ID

35559

Beschrijving

Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02294994

Link

https://clinicaltrials.gov/show/NCT02294994

Trefwoorden

Versies (1)
  1. 09-03-19 09-03-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

9 maart 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02294994

Engels

Eligibility Coronary Artery Disease NCT02294994

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients were recruited from those undergoing pci with a planned placement of an intracoronary stent
Beschrijving

Patient Recruitment | Percutaneous Coronary Intervention | Coronary stent placement Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0242800
UMLS CUI [2]
C1532338
UMLS CUI [3,1]
C0948884
UMLS CUI [3,2]
C1301732
including patients with unstable angina pectoris, acute coronary syndrome or nstemi
Beschrijving

Angina, Unstable | Acute Coronary Syndrome | NSTEMI

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0948089
UMLS CUI [3]
C4255010
experienced ischaemic pain at rest
Beschrijving

Ischemic pain At rest

Datatype

boolean

Alias
UMLS CUI [1,1]
C0745417
UMLS CUI [1,2]
C0443144
lasting 10 minutes and occurring within 7 days before enrollment
Beschrijving

Duration Minute Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0439232
UMLS CUI [1,3]
C1265611
as well as one of the following: ecg changes: new or presumably new st-segment depression greater than or equal to 0.1 mv (1 mm), or transient (< 30 minutes) st-segment elevation greater than or equal to 0.1 mv (1 mm) in at least 2 contiguous leads -abnormal cardiac enzymes within the 24 hours before enrollment, defined as elevated troponin i defined as elevated troponin i (above the normal reference -
Beschrijving

ECG changes | ST segment depression New | ST segment elevation Transitory | Cardiac enzymes Abnormal | Troponin I increased

Datatype

boolean

Alias
UMLS CUI [1]
C0855329
UMLS CUI [2,1]
C0520887
UMLS CUI [2,2]
C0205314
UMLS CUI [3,1]
C0520886
UMLS CUI [3,2]
C0205374
UMLS CUI [4,1]
C0443763
UMLS CUI [4,2]
C0205161
UMLS CUI [5]
C1141949
high-risk angiographic features :lesion/anatomy related bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, syntax score > 26 and chronic total occlusion disease.
Beschrijving

High risk Angiography Feature | Lesion | Bifurcation lesion of coronary artery | Left coronary artery Lesion | Multiple vessel coronary artery disease | Coronary artery Thrombus | Other Coding | Chronic total occlusion of coronary artery

Datatype

boolean

Alias
UMLS CUI [1,1]
C4319571
UMLS CUI [1,2]
C0002978
UMLS CUI [1,3]
C2348519
UMLS CUI [2]
C0221198
UMLS CUI [3]
C1299363
UMLS CUI [4,1]
C1261082
UMLS CUI [4,2]
C0221198
UMLS CUI [5]
C3805196
UMLS CUI [6,1]
C0205042
UMLS CUI [6,2]
C0087086
UMLS CUI [7]
C3846158
UMLS CUI [8]
C1955779
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
increased bleeding risk: ischaemic stroke within the last year or any previous haemorrhagic stroke, tumour or intracranial aneurysm;
Beschrijving

Bleeding risk Increased | Ischemic stroke | Brain hemorrhage | Hemorrhagic tumor | Intracranial Aneurysm Hemorrhagic

Datatype

boolean

Alias
UMLS CUI [1,1]
C3251812
UMLS CUI [1,2]
C0205217
UMLS CUI [2]
C0948008
UMLS CUI [3]
C0553692
UMLS CUI [4]
C1300819
UMLS CUI [5,1]
C0007766
UMLS CUI [5,2]
C0333275
recent (<1 month) trauma or major surgery (including bypass surgery);
Beschrijving

Trauma | Major surgery | Bypass surgery

Datatype

boolean

Alias
UMLS CUI [1]
C3714660
UMLS CUI [2]
C0679637
UMLS CUI [3]
C1536078
active bleeding
Beschrijving

Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1]
C0019080
unexplained clinically significant bleeding, thrombocytopenia (platelet count < 100 x 109/l) or history of thrombocytopenia with gp iib/iiia, heparin or enoxaparin therapy
Beschrijving

Hemorrhage Unexplained | Thrombocytopenia | Platelet Count measurement | Platelet glycoprotein IIb-IIIa | Heparin | Enoxaparin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C4288071
UMLS CUI [2]
C0040034
UMLS CUI [3]
C0032181
UMLS CUI [4]
C1955352
UMLS CUI [5]
C0019134
UMLS CUI [6]
C0206460
angina from secondary causes such as severe uncontrolled hypertension (systolic blood pressure > 180 mm hg despite treatment)
Beschrijving

Angina Pectoris Cause Secondary | Uncontrolled hypertension | Systolic Pressure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0175668
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0871470
valvular disease, congenital heart disease, hypertrophic cardiomyopathy, -
Beschrijving

Valvular disease | Congenital heart disease | Hypertrophic Cardiomyopathy

Datatype

boolean

Alias
UMLS CUI [1]
C3258293
UMLS CUI [2]
C0152021
UMLS CUI [3]
C0007194
thrombolytic therapy within preceding 24 hours
Beschrijving

Thrombolytic Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0040044
receiving antiiib/iiia therapy
Beschrijving

Glycoprotein IIb/IIIa Antagonist

Datatype

boolean

Alias
UMLS CUI [1]
C3640054
creatinine clearance of <30 ml/min
Beschrijving

Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0373595
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Eligibility Coronary Artery Disease NCT02294994

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Patient Recruitment | Percutaneous Coronary Intervention | Coronary stent placement Planned
Item
patients were recruited from those undergoing pci with a planned placement of an intracoronary stent
boolean
C0242800 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
C0948884 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Angina, Unstable | Acute Coronary Syndrome | NSTEMI
Item
including patients with unstable angina pectoris, acute coronary syndrome or nstemi
boolean
C0002965 (UMLS CUI [1])
C0948089 (UMLS CUI [2])
C4255010 (UMLS CUI [3])
Ischemic pain At rest
Item
experienced ischaemic pain at rest
boolean
C0745417 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
Duration Minute Quantity
Item
lasting 10 minutes and occurring within 7 days before enrollment
boolean
C0449238 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
ECG changes | ST segment depression New | ST segment elevation Transitory | Cardiac enzymes Abnormal | Troponin I increased
Item
as well as one of the following: ecg changes: new or presumably new st-segment depression greater than or equal to 0.1 mv (1 mm), or transient (< 30 minutes) st-segment elevation greater than or equal to 0.1 mv (1 mm) in at least 2 contiguous leads -abnormal cardiac enzymes within the 24 hours before enrollment, defined as elevated troponin i defined as elevated troponin i (above the normal reference -
boolean
C0855329 (UMLS CUI [1])
C0520887 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C0520886 (UMLS CUI [3,1])
C0205374 (UMLS CUI [3,2])
C0443763 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
C1141949 (UMLS CUI [5])
High risk Angiography Feature | Lesion | Bifurcation lesion of coronary artery | Left coronary artery Lesion | Multiple vessel coronary artery disease | Coronary artery Thrombus | Other Coding | Chronic total occlusion of coronary artery
Item
high-risk angiographic features :lesion/anatomy related bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, syntax score > 26 and chronic total occlusion disease.
boolean
C4319571 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
C2348519 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2])
C1299363 (UMLS CUI [3])
C1261082 (UMLS CUI [4,1])
C0221198 (UMLS CUI [4,2])
C3805196 (UMLS CUI [5])
C0205042 (UMLS CUI [6,1])
C0087086 (UMLS CUI [6,2])
C3846158 (UMLS CUI [7])
C1955779 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Bleeding risk Increased | Ischemic stroke | Brain hemorrhage | Hemorrhagic tumor | Intracranial Aneurysm Hemorrhagic
Item
increased bleeding risk: ischaemic stroke within the last year or any previous haemorrhagic stroke, tumour or intracranial aneurysm;
boolean
C3251812 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0948008 (UMLS CUI [2])
C0553692 (UMLS CUI [3])
C1300819 (UMLS CUI [4])
C0007766 (UMLS CUI [5,1])
C0333275 (UMLS CUI [5,2])
Trauma | Major surgery | Bypass surgery
Item
recent (<1 month) trauma or major surgery (including bypass surgery);
boolean
C3714660 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
C1536078 (UMLS CUI [3])
Hemorrhage
Item
active bleeding
boolean
C0019080 (UMLS CUI [1])
Hemorrhage Unexplained | Thrombocytopenia | Platelet Count measurement | Platelet glycoprotein IIb-IIIa | Heparin | Enoxaparin
Item
unexplained clinically significant bleeding, thrombocytopenia (platelet count < 100 x 109/l) or history of thrombocytopenia with gp iib/iiia, heparin or enoxaparin therapy
boolean
C0019080 (UMLS CUI [1,1])
C4288071 (UMLS CUI [1,2])
C0040034 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C1955352 (UMLS CUI [4])
C0019134 (UMLS CUI [5])
C0206460 (UMLS CUI [6])
Angina Pectoris Cause Secondary | Uncontrolled hypertension | Systolic Pressure
Item
angina from secondary causes such as severe uncontrolled hypertension (systolic blood pressure > 180 mm hg despite treatment)
boolean
C0002962 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0175668 (UMLS CUI [1,3])
C1868885 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
Valvular disease | Congenital heart disease | Hypertrophic Cardiomyopathy
Item
valvular disease, congenital heart disease, hypertrophic cardiomyopathy, -
boolean
C3258293 (UMLS CUI [1])
C0152021 (UMLS CUI [2])
C0007194 (UMLS CUI [3])
Thrombolytic Therapy
Item
thrombolytic therapy within preceding 24 hours
boolean
C0040044 (UMLS CUI [1])
Glycoprotein IIb/IIIa Antagonist
Item
receiving antiiib/iiia therapy
boolean
C3640054 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatinine clearance of <30 ml/min
boolean
C0373595 (UMLS CUI [1])
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