ID

31329

Descrição

Study ID: 104574 Clinical Study ID: AR1104574 Study Title: A randomized blinded pilot trial of fondaparinux sodium (Arixtra®) versus unfractionated heparin in addition to standard therapy in a broad range of patients undergoing percutaneous coronary intervention (ASPIRE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thromboembolism

Palavras-chave

Versões (3)
  1. 13/08/2018 13/08/2018 -
  2. 13/08/2018 13/08/2018 -
  3. 13/08/2018 13/08/2018 - Julian Varghese
Titular dos direitos

GlaxoSmithKline

Transferido a

13 de agosto de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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Fondaparinux sodium (Arixtra) versus unfractionated heparin with patients undergoing PCI; Clinical Study ID: AR1104574

Inglês

MI Report

1 Formulários  
  1. StudyEvent: ODM
    1. MI Report
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient ID, Centre No.
Descrição

Patient ID; Centre Number

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1269815
UMLS CUI [1,2]
C2825181
UMLS CUI [1,3]
C1300638
Patient ID, Envelope No.
Descrição

Patient ID; Envelope Number

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1269815
UMLS CUI [1,2]
C2348585
Patient Initials
Descrição

Patient Initials

Tipo de dados

text

Alias
UMLS CUI [1]
C2986440
Myocardial Infarction
Descrição

Myocardial Infarction

Alias
UMLS CUI-1
C0027051
Onset of Myocardial (re)infarction - Date
Descrição

Myocardial infarction onset date; myocardial reinfarction onset date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0574845
UMLS CUI [2,1]
C0948369
UMLS CUI [2,2]
C0574845
Onset of Myocardial (re)infarction - Time
Descrição

Myocardial infarction onset time; myocardial reinfarction onset time

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0449244
UMLS CUI [2,1]
C0948369
UMLS CUI [2,2]
C0449244
Was patient hospitalized at time of this MI?
Descrição

MI during hospitalization

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2825213
New Admission Date
Descrição

MI; new admissions date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0184666
UMLS CUI [1,3]
C0011008
Discharge date
Descrição

Myocardial Infarction Discharge date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C2710998
Indicate criteria met for diagnosis of acute myocardial (re) infarction
Descrição

MI; diagnosis criteria

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0243161
Was ECG done
Descrição

ECG

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1623258
ECG date
Descrição

ECG date

Tipo de dados

date

Alias
UMLS CUI [1]
C2826640
ECG time
Descrição

ECG time

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
ECG time
Descrição

ECG result

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
Cardiac enzymes and markers
Descrição

Cardiac enzymes and markers

Alias
UMLS CUI-1
C0443763
UMLS CUI-2
C1271630
Elevation of Cardiac Enzymes consistent with myocardial infarction
Descrição

MI; elevation cardiac enzymes

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0443763
UMLS CUI [1,3]
C0702240
Cardiac enzyme or marker measured
Descrição

Cardiac enzyme measured

Tipo de dados

text

Alias
UMLS CUI [1]
C0201934
Date
Descrição

Cardiac enzyme measured, date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0201934
UMLS CUI [1,2]
C0011008
Time
Descrição

Cardiac enzyme measured, time

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0201934
UMLS CUI [1,2]
C0040223
Value
Descrição

Cardiac enzyme measured, value

Tipo de dados

float

Alias
UMLS CUI [1,1]
C0201934
UMLS CUI [1,2]
C0587081
Cardiac enzyme or marker measured
Descrição

Cardiac enzyme measured

Tipo de dados

text

Alias
UMLS CUI [1]
C0201934
Date
Descrição

Cardiac enzyme measured, date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0201934
UMLS CUI [1,2]
C0011008
Time
Descrição

Cardiac enzyme measured, time

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0201934
UMLS CUI [1,2]
C0040223
Value
Descrição

Cardiac enzyme measured, value

Tipo de dados

float

Alias
UMLS CUI [1,1]
C0201934
UMLS CUI [1,2]
C0587081
Myocardial Infarction Consequences
Descrição

Myocardial Infarction Consequences

Alias
UMLS CUI-1
C0027051
UMLS CUI-2
C1547646
Did patient receive thrombolytic therapy for this event?
Descrição

Myocardial Infarction; Thrombolytic Therapy

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0040044
Did this MI lead to repeat PCI or CABG procedure?
Descrição

Myocardial Infarction, Percutaneous Coronary Intervention, Repeat; Myocardial Infarction, Coronary Artery Bypass Surgery, Repeat

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C1532338
UMLS CUI [1,3]
C0205341
UMLS CUI [2,1]
C0027051
UMLS CUI [2,2]
C0010055
UMLS CUI [2,3]
C0205341
Has patient died?
Descrição

MI; Death

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0011065
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Similar models

MI Report

1 Formulários
  1. StudyEvent: ODM
    1. MI Report
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient ID; Centre Number
Item
Patient ID, Centre No.
text
C1269815 (UMLS CUI [1,1])
C2825181 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,3])
Patient ID; Envelope Number
Item
Patient ID, Envelope No.
text
C1269815 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Myocardial Infarction
C0027051 (UMLS CUI-1)
Myocardial infarction onset date; myocardial reinfarction onset date
Item
Onset of Myocardial (re)infarction - Date
date
C0027051 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0948369 (UMLS CUI [2,1])
C0574845 (UMLS CUI [2,2])
Myocardial infarction onset time; myocardial reinfarction onset time
Item
Onset of Myocardial (re)infarction - Time
time
C0027051 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C0948369 (UMLS CUI [2,1])
C0449244 (UMLS CUI [2,2])
MI during hospitalization
Item
Was patient hospitalized at time of this MI?
boolean
C2825213 (UMLS CUI [1])
MI; new admissions date
Item
New Admission Date
date
C0027051 (UMLS CUI [1,1])
C0184666 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Myocardial Infarction Discharge date
Item
Discharge date
date
C0027051 (UMLS CUI [1,1])
C2710998 (UMLS CUI [1,2])
Item
Indicate criteria met for diagnosis of acute myocardial (re) infarction
text
C0027051 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
MI; diagnosis criteria
Code List
Indicate criteria met for diagnosis of acute myocardial (re) infarction
CL Item
New significant or pathological Q-waves (New significant or pathological Q-waves)
CL Item
ECG changes indicative of ischemia (ST-segment elevation or depression) (ECG changes indicative of ischemia (ST-segment elevation or depression))
CL Item
New LBBB (New LBBB)
CL Item
CK or CK-MB 3 x ULN or 50% or more over previous valley level (most recent nadir enzyme level) (CK or CK-MB 3 x ULN or 50% or more over previous valley level (most recent nadir enzyme level))
CL Item
Troponin I or T > 3 x ULN post PCI (if pre-PCI troponin normal) (Troponin I or T > 3 x ULN post PCI (if pre-PCI troponin normal))
CL Item
Coronary artery intervention (Coronary artery intervention)
CL Item
Pathological finding (Pathological finding)
CL Item
Ischemic symptoms (give onset date and time) (Ischemic symptoms (give onset date and time))
CL Item
Typical rise & fall of biochemical markers of necrosis to > 2x ULN (Typical rise & fall of biochemical markers of necrosis to > 2x ULN)
ECG
Item
Was ECG done
boolean
C1623258 (UMLS CUI [1])
ECG date
Item
ECG date
date
C2826640 (UMLS CUI [1])
ECG time
Item
ECG time
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
ECG time
text
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
ECG result
Code List
ECG time
CL Item
Normal (Normal)
CL Item
Abnormal (give Type and Location) (Abnormal (give Type and Location))
Item Group
Cardiac enzymes and markers
C0443763 (UMLS CUI-1)
C1271630 (UMLS CUI-2)
MI; elevation cardiac enzymes
Item
Elevation of Cardiac Enzymes consistent with myocardial infarction
boolean
C0027051 (UMLS CUI [1,1])
C0443763 (UMLS CUI [1,2])
C0702240 (UMLS CUI [1,3])
Item
Cardiac enzyme or marker measured
text
C0201934 (UMLS CUI [1])
Cardiac enzyme measured
Code List
Cardiac enzyme or marker measured
CL Item
CK (U/L) (CK (U/L))
(Comment:en)
CL Item
CK-MB (U/L) (CK-MB (U/L))
(Comment:en)
CL Item
CK-MB (%) (CK-MB (%))
(Comment:en)
CL Item
CK-MB Mass (ug/L) (CK-MB Mass (ug/L))
CL Item
Troponin T (ug/L) (Troponin T (ug/L))
CL Item
Troponin I (ug/L) (Troponin I (ug/L))
Cardiac enzyme measured, date
Item
Date
date
C0201934 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Cardiac enzyme measured, time
Item
Time
time
C0201934 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Cardiac enzyme measured, value
Item
Value
float
C0201934 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Cardiac enzyme or marker measured
text
C0201934 (UMLS CUI [1])
Cardiac enzyme measured
Code List
Cardiac enzyme or marker measured
CL Item
CK (U/L) (CK (U/L))
CL Item
CK-MB (U/L) (CK-MB (U/L))
CL Item
CK-MB (%) (CK-MB (%))
CL Item
CK-MB Mass (ug/L) (CK-MB Mass (ug/L))
CL Item
Troponin T (ug/L) (Troponin T (ug/L))
CL Item
Troponin I (ug/L) (Troponin I (ug/L))
Cardiac enzyme measured, date
Item
Date
date
C0201934 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Cardiac enzyme measured, time
Item
Time
time
C0201934 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Cardiac enzyme measured, value
Item
Value
float
C0201934 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item Group
Myocardial Infarction Consequences
C0027051 (UMLS CUI-1)
C1547646 (UMLS CUI-2)
Item
Did patient receive thrombolytic therapy for this event?
text
C0027051 (UMLS CUI [1,1])
C0040044 (UMLS CUI [1,2])
undefined item
Code List
Did patient receive thrombolytic therapy for this event?
CL Item
No (No)
CL Item
Yes - tPA (Yes - tPA)
CL Item
Yes - SK (Yes - SK)
CL Item
Yes - rPA (Yes - rPA)
CL Item
Yes - Other (Yes - Other)
Myocardial Infarction, Percutaneous Coronary Intervention, Repeat; Myocardial Infarction, Coronary Artery Bypass Surgery, Repeat
Item
Did this MI lead to repeat PCI or CABG procedure?
boolean
C0027051 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0027051 (UMLS CUI [2,1])
C0010055 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
MI; Death
Item
Has patient died?
boolean
C0027051 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
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