ID

21791

Beschreibung

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

Stichworte

Versionen (1)
  1. 30.04.17 30.04.17 -
Hochgeladen am

30. April 2017

DOI

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Eligibility Healthy NCT00584818

Englisch

Eligibility Healthy NCT00584818

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Healthy NCT00584818
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
stages 1 and 2
Beschreibung

clinical trial phase

Datentyp

boolean

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

gender

Datentyp

boolean

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

age

Datentyp

boolean

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

volunteers

Datentyp

boolean

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

coronary artery disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1956346
stage 3
Beschreibung

clinical trial phase 3

Datentyp

boolean

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

coronary artery disease

Datentyp

boolean

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

age

Datentyp

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
Beschreibung

clinically indicated coronary angiography

Datentyp

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
Beschreibung

diagnostic coronary angiography, spect

Datentyp

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
Beschreibung

coronary angiography digital images

Datentyp

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
Beschreibung

SPECT

Datentyp

boolean

Alias
UMLS CUI [1]
C0183126
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

informed consent

Datentyp

boolean

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

pregnancy, breast feeding

Datentyp

boolean

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

hypersensitivity or contraindication

Datentyp

boolean

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

dipyridamole contraindication

Datentyp

boolean

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

ultrasound contrast agent contraindication

Datentyp

boolean

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

blood product, albumin or protein contraindication

Datentyp

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)
Beschreibung

caffeine, xanthine

Datentyp

boolean

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

pb127 exposure

Datentyp

boolean

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

inadequate echocardiographic windows

Datentyp

boolean

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

heart transplant

Datentyp

boolean

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

right to left shunt, atrial septal defect

Datentyp

boolean

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

cabg

Datentyp

boolean

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

ventricular tachycardia, atrial fibrillation, atrial tachycardia, atrial flutter

Datentyp

boolean

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

pacemaker or defibrillator

Datentyp

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
Beschreibung

unstable angina ccs class grade, symptomatic, iv nitroglycerin infusion

Datentyp

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
Beschreibung

heart block

Datentyp

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)
Beschreibung

hypertension

Datentyp

boolean

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

hypotension

Datentyp

boolean

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

aortic stenosis, transvalvular pressure gradient, aortic valve area

Datentyp

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
Beschreibung

pulmonary edema

Datentyp

boolean

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

resting oxygen saturation

Datentyp

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
Beschreibung

q wave surgery

Datentyp

boolean

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

ptca

Datentyp

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
Beschreibung

dipyridamole contraindication, copd, bronchospasm

Datentyp

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
Beschreibung

pulmonary hypertension, pulmonary artery systolic pressure

Datentyp

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
Beschreibung

liver disease

Datentyp

boolean

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

bilirubin

Datentyp

boolean

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

liver enzymes

Datentyp

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
Beschreibung

medical condition

Datentyp

boolean

Alias
UMLS CUI [1]
C1699700
UMLS CUI [2]
C0012634
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Ähnliche Modelle

Eligibility Healthy NCT00584818

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Healthy NCT00584818
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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