ID

16877

Beschreibung

Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II); ODM derived from: https://clinicaltrials.gov/show/NCT00088179

Link

https://clinicaltrials.gov/show/NCT00088179

Stichworte

Versionen (2)
  1. 11.08.16 11.08.16 -
  2. 11.08.16 11.08.16 -
Hochgeladen am

11. August 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00088179

Englisch

Eligibility Coronary Artery Disease NCT00088179

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
be at least 18 years of age;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
have 2 or more of the following risk factors:
Beschreibung

risk factors Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1265611
• diabetes mellitus; • repeat cabg; • the need for urgent intervention, defined according to the acc/aha guidelines as being patients who are required to stay in the hospital due to medical factors, but may be scheduled and operated on within a normal scheduling routine, excluding patients who have had an mi within 48 hours of cabg; •
Beschreibung

Diabetes Mellitus | Coronary Artery Bypass Surgery Repeat | Surgical and medical procedure Urgent | Hospitalization Due to medical condition | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2,1]
C0010055
UMLS CUI [2,2]
C0205341
UMLS CUI [3,1]
C1948041
UMLS CUI [3,2]
C0439609
UMLS CUI [4,1]
C0019993
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C3843040
UMLS CUI [5]
C0027051
female; • history of a neurologic event (cerebrovascular accident, transient ischemic attack or carotid endarterectomy); • history of congestive heart failure (nyha chf class iii or iv); • history of 2 mis, or an mi that occurred greater than 48 hours but less than 4 weeks prior to cabg;
Beschreibung

Gender | Neurological event | Cerebrovascular accident | Transient Ischemic Attack | Carotid Endarterectomy | Congestive heart failure | New York Heart Association Classification | Myocardial Infarction Quantity | Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C1320718
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0007787
UMLS CUI [5]
C0014099
UMLS CUI [6]
C0018802
UMLS CUI [7]
C1275491
UMLS CUI [8,1]
C0027051
UMLS CUI [8,2]
C1265611
UMLS CUI [9]
C0010055
provide informed consent.
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
requires salvage intervention as defined by the acc/aha guidelines 10 as being ongoing cardiopulmonary resuscitation on the way to the operating room;
Beschreibung

Salvage procedure Patient need for | Cardiopulmonary Resuscitation Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442967
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C0007203
UMLS CUI [2,2]
C0549178
has current cardiogenic shock, acute left ventricular rupture, acute septal rupture or acute papillary muscle rupture;
Beschreibung

Shock, Cardiogenic | Myocardial rupture left ventricle | Acute ventricular septal rupture | Rupture of papillary muscle

Datentyp

boolean

Alias
UMLS CUI [1]
C0036980
UMLS CUI [2,1]
C0018813
UMLS CUI [2,2]
C1269892
UMLS CUI [3]
C1299445
UMLS CUI [4]
C0155713
has any active bacterial or other infection which is clinically significant, in the opinion of the investigator (e.g. evaluate the evidence based on wbc, temperature, cultures etc. as appropriate for the patient);
Beschreibung

Bacterial Infection Clinical Significance | Communicable Disease Clinical Significance | evaluation of evidence | White Blood Cell Count procedure | Body Temperature | Laboratory culture

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C2826293
UMLS CUI [3]
C1327779
UMLS CUI [4]
C0023508
UMLS CUI [5]
C0005903
UMLS CUI [6]
C0430400
has a known or suspected hereditary complement deficiency;
Beschreibung

hereditary serum complement deficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C2030722
has participated in any other investigational drug study or was exposed to an investigational agent or device within 30 days of randomization;
Beschreibung

Study Subject Participation Status | Investigational New Drugs Exposure to | Investigational Medical Device Exposure to

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0332157
UMLS CUI [3,1]
C2346570
UMLS CUI [3,2]
C0332157
is receiving, or is planning to receive, any other investigational drug or device, or will participate in any other research study within 30 days of randomization;
Beschreibung

Investigational New Drug Receive | Investigational Medical Device Receive | Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1514756
UMLS CUI [2,1]
C2346570
UMLS CUI [2,2]
C1514756
UMLS CUI [3]
C2348568
is pregnant or breast-feeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT00088179

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
be at least 18 years of age;
boolean
C0001779 (UMLS CUI [1])
risk factors Quantity
Item
have 2 or more of the following risk factors:
boolean
C0035648 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Diabetes Mellitus | Coronary Artery Bypass Surgery Repeat | Surgical and medical procedure Urgent | Hospitalization Due to medical condition | Myocardial Infarction
Item
• diabetes mellitus; • repeat cabg; • the need for urgent intervention, defined according to the acc/aha guidelines as being patients who are required to stay in the hospital due to medical factors, but may be scheduled and operated on within a normal scheduling routine, excluding patients who have had an mi within 48 hours of cabg; •
boolean
C0011849 (UMLS CUI [1])
C0010055 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
C1948041 (UMLS CUI [3,1])
C0439609 (UMLS CUI [3,2])
C0019993 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C3843040 (UMLS CUI [4,3])
C0027051 (UMLS CUI [5])
Gender | Neurological event | Cerebrovascular accident | Transient Ischemic Attack | Carotid Endarterectomy | Congestive heart failure | New York Heart Association Classification | Myocardial Infarction Quantity | Coronary Artery Bypass Surgery
Item
female; • history of a neurologic event (cerebrovascular accident, transient ischemic attack or carotid endarterectomy); • history of congestive heart failure (nyha chf class iii or iv); • history of 2 mis, or an mi that occurred greater than 48 hours but less than 4 weeks prior to cabg;
boolean
C0079399 (UMLS CUI [1])
C1320718 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
C0014099 (UMLS CUI [5])
C0018802 (UMLS CUI [6])
C1275491 (UMLS CUI [7])
C0027051 (UMLS CUI [8,1])
C1265611 (UMLS CUI [8,2])
C0010055 (UMLS CUI [9])
Informed consent
Item
provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Salvage procedure Patient need for | Cardiopulmonary Resuscitation Continuous
Item
requires salvage intervention as defined by the acc/aha guidelines 10 as being ongoing cardiopulmonary resuscitation on the way to the operating room;
boolean
C0442967 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0007203 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
Shock, Cardiogenic | Myocardial rupture left ventricle | Acute ventricular septal rupture | Rupture of papillary muscle
Item
has current cardiogenic shock, acute left ventricular rupture, acute septal rupture or acute papillary muscle rupture;
boolean
C0036980 (UMLS CUI [1])
C0018813 (UMLS CUI [2,1])
C1269892 (UMLS CUI [2,2])
C1299445 (UMLS CUI [3])
C0155713 (UMLS CUI [4])
Bacterial Infection Clinical Significance | Communicable Disease Clinical Significance | evaluation of evidence | White Blood Cell Count procedure | Body Temperature | Laboratory culture
Item
has any active bacterial or other infection which is clinically significant, in the opinion of the investigator (e.g. evaluate the evidence based on wbc, temperature, cultures etc. as appropriate for the patient);
boolean
C0004623 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C1327779 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0005903 (UMLS CUI [5])
C0430400 (UMLS CUI [6])
hereditary serum complement deficiency
Item
has a known or suspected hereditary complement deficiency;
boolean
C2030722 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs Exposure to | Investigational Medical Device Exposure to
Item
has participated in any other investigational drug study or was exposed to an investigational agent or device within 30 days of randomization;
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C2346570 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
Investigational New Drug Receive | Investigational Medical Device Receive | Study Subject Participation Status
Item
is receiving, or is planning to receive, any other investigational drug or device, or will participate in any other research study within 30 days of randomization;
boolean
C0013230 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C2346570 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C2348568 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
is pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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