Eligibility Healthy NCT00584818

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StudyEvent: Eligibility
1. Eligibility Healthy NCT00584818

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

clinical trial phase

Item

stages 1 and 2

boolean

C0282459 (UMLS CUI [1])
C1096779 (UMLS CUI [2])

gender

Item

1. men and women

boolean

C0079399 (UMLS CUI [1])

age

Item

2. ages 18 30

boolean

C0001779 (UMLS CUI [1])

volunteers

Item

3. normal volunteers

boolean

C0680274 (UMLS CUI [1])

coronary artery disease

Item

4. no history (or suspicion) of cad

boolean

C1956346 (UMLS CUI [1])

clinical trial phase 3

Item

stage 3

boolean

C1096780 (UMLS CUI [1])

coronary artery disease

Item

1. men and women with known or suspected cad

boolean

C1956346 (UMLS CUI [1])

age

Item

2. ages 18 years and older

boolean

C0001779 (UMLS CUI [1])

clinically indicated coronary angiography

Item

3. scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following study day 1

boolean

C0085532 (UMLS CUI [1,1])
C1444656 (UMLS CUI [1,2])

diagnostic coronary angiography, spect

Item

1. coronary angiography within 28 days prior to study day 1 and/or spect must have been non-interventional

boolean

C0085532 (UMLS CUI [1])
C0183126 (UMLS CUI [2])

coronary angiography digital images

Item

2. coronary angiography images available in digital format (non cine) for transmission to core laboratory

boolean

C0085532 (UMLS CUI [1,1])
C1322781 (UMLS CUI [1,2])

SPECT

Item

4. scheduled for or undergone spect within 28 days prior to or following study day 1

boolean

C0183126 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

informed consent

Item

1. unable to provide written informed consent

boolean

C0021430 (UMLS CUI [1])

pregnancy, breast feeding

Item

2. women who are pregnant or lactating

boolean

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

hypersensitivity or contraindication

Item

3. known hypersensitivity or known contraindication to:

boolean

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

dipyridamole contraindication

Item

1. dipyridamole

boolean

C1301624 (UMLS CUI [1,1])
C0012582 (UMLS CUI [1,2])

ultrasound contrast agent contraindication

Item

2. ultrasound contrast agents (including pb127 and excipients)

boolean

C2917331 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])

blood product, albumin or protein contraindication

Item

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

boolean

C0456388 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0001924 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C0033684 (UMLS CUI [3,1])
C1301624 (UMLS CUI [3,2])

caffeine, xanthine

Item

4. use of caffeine or xanthine containing products within the 24 hours prior to pb127 administration on study day 1 (stages 2 and 3)

boolean

C0006644 (UMLS CUI [1])
C0043314 (UMLS CUI [2])

pb127 exposure

Item

5. previous exposure to pb127

boolean

C0009924 (UMLS CUI [1,1])
C0023175 (UMLS CUI [1,2])
C0332157 (UMLS CUI [1,3])

inadequate echocardiographic windows

Item

6. inadequate echocardiographic windows

boolean

C0013516 (UMLS CUI [1])

heart transplant

Item

7. heart transplant

boolean

C0018823 (UMLS CUI [1])

right to left shunt, atrial septal defect

Item

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

boolean

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

cabg

Item

9. history of cabg

boolean

C0010055 (UMLS CUI [1])

ventricular tachycardia, atrial fibrillation, atrial tachycardia, atrial flutter

Item

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

boolean

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

pacemaker or defibrillator

Item

11. pacemaker or defibrillator

boolean

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

unstable angina ccs class grade, symptomatic, iv nitroglycerin 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])
C1879987 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C0017887 (UMLS CUI [1,4])
C0021440 (UMLS CUI [1,5])

heart block

Item

13. second degree or greater heart block

boolean

C0018794 (UMLS CUI [1])

hypertension

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])

hypotension

Item

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

boolean

C0020649 (UMLS CUI [1])

aortic stenosis, transvalvular pressure gradient, aortic valve area

Item

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

boolean

C0003507 (UMLS CUI [1,1])
C3854450 (UMLS CUI [1,2])
C0428817 (UMLS CUI [1,3])

pulmonary edema

Item

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

boolean

C0034063 (UMLS CUI [1])

resting oxygen saturation

Item

18. resting oxygen saturation of less than 90%

boolean

C0523807 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])

q wave surgery

Item

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

boolean

C1305738 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])

ptca

Item

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

boolean

C2936173 (UMLS CUI [1])

dipyridamole contraindication, copd, bronchospasm

Item

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

boolean

C0012582 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
C0006266 (UMLS CUI [1,4])

pulmonary hypertension, pulmonary artery systolic pressure

Item

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

boolean

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

liver disease

Item

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

boolean

C0023895 (UMLS CUI [1])

bilirubin

Item

1. elevated total bilirubin > upper limit of normal

boolean

C1278039 (UMLS CUI [1])

liver enzymes

Item

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

boolean

C1287351 (UMLS CUI [1])

medical condition

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

C1699700 (UMLS CUI [1])
C0012634 (UMLS CUI [2])

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Eligibility Healthy NCT00584818