ID

23942

Beschreibung

Feasibility and Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Elective PCI; ODM derived from: https://clinicaltrials.gov/show/NCT00715455

Link

https://clinicaltrials.gov/show/NCT00715455

Stichworte

Versionen (1)
  1. 19.07.17 19.07.17 -
Hochgeladen am

19. Juli 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00715455

Englisch

Eligibility Coronary Artery Disease NCT00715455

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females scheduled for non-urgent elective pci (who do not have certain cardiac parameters) and have not been treated with uhf prior to pci.
Beschreibung

Gender | Percutaneous Coronary Intervention elective Scheduled | Parameters cardiac Absent | Unfractionated heparin therapy Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1532338
UMLS CUI [2,2]
C0439608
UMLS CUI [2,3]
C0205539
UMLS CUI [3,1]
C0449381
UMLS CUI [3,2]
C0018787
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C4076594
UMLS CUI [4,2]
C0332197
subject able to give informed consent and comply with the protocol.
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
negative urine pregnancy test or documented surgical sterilization or menopausal.
Beschreibung

Urine pregnancy test negative | Female Sterilization | Menopausal

Datentyp

boolean

Alias
UMLS CUI [1]
C0430057
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0025320
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject weight >120 kg.
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
recent acute coronary syndrome with elevated cardiac markers or st segment depression at rest.
Beschreibung

Acute Coronary Syndrome | Cardiac markers Elevated | ST segment depression At rest

Datentyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2,1]
C1271630
UMLS CUI [2,2]
C3163633
UMLS CUI [3,1]
C0520887
UMLS CUI [3,2]
C0443144
evidence of clinical instability
Beschreibung

Instability Clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1444783
UMLS CUI [1,2]
C0205210
angiographic high-risk.
Beschreibung

Angiography High risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002978
UMLS CUI [1,2]
C0332167
a contraindication to anticoagulation or increased risk of bleeding.
Beschreibung

Medical contraindication Anticoagulation Therapy | High risk of bleeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003281
UMLS CUI [2]
C4039184
use of prohibited medications or investigational drugs prior to the study.
Beschreibung

Illicit drug use | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0281875
UMLS CUI [2]
C0013230
clinically significant abnormal laboratory findings.
Beschreibung

Laboratory test result abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0438215
planned use of femoral sheath greater than a certain size.
Beschreibung

Band Tissue Femoral Size | Use Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0175723
UMLS CUI [1,2]
C0040300
UMLS CUI [1,3]
C0015811
UMLS CUI [1,4]
C0456389
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C1301732
known allergy or intolerance to drugs mandated by the study.
Beschreibung

Hypersensitivity Investigational New Drugs | Intolerance to Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0013230
use of devices other than angioplasty balloons and coronary stents.
Beschreibung

Medical Devices Use of | Angioplasty Balloon Excluded | Coronary stent Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025080
UMLS CUI [1,2]
C1524063
UMLS CUI [2,1]
C0002996
UMLS CUI [2,2]
C2828389
UMLS CUI [3,1]
C0687568
UMLS CUI [3,2]
C2828389
a history of licit drug abuse or illicit drug use or current evidence of such abuse.
Beschreibung

Drug abuse | Illicit drug use

Datentyp

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0281875
any other factor that the investigator feels would put the subject at increased risk if participating in the protocol.
Beschreibung

Factor Study Subject Participation Status At risk Increased

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C0205217
lactation.
Beschreibung

Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
currently enrolled in this or another clinical trial (with some exceptions).
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
participation in an investigational drug or device trial in the past 30 days.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT00715455

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Percutaneous Coronary Intervention elective Scheduled | Parameters cardiac Absent | Unfractionated heparin therapy Absent
Item
males or females scheduled for non-urgent elective pci (who do not have certain cardiac parameters) and have not been treated with uhf prior to pci.
boolean
C0079399 (UMLS CUI [1])
C1532338 (UMLS CUI [2,1])
C0439608 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C0449381 (UMLS CUI [3,1])
C0018787 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C4076594 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Informed Consent | Protocol Compliance
Item
subject able to give informed consent and comply with the protocol.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Urine pregnancy test negative | Female Sterilization | Menopausal
Item
negative urine pregnancy test or documented surgical sterilization or menopausal.
boolean
C0430057 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0025320 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Body Weight
Item
subject weight >120 kg.
boolean
C0005910 (UMLS CUI [1])
Acute Coronary Syndrome | Cardiac markers Elevated | ST segment depression At rest
Item
recent acute coronary syndrome with elevated cardiac markers or st segment depression at rest.
boolean
C0948089 (UMLS CUI [1])
C1271630 (UMLS CUI [2,1])
C3163633 (UMLS CUI [2,2])
C0520887 (UMLS CUI [3,1])
C0443144 (UMLS CUI [3,2])
Instability Clinical
Item
evidence of clinical instability
boolean
C1444783 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
Angiography High risk
Item
angiographic high-risk.
boolean
C0002978 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
Medical contraindication Anticoagulation Therapy | High risk of bleeding
Item
a contraindication to anticoagulation or increased risk of bleeding.
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C4039184 (UMLS CUI [2])
Illicit drug use | Investigational New Drugs
Item
use of prohibited medications or investigational drugs prior to the study.
boolean
C0281875 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Laboratory test result abnormal
Item
clinically significant abnormal laboratory findings.
boolean
C0438215 (UMLS CUI [1])
Band Tissue Femoral Size | Use Planned
Item
planned use of femoral sheath greater than a certain size.
boolean
C0175723 (UMLS CUI [1,1])
C0040300 (UMLS CUI [1,2])
C0015811 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,4])
C1524063 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs | Intolerance to Investigational New Drugs
Item
known allergy or intolerance to drugs mandated by the study.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Medical Devices Use of | Angioplasty Balloon Excluded | Coronary stent Excluded
Item
use of devices other than angioplasty balloons and coronary stents.
boolean
C0025080 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0002996 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0687568 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
Drug abuse | Illicit drug use
Item
a history of licit drug abuse or illicit drug use or current evidence of such abuse.
boolean
C0013146 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
Factor Study Subject Participation Status At risk Increased
Item
any other factor that the investigator feels would put the subject at increased risk if participating in the protocol.
boolean
C1521761 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0205217 (UMLS CUI [1,4])
Breast Feeding
Item
lactation.
boolean
C0006147 (UMLS CUI [1])
Study Subject Participation Status
Item
currently enrolled in this or another clinical trial (with some exceptions).
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
participation in an investigational drug or device trial in the past 30 days.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
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