PB-127 Excipient

Item

2. ultrasound contrast agents (including pb127 and excipients)

boolean

C2917331 (UMLS CUI [1])
C1959382 (UMLS CUI [2])
C1959382 (UMLS CUI [3,1])
C0015237 (UMLS CUI [3,2])

Blood | Blood product | Albumins | Egg White | Proteins

Item

3. blood, blood products, albumin, egg whites, or protein

boolean

C0005767 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
C0001924 (UMLS CUI [3])
C0013704 (UMLS CUI [4])
C0033684 (UMLS CUI [5])

Caffeine products | Product Containing Xanthine

Item

4. use of caffeine or xanthine containing products within the 24 hours prior to pb127 administration on study day 1

boolean

C0006644 (UMLS CUI [1])
C1514468 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0043314 (UMLS CUI [2,3])

Exposure to PB-127

Item

5. previous exposure to pb127

boolean

C0332157 (UMLS CUI [1,1])
C1959382 (UMLS CUI [1,2])

Echocardiography window Inadequate

Item

6. inadequate echocardiographic windows

boolean

C2040748 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])

Heart Transplantation

Item

7. heart transplant

boolean

C0018823 (UMLS CUI [1])

Right to left cardiovascular shunt | Atrial Septal Defect

Item

8. known right to left shunt, including atrial septal defect

boolean

C0428871 (UMLS CUI [1])
C0018817 (UMLS CUI [2])

Coronary Artery Bypass Surgery

Item

9. history of cabg

boolean

C0010055 (UMLS CUI [1])

Ventricular Tachycardia Uncontrolled | Atrial Fibrillation | Atrial tachycardia | Atrial Flutter

Item

10. current uncontrolled ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter

boolean

C0042514 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2])
C0546959 (UMLS CUI [3])
C0004239 (UMLS CUI [4])

Artificial cardiac pacemaker | Defibrillators

Item

11. pacemaker or defibrillator

boolean

C0030163 (UMLS CUI [1])
C0180307 (UMLS CUI [2])

Unstable Angina Canadian Cardiovascular Society classification of angina | Symptoms Continuous | Nitroglycerin Intravenous infusion

Item

12. unstable angina grade ccs class iv severity with ongoing symptoms and/or ongoing infusion of iv nitroglycerin

boolean

C0002965 (UMLS CUI [1,1])
C1277207 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C0017887 (UMLS CUI [3,1])
C0021440 (UMLS CUI [3,2])

Second degree atrioventricular block | Complete atrioventricular block

Item

13. second degree or greater heart block

boolean

C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])

Hypertensive disease | Systolic Pressure | Diastolic blood pressure | Blood pressure determination Consecutive Quantity

Item

14. hypertension (spb >200 and/or dbp >110 mmhg on two consecutive readings within 1 hour prior to pb127 administration)

boolean

C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0005824 (UMLS CUI [4,1])
C1707491 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])

Hypotension | Systolic Pressure | Blood pressure determination Consecutive Quantity

Item

15. hypotension (spb <90 mmhg on two consecutive readings within 1 hour prior to pb127 administration)

boolean

C0020649 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0005824 (UMLS CUI [3,1])
C1707491 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])

Aortic stenosis, severe | Transvalvular pressure gradient Peak | Aortic valve area Estimated

Item

16. severe aortic stenosis (>100 mmhg peak transvalvar gradient or <0.6 cm2 estimated valve area)

boolean

C3806272 (UMLS CUI [1])
C3854450 (UMLS CUI [2,1])
C0444505 (UMLS CUI [2,2])
C0428817 (UMLS CUI [3,1])
C0750572 (UMLS CUI [3,2])

Pulmonary Edema

Item

17. pulmonary edema within the 7 days prior to study day 1

boolean

C0034063 (UMLS CUI [1])

Oxygen saturation At rest

Item

18. resting oxygen saturation of less than 90%

boolean

C0523807 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])

Q wave Myocardial Infarction

Item

19. q wave mi within the 7 days prior to study day 1

boolean

C1305738 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])

Percutaneous Transluminal Coronary Angioplasty

Item

20. ptca within the 28 days prior to study day 1

boolean

C2936173 (UMLS CUI [1])

Chronic Obstructive Airway Disease | Bronchial Spasm | Medical contraindication Dipyridamole

Item

21. chronic obstructive pulmonary disease or bronchospastic airway disease which, in the opinion of the investigator, is significant enough to contraindicate dipyridamole

boolean

C0024117 (UMLS CUI [1])
C0006266 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0012582 (UMLS CUI [3,2])

Pulmonary Hypertension Severe | Pulmonary artery systolic pressure Estimated

Item

22. known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmhg

boolean

C0020542 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0428643 (UMLS CUI [2,1])
C0750572 (UMLS CUI [2,2])

Liver disease

Item

23. liver disease, characterized by or including one or more of the following

boolean

C0023895 (UMLS CUI [1])

Elevated total bilirubin

Item

1. elevated total bilirubin >upper limit of normal

boolean

C0741494 (UMLS CUI [1])

Elevated liver enzymes

Item

2. currently elevated hepatic enzymes >3x upper limit of normal

boolean

C0235996 (UMLS CUI [1])

Item

24. medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives (i.e., drug dependence, psychiatric disorder, dementia, or associated illness); extenuating circumstances or medical conditions that make it unlikely that a patient can complete the clinical trial or follow up evaluations; or other reasons for expected poor compliance with the clinical investigator's instructions

boolean

C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0681873 (UMLS CUI [1,3])
C0868647 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0681873 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0868647 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
C1510472 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
C0497327 (UMLS CUI [7])
C0243083 (UMLS CUI [8])
C3843040 (UMLS CUI [9,1])
C0525058 (UMLS CUI [9,2])
C0750558 (UMLS CUI [9,3])
C0868647 (UMLS CUI [10,1])
C0525058 (UMLS CUI [10,2])
C0750558 (UMLS CUI [10,3])

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Eligibility Coronary Artery Disease NCT00487903