ID

23921

Beschrijving

Evaluation and Optimization of PB127 Myocardial Perfusion Echocardiography on Ultrasound Systems; ODM derived from: https://clinicaltrials.gov/show/NCT00487903

Link

https://clinicaltrials.gov/show/NCT00487903

Trefwoorden

Versies (1)
  1. 18-07-17 18-07-17 -
Geüploaded op

18 juli 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00487903

Engels

Eligibility Coronary Artery Disease NCT00487903

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men and women
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
1. normal volunteers (18 30 years old), with no history of cad
Beschrijving

Normal Volunteers | Age | Coronary Artery Disease Absent

Datatype

boolean

Alias
UMLS CUI [1]
C3661466
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C1956346
UMLS CUI [3,2]
C0332197
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
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1956346
UMLS CUI [3,1]
C1956346
UMLS CUI [3,2]
C0750491
UMLS CUI [4]
C0085532
UMLS CUI [5,1]
C0085532
UMLS CUI [5,2]
C0205539
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
2. women who are pregnant or lactating
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

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

Hypersensitivity | Medical contraindication

Datatype

boolean

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

Dipyridamole

Datatype

boolean

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

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

Datatype

boolean

Alias
UMLS CUI [1]
C2917331
UMLS CUI [2]
C1959382
UMLS CUI [3,1]
C1959382
UMLS CUI [3,2]
C0015237
3. blood, blood products, albumin, egg whites, or protein
Beschrijving

Blood | Blood product | Albumins | Egg White | Proteins

Datatype

boolean

Alias
UMLS CUI [1]
C0005767
UMLS CUI [2]
C0456388
UMLS CUI [3]
C0001924
UMLS CUI [4]
C0013704
UMLS CUI [5]
C0033684
4. use of caffeine or xanthine containing products within the 24 hours prior to pb127 administration on study day 1
Beschrijving

Caffeine products | Product Containing Xanthine

Datatype

boolean

Alias
UMLS CUI [1]
C0006644
UMLS CUI [2,1]
C1514468
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0043314
5. previous exposure to pb127
Beschrijving

Exposure to PB-127

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1959382
6. inadequate echocardiographic windows
Beschrijving

Echocardiography window Inadequate

Datatype

boolean

Alias
UMLS CUI [1,1]
C2040748
UMLS CUI [1,2]
C0205412
7. heart transplant
Beschrijving

Heart Transplantation

Datatype

boolean

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

Right to left cardiovascular shunt | Atrial Septal Defect

Datatype

boolean

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

Coronary Artery Bypass Surgery

Datatype

boolean

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

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042514
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0004238
UMLS CUI [3]
C0546959
UMLS CUI [4]
C0004239
11. pacemaker or defibrillator
Beschrijving

Artificial cardiac pacemaker | Defibrillators

Datatype

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
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002965
UMLS CUI [1,2]
C1277207
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0549178
UMLS CUI [3,1]
C0017887
UMLS CUI [3,2]
C0021440
13. second degree or greater heart block
Beschrijving

Second degree atrioventricular block | Complete atrioventricular block

Datatype

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
14. hypertension (spb >200 and/or dbp >110 mmhg on two consecutive readings within 1 hour prior to pb127 administration)
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0005824
UMLS CUI [4,2]
C1707491
UMLS CUI [4,3]
C1265611
15. hypotension (spb <90 mmhg on two consecutive readings within 1 hour prior to pb127 administration)
Beschrijving

Hypotension | Systolic Pressure | Blood pressure determination Consecutive Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0871470
UMLS CUI [3,1]
C0005824
UMLS CUI [3,2]
C1707491
UMLS CUI [3,3]
C1265611
16. severe aortic stenosis (>100 mmhg peak transvalvar gradient or <0.6 cm2 estimated valve area)
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C3806272
UMLS CUI [2,1]
C3854450
UMLS CUI [2,2]
C0444505
UMLS CUI [3,1]
C0428817
UMLS CUI [3,2]
C0750572
17. pulmonary edema within the 7 days prior to study day 1
Beschrijving

Pulmonary Edema

Datatype

boolean

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

Oxygen saturation At rest

Datatype

boolean

Alias
UMLS CUI [1,1]
C0523807
UMLS CUI [1,2]
C0443144
19. q wave mi within the 7 days prior to study day 1
Beschrijving

Q wave Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1,1]
C1305738
UMLS CUI [1,2]
C0027051
20. ptca within the 28 days prior to study day 1
Beschrijving

Percutaneous Transluminal Coronary Angioplasty

Datatype

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
Beschrijving

Chronic Obstructive Airway Disease | Bronchial Spasm | Medical contraindication Dipyridamole

Datatype

boolean

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

Pulmonary Hypertension Severe | Pulmonary artery systolic pressure Estimated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0428643
UMLS CUI [2,2]
C0750572
23. liver disease, characterized by or including one or more of the following
Beschrijving

Liver disease

Datatype

boolean

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

Elevated total bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C0741494
2. currently elevated hepatic enzymes >3x upper limit of normal
Beschrijving

Elevated liver enzymes

Datatype

boolean

Alias
UMLS CUI [1]
C0235996
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
Beschrijving

Medical condition Interferes with Study data | Circumstance Interferes with Study data | Medical condition Interferes with Research results | Circumstance Interferes with Research results | Drug Dependence | Mental disorders | Dementia | Associated disease | Medical condition Protocol Compliance Unlikely | Circumstance Protocol Compliance Unlikely

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0681873
UMLS CUI [2,1]
C0868647
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0681873
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C0868647
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
UMLS CUI [5]
C1510472
UMLS CUI [6]
C0004936
UMLS CUI [7]
C0497327
UMLS CUI [8]
C0243083
UMLS CUI [9,1]
C3843040
UMLS CUI [9,2]
C0525058
UMLS CUI [9,3]
C0750558
UMLS CUI [10,1]
C0868647
UMLS CUI [10,2]
C0525058
UMLS CUI [10,3]
C0750558
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Eligibility Coronary Artery Disease NCT00487903

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
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])
Medical condition Interferes with Study data | Circumstance Interferes with Study data | Medical condition Interferes with Research results | Circumstance Interferes with Research results | Drug Dependence | Mental disorders | Dementia | Associated disease | Medical condition Protocol Compliance Unlikely | Circumstance Protocol Compliance Unlikely
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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