ID

31819

Descrizione

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

Keywords

Clinical Trial

Percutaneous Coronary Intervention

D002309

D016033

D013923

Titolare del copyright

GlaxoSmithKline

Caricato su

1 ottobre 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0

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Fondaparinux sodium (Arixtra) versus unfractionated heparin with patients undergoing PCI; Study ID: 104574

model
Dettagli

Re-Intervention Report

1 moduli

StudyEvent: ODM
1. Re-Intervention Report

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Administrative Data

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])

Interventional Procedure; Report

Item Group

Intervention Report

C0184661 (UMLS CUI-1)
C0684224 (UMLS CUI-2)

Interventional Procedure; primary reason

Item

Indicate primary reason for intervention

text

C0184661 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])

Adverse Event; Onset of; Date and Time

Item

Onset date and time of clinical symptoms leading to intervention

datetime

C0332162 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1717740 (UMLS CUI [1,3])

Interventional procedure; Hospitalization; Status

Item

Patient hospitalized at the time of re-intervention?

text

C0184661 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])

undefined item

Code List

Patient hospitalized at the time of re-intervention?

CL Item

No (Give date and time of re-admission) (No (Give date and time of re-admission))

CL Item

Yes (Yes)

CL Item

Occured during initial hospital phase (Occured during initial hospital phase)

Electrocardiography

Item

Was ECG done?

boolean

C1623258 (UMLS CUI [1])

Electrocardiography; Date in time; Time

Item

Was ECG done? - Date and time

datetime

C1623258 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])

Electrocardiography; Date in time; Time

Item

Was ECG done? - Date and time

datetime

C1623258 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])

Electrocardiography; Result

Item

Was ECG done? - result

text

C1623258C1274040 (UMLS CUI [1])

Electrocardiography; Result

Code List

Was ECG done? - result

CL Item

Normal (Normal)

CL Item

Abnormal (give type and location) (Abnormal (give type and location))

Interventional procedure; Hemorrhage; Associated with

Item

Was bleeding associated with the intervention?

boolean

C0184661 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])

Coronary Angiography

Item Group

Coronary Angiography

C0085532 (UMLS CUI-1)

coronary angiography

Item

Was coronary angiography done?

boolean

C0085532 (UMLS CUI [1])

coronary angiography; start date; start time

Item

Coronary angiography - start date and time

datetime

C0085532 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])

coronary angiography; result

Item

Coronary angiography - significant disease?

boolean

C0085532 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])

coronary angiography; left main coronary artery stenosis

Item

Coronary angiography - stenosis Left Main

integer

C0085532 (UMLS CUI [1,1])
C2062905 (UMLS CUI [1,2])

coronary angiography; Proximal Left Anterior Descending Coronary Artery Stenosis

Item

Coronary angiography - stenosis proximal LAD

integer

C0085532 (UMLS CUI [1,1])
C2825180 (UMLS CUI [1,2])

coronary angiography; Left anterior descending coronary artery stenosis; Distal

Item

Coronary angiography - stenosis mid/distal LAD

integer

C0085532 (UMLS CUI [1,1])
C3267165 (UMLS CUI [1,2])
C0205108 (UMLS CUI [1,3])

coronary angiography; CORONARY STENOSIS CIRCUMFLEX

Item

Coronary angiography - stenosis Circumflex

integer

C0085532 (UMLS CUI [1,1])
C0742837 (UMLS CUI [1,2])

coronary angiography; Right coronary artery stenosis

Item

Coronary angiography - stenosis RCA

integer

C0085532 (UMLS CUI [1,1])
C3267166 (UMLS CUI [1,2])

coronary angiography; Saphenous vein graft; Stenosis

Item

Coronary angiography - stenosis SVG

integer

C0085532 (UMLS CUI [1,1])
C0729538 (UMLS CUI [1,2])
C1261287 (UMLS CUI [1,3])

coronary angiography; Arterial graft; Stenosis

Item

Coronary angiography - stenosis Arterial graft

integer

C0085532 (UMLS CUI [1,1])
C0450140 (UMLS CUI [1,2])
C1261287 (UMLS CUI [1,3])

Left Ventricular Function; Assessed

Item

Was ventricular function assessed

boolean

C0080310 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])

Left Ventricular Function; Left ventricular ejection fraction

Item

ventricular function - LVEF

integer

C0080310 (UMLS CUI [1,1])
C0428772 (UMLS CUI [1,2])

Left Ventricular Function; Result

Item

ventricular function - result

integer

C0080310 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])

Left Ventricular Function; Result

Code List

ventricular function - result

CL Item

No impairment (1)

CL Item

Mild impairment (2)

CL Item

Moderate impairment (3)

CL Item

Severe impairment (4)

Coronary angiography; Coronary Artery Bypass Surgery; Percutaneous Coronary Intervention

Item

Did this coronary angiography lead to repeat PCI or CABG?

boolean

C0085532 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])

Repeat Surgery; Percutaneous Coronary Intervention

Item Group

Repeat PCI

C0035110 (UMLS CUI-1)
C1532338 (UMLS CUI-2)

Repeat Surgery; Percutaneous Coronary Intervention; Date in time; Start time

Item

Date and Start Time

datetime

C0035110 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])

Repeat Surgery; Percutaneous Coronary Intervention; Site of access

Item

Access site

text

C0035110 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0589360 (UMLS CUI [1,3])

Repeat Surgery; Percutaneous Coronary Intervention; Date in time; Start time

Code List

Access site

CL Item

Radial (Radial)

CL Item

Femoral (Femoral)

Repeat Surgery; Percutaneous Coronary Intervention; Procedure urgency

Item

Was this repeat PCI urgent?

boolean

C0035110 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C4049774 (UMLS CUI [1,3])

Repeat Surgery; Percutaneous Coronary Intervention; Pretreatment; thienopyridine

Item

Was a thienopyridine given prior to PCI?

text

C0035110 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C3539076 (UMLS CUI [1,3])
C1120149 (UMLS CUI [1,4])

Repeat Surgery; Percutaneous Coronary Intervention; Pretreatment; thienopyridine

Code List

Was a thienopyridine given prior to PCI?

CL Item

No (No)

CL Item

Yes, Clopidogrel (give date and time started) (Yes, Clopidogrel (give date and time started))

CL Item

Yes, Ticlopidine (give date and time started) (Yes, Ticlopidine (give date and time started))

Glycoprotein IIb/IIIa Antagonist; During; Percutaneous Coronary Intervention

Item

Was a GPIIb/IIIa inhibitor given during PCI?

text

C3640054 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])

Glycoprotein IIb/IIIa Antagonist; During; Percutaneous Coronary Intervention

Code List

Was a GPIIb/IIIa inhibitor given during PCI?

CL Item

No (No)

CL Item

Yes, Upfront (specify: Tirofiban? Eptifibatide? Abciximab?) (Yes, Upfront (specify: Tirofiban? Eptifibatide? Abciximab?))

CL Item

Yes, Bailout (specify: Tirofiban? Eptifibatide? Abciximab?) (Yes, Bailout (specify: Tirofiban? Eptifibatide? Abciximab?))

Glycoprotein IIb/IIIa Antagonist; During; Percutaneous Coronary Intervention

Item

GPIIb/IIIa inhibitor given during PCI - Start Date and Time

datetime

C3640054 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
C1301880 (UMLS CUI [1,5])

Culprit lesion of coronary artery Characteristics; Percutaneous Coronary Intervention Result; Lesion Location

Item

Culprit lesion characteristics & index PCI results - Lesion location

text

C1299364 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,5])
C0450429 (UMLS CUI [1,6])

Culprit lesion of coronary artery Characteristics; Percutaneous Coronary Intervention Result; Maximum Stenosis; Percutaneous Coronary Intervention Before

Item

Culprit lesion characteristics & index PCI results - Maximum stenosis pre-PCI

integer

C1299364 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C0806909 (UMLS CUI [1,5])
C1261287 (UMLS CUI [1,6])
C1532338 (UMLS CUI [1,7])
C0332152 (UMLS CUI [1,8])

Culprit lesion of coronary artery Characteristics; Percutaneous Coronary Intervention Result; Angiocardiography Thrombus

Item

Culprit lesion characteristics & index PCI results - Angiographic Thrombus

boolean

C1299364 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C0002971 (UMLS CUI [1,5])
C0087086 (UMLS CUI [1,6])

Culprit lesion of coronary artery Characteristics; Percutaneous Coronary Intervention Result; American College of Cardiology/American Heart Association Lesion Complexity Class

Item

Culprit lesion characteristics & index PCI results - ACC/AHA Lesion type

text

C1299364 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C3272276 (UMLS CUI [1,5])

Culprit lesion of coronary artery Characteristics; Percutaneous Coronary Intervention Result; Thrombolysis in Myocardial Infarction Flow Before Percutaneous Coronary Intervention

Item

Culprit lesion characteristics & index PCI results - TIMI flow pre-PCI

integer

C1299364 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C3272266 (UMLS CUI [1,5])
C0332152 (UMLS CUI [1,6])
C1532338 (UMLS CUI [1,7])

Culprit lesion of coronary artery Characteristics; Percutaneous Coronary Intervention Result; Minimum Thrombolysis in Myocardial Infarction Flow During Percutaneous Coronary Intervention

Item

Culprit lesion characteristics & index PCI results - Min TIMI flow during PCI

integer

C1299364 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C1524031 (UMLS CUI [1,5])
C3272266 (UMLS CUI [1,6])
C0347984 (UMLS CUI [1,7])
C1532338 (UMLS CUI [1,8])

Culprit lesion of coronary artery Characteristics; Percutaneous Coronary Intervention Result; Maximum Thrombolysis in Myocardial Infarction Flow During Percutaneous Coronary Intervention

Item

Culprit lesion characteristics & index PCI results - Max TIMI flow during PCI

integer

C1299364 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C0806909 (UMLS CUI [1,5])
C3272266 (UMLS CUI [1,6])
C0347984 (UMLS CUI [1,7])
C1532338 (UMLS CUI [1,8])

Culprit lesion of coronary artery Characteristics; Percutaneous Coronary Intervention Result; Thrombolysis in Myocardial Infarction Flow post Percutaneous Coronary Intervention

Item

Culprit lesion characteristics & index PCI results - TIMI flow post PCI

integer

C1299364 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C3272266 (UMLS CUI [1,5])
C0231290 (UMLS CUI [1,6])
C1532338 (UMLS CUI [1,7])

Culprit lesion of coronary artery Characteristics; Percutaneous Coronary Intervention Result; Procedure successful

Item

Culprit lesion characteristics & index PCI results - Procedure Success

boolean

C1299364 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C3258067 (UMLS CUI [1,5])

Culprit lesion of coronary artery Characteristics; Percutaneous Coronary Intervention Result; Interventional procedure

Item

Culprit lesion characteristics & index PCI results - Intervention Type

text

C1299364 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C0184661 (UMLS CUI [1,5])

Culprit lesion of coronary artery Characteristics; Percutaneous Coronary Intervention Result; Stent

Item

Culprit lesion characteristics & index PCI results - Stent

text

C1299364 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C0038257 (UMLS CUI [1,5])

Culprit lesion of coronary artery Characteristics; Percutaneous Coronary Intervention Result; Stent

Code List

Culprit lesion characteristics & index PCI results - Stent

CL Item

Yes, bare stent (Yes, bare stent)

CL Item

Yes, DES (Yes, DES)

CL Item

No (No)

Secure sheath; Extraction; Date in time; Time

Item

Date and time of sheath removal

datetime

C0463345 (UMLS CUI [1,1])
C0185115 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])

Percutaneous Coronary Intervention; Complication; Vascular

Item

Were there any vascular site complications of PCI?

boolean

C1532338 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C1801960 (UMLS CUI [1,3])

Coronary Artery Bypass Surgery

Item Group

CABG Surgery

C0010055 (UMLS CUI-1)

Coronary Artery Bypass Surgery

Item

CABG Surgery - Date and Time

datetime

C0010055 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])

Coronary Artery Bypass Surgery; Procedure urgency

Item

Was this coronary artery bypass graft surgery urgent?

boolean

C0010055 (UMLS CUI [1,1])
C4049774 (UMLS CUI [1,2])

Coronary Artery Bypass Surgery; type

Item

Type of CABG surgery

text

C0010055 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])

Coronary Artery Bypass Surgery; type

Code List

Type of CABG surgery

CL Item

on pump (on pump)

CL Item

off pump (off pump)

CL Item

minimally invasive (minimally invasive)

CL Item

sternotomy (sternotomy)

Coronary Artery Bypass Surgery; Coronary artery bypass, using arterial graft(s); single arterial graft; Numbers

Item

CABG surgery - Number of bypass grafts

integer

C0010055 (UMLS CUI [1,1])
C0371564 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])

Coronary Artery Bypass Surgery; Coronary artery bypass, using arterial graft(s); single arterial graft; Type

Item

CABG surgery - Type of bypass grafts

text

C0010055 (UMLS CUI [1,1])
C0371564 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])

Coronary Artery Bypass Surgery; Coronary artery bypass, using arterial graft(s); single arterial graft; Type

Code List

CABG surgery - Type of bypass grafts

CL Item

LAD - SVG (LAD - SVG)

CL Item

LAD - LIMA/RIMA (LAD - LIMA/RIMA)

CL Item

LAD - Other Arterial (e.g. radial) (LAD - Other Arterial (e.g. radial))

CL Item

LAD - Other (LAD - Other)

CL Item

Diagonal - SVG (Diagonal - SVG)

CL Item

Diagonal - LIMA/RIMA (Diagonal - LIMA/RIMA)

CL Item

Diagonal - Other Arterial (e.g. radial) (Diagonal - Other Arterial (e.g. radial))

CL Item

Diagonal - Other (Diagonal - Other)

CL Item

Circumflex - SVG (Circumflex - SVG)

CL Item

Circumflex - LIMA/RIMA (Circumflex - LIMA/RIMA)

CL Item

Circumflex - Other Arterial (e.g. radial) (Circumflex - Other Arterial (e.g. radial))

CL Item

Circumflex - Other (Circumflex - Other)

CL Item

RCA - SVG (RCA - SVG)

CL Item

RCA - LIMA/RIMA (RCA - LIMA/RIMA)

CL Item

RCA - Other Arterial (e.g. radial) (RCA - Other Arterial (e.g. radial))

CL Item

RCA - Other (RCA - Other)

Antifibrinolytic agents

Item

Anti-fibrinolytic agents

text

C0003304 (UMLS CUI [1])

Antifibrinolytic agents

Code List

Anti-fibrinolytic agents

CL Item

No (No)

CL Item

Yes, Aminocaproic acid (Yes, Aminocaproic acid)

CL Item

Yes, Aprotinin (Yes, Aprotinin)

CL Item

Yes, Cyklokapron (Yes, Cyklokapron)

CL Item

Yes, Other (Yes, Other)

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Commenti del modello :

Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Fondaparinux sodium (Arixtra) versus unfractionated heparin with patients undergoing PCI; Study ID: 104574

Re-Intervention Report

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