ID

21791

Descripción

Dose Finding Study of PB127 Ultrasound Contrast Agent in Healthy Volunteers and Patients With Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00584818

Link

https://clinicaltrials.gov/show/NCT00584818

Palabras clave

Versiones (1)
  1. 30/4/17 30/4/17 -
Subido en

30 de abril de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Healthy NCT00584818

Inglés

Eligibility Healthy NCT00584818

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Healthy NCT00584818
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
stages 1 and 2
Descripción

clinical trial phase

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0282459
UMLS CUI [2]
C1096779
1. men and women
Descripción

gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
2. ages 18 30
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
3. normal volunteers
Descripción

volunteers

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680274
4. no history (or suspicion) of cad
Descripción

coronary artery disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1956346
stage 3
Descripción

clinical trial phase 3

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1096780
1. men and women with known or suspected cad
Descripción

coronary artery disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1956346
2. ages 18 years and older
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
3. scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following study day 1
Descripción

clinically indicated coronary angiography

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085532
UMLS CUI [1,2]
C1444656
1. coronary angiography within 28 days prior to study day 1 and/or spect must have been non-interventional
Descripción

diagnostic coronary angiography, spect

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085532
UMLS CUI [2]
C0183126
2. coronary angiography images available in digital format (non cine) for transmission to core laboratory
Descripción

coronary angiography digital images

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085532
UMLS CUI [1,2]
C1322781
4. scheduled for or undergone spect within 28 days prior to or following study day 1
Descripción

SPECT

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0183126
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. unable to provide written informed consent
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
2. women who are pregnant or lactating
Descripción

pregnancy, breast feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. known hypersensitivity or known contraindication to:
Descripción

hypersensitivity or contraindication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C1301624
1. dipyridamole
Descripción

dipyridamole contraindication

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0012582
2. ultrasound contrast agents (including pb127 and excipients)
Descripción

ultrasound contrast agent contraindication

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2917331
UMLS CUI [1,2]
C1301624
3. blood, blood products, albumin, egg whites, or protein
Descripción

blood product, albumin or protein contraindication

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C1301624
UMLS CUI [2,1]
C0001924
UMLS CUI [2,2]
C1301624
UMLS CUI [3,1]
C0033684
UMLS CUI [3,2]
C1301624
4. use of caffeine or xanthine containing products within the 24 hours prior to pb127 administration on study day 1 (stages 2 and 3)
Descripción

caffeine, xanthine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006644
UMLS CUI [2]
C0043314
5. previous exposure to pb127
Descripción

pb127 exposure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009924
UMLS CUI [1,2]
C0023175
UMLS CUI [1,3]
C0332157
6. inadequate echocardiographic windows
Descripción

inadequate echocardiographic windows

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013516
7. heart transplant
Descripción

heart transplant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018823
8. known right to left shunt, including atrial septal defect
Descripción

right to left shunt, atrial septal defect

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0428871
UMLS CUI [1,2]
C0018817
9. history of cabg
Descripción

cabg

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0010055
10. current uncontrolled ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
Descripción

ventricular tachycardia, atrial fibrillation, atrial tachycardia, atrial flutter

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042514
UMLS CUI [2]
C0004238
UMLS CUI [3]
C0546959
UMLS CUI [4]
C0004239
11. pacemaker or defibrillator
Descripción

pacemaker or defibrillator

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0180307
12. unstable angina grade ccs class iv severity with ongoing symptoms and/or ongoing infusion of iv nitroglycerin
Descripción

unstable angina ccs class grade, symptomatic, iv nitroglycerin infusion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0002965
UMLS CUI [1,2]
C1879987
UMLS CUI [1,3]
C0231220
UMLS CUI [1,4]
C0017887
UMLS CUI [1,5]
C0021440
13. second degree or greater heart block
Descripción

heart block

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018794
14. hypertension (spb >200 and/or dbp >110 mmhg on two consecutive readings within 1 hour prior to pb127 administration)
Descripción

hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020538
15. hypotension (spb <90 mmhg on two consecutive readings within 1 hour prior to pb127 administration)
Descripción

hypotension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020649
16. severe aortic stenosis (>100 mmhg peak transvalvar gradient or <0.6 cm2 estimated valve area)
Descripción

aortic stenosis, transvalvular pressure gradient, aortic valve area

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003507
UMLS CUI [1,2]
C3854450
UMLS CUI [1,3]
C0428817
17. pulmonary edema within the 7 days prior to study day 1
Descripción

pulmonary edema

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0034063
18. resting oxygen saturation of less than 90%
Descripción

resting oxygen saturation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0523807
UMLS CUI [1,2]
C0035253
19. q wave mi or major surgery within the 7 days prior to study day 1
Descripción

q wave surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1305738
UMLS CUI [1,2]
C0543467
20. ptca within the 28 days prior to study day 1
Descripción

ptca

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2936173
21. chronic obstructive pulmonary disease or bronchospastic airway disease which, in the opinion of the investigator, is significant enough to contraindicate dipyridamole
Descripción

dipyridamole contraindication, copd, bronchospasm

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012582
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0024117
UMLS CUI [1,4]
C0006266
22. known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmhg
Descripción

pulmonary hypertension, pulmonary artery systolic pressure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0428643
23. liver disease, characterized by or including one or more of the following
Descripción

liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
1. elevated total bilirubin > upper limit of normal
Descripción

bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
2. currently elevated hepatic enzymes >3x upper limit of normal
Descripción

liver enzymes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1287351
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
Descripción

medical condition

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1699700
UMLS CUI [2]
C0012634
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Similar models

Eligibility Healthy NCT00584818

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Healthy NCT00584818
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
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])
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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