SPECT Scheduled | SPECT
Item
2. all subjects must be scheduled for or have undergone spect within 28 days prior to or following study day 1
boolean
C0040399 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0040399 (UMLS CUI [2])
Coronary Artery Disease Probability Very low | Coronary Artery Disease Probability low | Participation Clinical Trial Specified
Item
3. subjects with very low/low pre-test probability of coronary artery disease must consent to participate in the extension trial 127-014-a
boolean
C1956346 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
C0442811 (UMLS CUI [1,3])
C1956346 (UMLS CUI [2,1])
C0033204 (UMLS CUI [2,2])
C0205251 (UMLS CUI [2,3])
C0679823 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
Coronary Artery Disease Probability Very low | Coronary Artery Disease Probability low | Coronary Artery Disease Obstructive Absent Angiography | Myocardial Infarction Absent
Item
4. subjects with very low/low pre-test probability of coronary artery disease must not have a current diagnosis of obstructive cad on angiogram or prior mi
boolean
C1956346 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
C0442811 (UMLS CUI [1,3])
C1956346 (UMLS CUI [2,1])
C0033204 (UMLS CUI [2,2])
C0205251 (UMLS CUI [2,3])
C1956346 (UMLS CUI [3,1])
C0549186 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0002978 (UMLS CUI [3,4])
C0027051 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Coronary Artery Disease Probability Very low | Coronary Artery Disease Probability low | Coronary Artery Disease Obstructive Angiography | Myocardial Infarction
Item
5. subjects with very low/low pre-test probability of coronary artery disease with a current diagnosis of obstructive cad on angiogram or prior mi may be enrolled into stratum 2
boolean
C1956346 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
C0442811 (UMLS CUI [1,3])
C1956346 (UMLS CUI [2,1])
C0033204 (UMLS CUI [2,2])
C0205251 (UMLS CUI [2,3])
C1956346 (UMLS CUI [3,1])
C0549186 (UMLS CUI [3,2])
C0002978 (UMLS CUI [3,3])
C0027051 (UMLS CUI [4])
Coronary Artery Disease Probability Intermediate | Coronary Artery Disease Probability High | Coronary angiography Scheduled
Item
6. subjects with intermediate or high pre-test probability of coronary artery disease must be scheduled for coronary angiography within the 28 days following study day 1
boolean
C1956346 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
C0205103 (UMLS CUI [1,3])
C1956346 (UMLS CUI [2,1])
C0033204 (UMLS CUI [2,2])
C0205250 (UMLS CUI [2,3])
C0085532 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
Sinus rhythm
Item
7. sinus rhythm at the time of the study procedure
boolean
C0232201 (UMLS CUI [1])
Visualization Segment Myocardial
Item
8. adequate visualization of myocardial segments
boolean
C0178707 (UMLS CUI [1,1])
C0441635 (UMLS CUI [1,2])
C1522564 (UMLS CUI [1,3])
Patient Appropriate Exercise stress test
Item
9. appropriate candidate for stress testing according to acc/aha guidelines for exercise testing
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0015260 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
1. women who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity | Medical contraindication
Item
2. 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 | Proteins
Item
3. blood, blood products, albumin, egg, or protein
boolean
C0005767 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
C0001924 (UMLS CUI [3])
C0013710 (UMLS CUI [4])
C0033684 (UMLS CUI [5])
Caffeine products | Product Containing Xanthine
Item
3. use of caffeine or xanthine containing products within the 24 hours prior to 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 Contrast Agent for Ultrasound Imaging
Item
4. previous exposure to pb127 ultrasound contrast agent
boolean
C0332157 (UMLS CUI [1,1])
C1959382 (UMLS CUI [1,2])
C2917331 (UMLS CUI [1,3])
Major surgery Requirement General Anesthesia | Major surgery Requirement Overnight dwell
Item
5. major surgery within 7 days prior to study day 1 (requiring general anesthesia and/or overnight stay)
boolean
C0679637 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0002915 (UMLS CUI [1,3])
C0679637 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C4072787 (UMLS CUI [2,3])
Heart Transplantation | Coronary Artery Bypass Surgery
Item
6. heart transplant or history of cabg
boolean
C0018823 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
Right to left cardiovascular shunt Significant Hemodynamic | Right to left cardiovascular shunt Symptomatic | Cardiac shunt Associated with Transient Ischemic Attack | Cardiac shunt Associated with Cerebrovascular accident
Item
7. known hemodynamically significant or symptomatic right-to-left shunt (including shunts that are associated with prior tias or strokes)
boolean
C0428871 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0019010 (UMLS CUI [1,3])
C0428871 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0232180 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0007787 (UMLS CUI [3,3])
C0232180 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0038454 (UMLS CUI [4,3])
Sustained ventricular tachycardia
Item
8. recent history of sustained ventricular tachycardia
boolean
C0750197 (UMLS CUI [1])
Artificial cardiac pacemaker | Defibrillators
Item
9. pacemaker or defibrillator
boolean
C0030163 (UMLS CUI [1])
C0180307 (UMLS CUI [2])
Cardiac Status Unstable
Item
10. unstable cardiac status
boolean
C1999091 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Unstable Angina Canadian Cardiovascular Society classification of angina | Physical activity causes Symptoms Limiting | Symptoms At rest Exercise-induced angina | Symptoms Continuous | Nitroglycerin Intravenous infusion
Item
1. unstable angina grade ccs class iv severity (any physical activity causes limiting symptoms; symptoms may be present at rest in a patient with prior exertional angina) with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin
boolean
C0002965 (UMLS CUI [1,1])
C1277207 (UMLS CUI [1,2])
C0026606 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
C1457887 (UMLS CUI [3,1])
C0443144 (UMLS CUI [3,2])
C0577698 (UMLS CUI [3,3])
C1457887 (UMLS CUI [4,1])
C0549178 (UMLS CUI [4,2])
C0017887 (UMLS CUI [5,1])
C0021440 (UMLS CUI [5,2])
Decompensated cardiac failure
Item
2. decompensated heart failure
boolean
C0581377 (UMLS CUI [1])
Second degree atrioventricular block | Complete atrioventricular block | Sick Sinus Syndrome
Item
3. second-degree or greater heart block, sick sinus syndrome
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0037052 (UMLS CUI [3])
Ventricular ectopics Frequently | Ventricular ectopics Symptomatic
Item
4. frequent (>60/hour) or symptomatic ventricular ectopics at baseline
boolean
C0428994 (UMLS CUI [1,1])
C0332183 (UMLS CUI [1,2])
C0428994 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Hypertensive disease | Systolic Pressure | Diastolic blood pressure | Blood pressure determination Consecutive Quantity | PB-127 compound
Item
5. hypertension (sbp >200 and/or dbp >110 mmhg on two consecutive readings within one hour of pb127 mpe)
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])
C1959382 (UMLS CUI [5])
Hypotension | Systolic Pressure
Item
6. hypotension (sbp <90 mmhg)
boolean
C0020649 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Aortic stenosis, severe | Gradient mean | Aortic valve area Index
Item
7. severe aortic stenosis (>40 mmhg mean gradient or <0.6 cm2/m2 valve area index)
boolean
C3806272 (UMLS CUI [1])
C0812409 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0428817 (UMLS CUI [3,1])
C0918012 (UMLS CUI [3,2])
Pulmonary Edema
Item
8. pulmonary edema within the 7 days prior to study day 1
boolean
C0034063 (UMLS CUI [1])
Oxygen saturation At rest Percentage on room air
Item
9. resting oxygen saturation of less than 90% on room air
boolean
C0523807 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C2709070 (UMLS CUI [1,4])
Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack
Item
11. myocardial infarction or cerebral vascular accident / transient ischemic attack within the 28 days prior to study day 1
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Chronic Obstructive Airway Disease | Bronchial Spasm | Medical contraindication Dipyridamole
Item
12. chronic obstructive pulmonary disease (copd) 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
13. 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
14. liver disease characterized by one or more of the following
boolean
C0023895 (UMLS CUI [1])
Icterus
Item
1. current jaundice
boolean
C0022346 (UMLS CUI [1])
Increased bilirubin level
Item
2. elevated bilirubin > upper limit of normal
boolean
C0311468 (UMLS CUI [1])
Elevated liver enzymes
Item
3. currently elevated hepatic enzymes > 2x upper limit of normal
boolean
C0235996 (UMLS CUI [1])
Viral hepatitis | Hepatitis A Excluded
Item
4. current or previous hepatic viral infection (not including hepatitis a)
boolean
C0042721 (UMLS CUI [1])
C0019159 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Hepatitis, Chronic
Item
5. chronic hepatitis
boolean
C0019189 (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
15. 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])