ID

5712

Description

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00153062

Link

http://clinicaltrials.gov/ct2/show/record/NCT00153062

Keywords

  1. 11/24/11 11/24/11 -
  2. 4/13/14 4/13/14 - Julian Varghese
  3. 8/11/14 8/11/14 - Martin Dugas
  4. 8/11/14 8/11/14 - Martin Dugas
Uploaded on

August 11, 2014

DOI

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License

Creative Commons BY 4.0

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Eligibility NCT00153062 Stroke

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
50 Years and older
Description

Age

Data type

boolean

Alias
UMLS CUI-1
C0001779
Male or female subjects 55 year or older who have suffered an ischemic stroke within the past 90 days and who meet all other inclusion criteria. Include also patients of ages 50 - 54 years and/or 90 to 120 days after the qualifying stroke provided the patient has at least two of the following additional risk factors: Diabetes mellitus, Hypertension (systolic blood pressure (BP)>=140 millimeters of Mercury (mmHg) or diastolic BP>=90mmHg), Smoker at time of qualifying stroke, Obesity (Body mass index (BMI)>30, BMI=weight in kilograms (kg)/[height in meters (m)]2), Previous vascular disease (stroke, MI, or peripheral arterial disease prior to qualifying stroke), End-organ-damage (retinopathy, left ventricular hypertrophy (LVH), or microalbuminuria), Hyperlipidemia
Description

Male or female subjects 55 year or older who have suffered an ischemic stroke within the past 90 days and who meet all other inclusion criteria. Include also patients of ages 50 - 54 years and/or 90 to 120 days after the qualifying stroke provided the patient has at least two of the following additional risk factors: Diabetes mellitus, Hypertension (systolic blood pressure (BP)>=140 millimeters of Mercury (mmHg) or diastolic BP>=90mmHg), Smoker at time of qualifying stroke, Obesity (Body mass index (BMI)>30, BMI=weight in kilograms (kg)/[height in meters (m)]2), Previous vascular disease (stroke, MI, or peripheral arterial disease prior to qualifying stroke), End-organ-damage (retinopathy, left ventricular hypertrophy (LVH), or microalbuminuria), Hyperlipidemia

Data type

boolean

Alias
UMLS CUI-1
C0948008
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
hemorrhagic stroke (must be ruled out by imaging)
Description

hemorrhagic stroke (must be ruled out by imaging)

Data type

boolean

Alias
UMLS CUI-1
C0553692
unable to give informed consent
Description

unable to give informed consent

Data type

boolean

Alias
UMLS CUI-1
C1299582
UMLS CUI-2
C0021430
known brain tumor, severe renal or hepatic insufficiency, current active peptic ulcer disease, severe coronary artery disease including unstable angina pectoris or an MI within the previous 3 months,or history of a hemostatic disorder or systemic bleeding
Description

other diseases

Data type

boolean

hyperkalemia, uncorrected volume or sodium depletion
Description

hyperkalemia, uncorrected volume or sodium depletion

Data type

boolean

Alias
UMLS CUI-1
C0020461
pre-stroke history of dementia, modified Rankin score greater than 4
Description

pre-stroke history of dementia

Data type

boolean

qualifying stroke induced by surgical or cardiovascular procedure
Description

qualifying stroke induced by surgical or cardiovascular procedure

Data type

boolean

uncontrolled hypertension at entry above 180/110 mmHg (goal blood pressures are lower)
Description

uncontrolled hypertension

Data type

boolean

Systolic blood pressure (SBP) 120 mmHg or less for hospitalized patients. Currently taking an Angiotensin II receptor blocker (ARB) and not able or willing to switch to alternative. Required or planned continuing treatment with antithrombotics or anticoagulants including heparin or warfarin or non-study platelet inhibitors
Description

Blood pressure, ARB therapy, anticoagulation

Data type

boolean

syndrome of asthma, rhinitis and nasal polyps
Description

syndrome of asthma, rhinitis and nasal polyps

Data type

boolean

scheduled for major surgery, carotid endarterectomy, or carotid angioplasty (4 weeks post surgery is allowed)
Description

scheduled for major surgery

Data type

boolean

unlikely to be released from hospital following the qualifying stroke or presence of a severe disability likely to lead to being bedridden or demented or a non-vascular disease or condition which makes it unlikely that the patient will survive to the end of the trial
Description

unlikely to be released from hospital

Data type

boolean

history of thrombocytopenia or neutropenia
Description

history of thrombocytopenia or neutropenia

Data type

boolean

Medical concepts
Description

Medical concepts

Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Ischemic stroke
Description

Ischemic stroke

Data type

string

Alias
UMLS CUI
C0948008
SNOMED CT 2010_0731
422504002
MedDRA 13.1
10055221
Diabetes mellitus
Description

Diabetes mellitus

Data type

string

Alias
UMLS CUI
C0011849
SNOMED CT 2010_0731
191044006
Hypertensive disease
Description

Hypertension

Data type

string

Alias
UMLS CUI
C0020538
SNOMED CT 2010_0731
38341003
MedDRA 13.1
10020772
LOINC Version 232
MTHU020789
ICD-10-CM Version 2010
I10
ICD-9-CM Version 2011
997.91
CTCAE Version 4.03
E13785
Smoking Status
Description

Smoking Status

Data type

text

Alias
UMLS CUI-1
C1519386
Obesity
Description

Obesity

Data type

string

Alias
UMLS CUI
C0028754
SNOMED CT 2010_0731
414916001
MedDRA 13.1
10029883
ICD-10-CM Version 2010
E66.0
ICD-9-CM Version 2011
278.00
CTCAE Version 4.03
E12361
Body mass index
Description

BMI

Data type

string

Alias
UMLS CUI
C1305855
SNOMED CT 2010_0731
140075008
MedDRA 13.1
10005894
LOINC Version 232
LP35925-4
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Stroke
Description

Stroke

Data type

string

Alias
UMLS CUI
C0038454
SNOMED CT 2010_0731
230690007
MedDRA 13.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE Version 4.03
E12826
Acute myocardial infarction
Description

Acute myocardial infarction

Data type

string

Alias
UMLS CUI
C0155626
SNOMED CT 2010_0731
57054005
MedDRA 13.1
10000891
ICD-10-CM Version 2010
I21
ICD-9-CM Version 2011
410
Peripheral Arterial Diseases
Description

PAD

Data type

string

Alias
UMLS CUI
C1704436
SNOMED CT 2010_0731
399957001
MedDRA 13.1
10067825
Retinopathy
Description

Retinopathy

Data type

string

Alias
UMLS CUI
C0035309
SNOMED CT 2010_0731
399625000
MedDRA 13.1
10038923
CTCAE Version 4.03
E10432
Left Ventricular Hypertrophy
Description

LVH

Data type

string

Alias
UMLS CUI
C0149721
SNOMED CT 2010_0731
55827005
MedDRA 13.1
10049773
Microalbuminuria
Description

Microalbuminuria

Data type

string

Alias
UMLS CUI
C0730345
SNOMED CT 2010_0731
312975006
MedDRA 13.1
10027525
Hyperlipidemia
Description

Hyperlipidaemia

Data type

string

Alias
UMLS CUI
C0020473
SNOMED CT 2010_0731
55822004
MedDRA 13.1
10062060
ICD-10-CM Version 2010
E78.5
Brain hemorrhage
Description

Haemorrhagic stroke

Data type

string

Alias
UMLS CUI
C0553692
SNOMED CT 2010_0731
230706003
MedDRA 13.1
10019016
Brain Neoplasms
Description

Brain tumor

Data type

string

Alias
UMLS CUI
C0006118
SNOMED CT 2010_0731
126952004
MedDRA 13.1
10061019
ICD-9-CM Version 2011
239.6
Renal Insufficiency
Description

Kidney Insufficiency

Data type

string

Alias
UMLS CUI
C1565489
MedDRA 13.1
10038474
Hepatic Insufficiency
Description

Liver Insufficiency

Data type

string

Alias
UMLS CUI
C1306571
SNOMED CT 2010_0731
59927004
MedDRA 13.1
10056542
Peptic Ulcer
Description

Gastroduodenal ulcer

Data type

string

Alias
UMLS CUI
C0030920
SNOMED CT 2010_0731
13200003
MedDRA 13.1
10034341
ICD-10-CM Version 2010
K27
ICD-9-CM Version 2011
533
Coronary artery disease (CAD)
Description

Coronary Heart Disease (CHD)

Data type

string

Alias
UMLS CUI
C0010068
SNOMED CT 2010_0731
53741008
MedDRA 13.1
10068617
Bleeding tendency
Description

Bleeding diathesis

Data type

string

Alias
UMLS CUI
C0005779
SNOMED CT 2010_0731
248250000
MedDRA 13.1
10005134
hyperkalemia
Description

Hyperpotassemia

Data type

string

Alias
UMLS CUI
C0020461
SNOMED CT 2010_0731
14140009
MedDRA 13.1
10020646
ICD-10-CM Version 2010
E87.5
ICD-9-CM Version 2011
276.7
CTCAE Version 4.03
E12282
Dementia
Description

Dementia

Data type

string

Alias
UMLS CUI
C0497327
SNOMED CT 2010_0731
52448006
MedDRA 13.1
10012267
ICD-10-CM Version 2010
F03
ICD-9-CM Version 2011
290
Rankin score
Description

Rankin score

Data type

string

Alias
UMLS CUI
CL423500
Complication of surgical and medical care, unspecified
Description

Complications of medical and surgical care

Data type

string

Alias
UMLS CUI
C0274310
ICD-10-CM Version 2010
T88.9, Y62-Y84
Systolic Blood Pressure
Description

Systolic Pressure

Data type

string

Alias
UMLS CUI
C0871470
SNOMED CT 2010_0731
271649006
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
Angiotensin II receptor antagonist
Description

Angiotensin II Receptor Blocker (ARB)

Data type

string

Alias
UMLS CUI
C0521942
SNOMED CT 2010_0731
372913009
Anticoagulant treatment
Description

Anticoagulant therapy

Data type

string

Alias
UMLS CUI
C0150457
SNOMED CT 2010_0731
182764009
MedDRA 13.1
10053468
Antithrombic Drugs
Description

Antithrombotic Agents

Data type

string

Alias
UMLS CUI
C1704311
Heparin
Description

Heparin

Data type

string

Alias
UMLS CUI
C0019134
SNOMED CT 2010_0731
372877000
LOINC Version 232
MTHU003766
Warfarin
Description

Warfarin

Data type

string

Alias
UMLS CUI
C0043031
SNOMED CT 2010_0731
48603004
LOINC Version 232
MTHU003212
Therapeutic procedure
Description

Therapeutic procedure

Data type

string

Alias
UMLS CUI
C0087111
Asthma
Description

Bronchial Asthma

Data type

string

Alias
UMLS CUI
C0004096
SNOMED CT 2010_0731
195967001
MedDRA 13.1
10003553
LOINC Version 232
MTHU020815
ICD-10-CM Version 2010
J45
ICD-9-CM Version 2011
493
Life expectancy
Description

Life expectancy

Data type

string

Alias
UMLS CUI
C0023671
LOINC Version 232
LP75025-4
Platelet count - finding
Description

Platelet count

Data type

string

Alias
UMLS CUI
C1287267
SNOMED CT 2010_0731
365632008
LOINC Version 232
777-3
White Blood Cells
Description

WBC

Data type

string

Alias
UMLS CUI
C0023508
SNOMED CT 2010_0731
767002
LOINC Version 232
6690-2
Neutropenia
Description

Neutrophil count decreased

Data type

string

Alias
UMLS CUI
C0853697
MedDRA 13.1
10029366
CTCAE Version 4.03
E12198
Thrombocytopenia
Description

Thrombopenia

Data type

string

Alias
UMLS CUI
C0040034
SNOMED CT 2010_0731
302215000
MedDRA 13.1
10043554
ICD-10-CM Version 2010
D69.6
ICD-9-CM Version 2011
287.5
CTCAE Version 4.03
E12207

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
50 Years and older
boolean
C0001779 (UMLS CUI-1)
Ischemic stroke
Item
Male or female subjects 55 year or older who have suffered an ischemic stroke within the past 90 days and who meet all other inclusion criteria. Include also patients of ages 50 - 54 years and/or 90 to 120 days after the qualifying stroke provided the patient has at least two of the following additional risk factors: Diabetes mellitus, Hypertension (systolic blood pressure (BP)>=140 millimeters of Mercury (mmHg) or diastolic BP>=90mmHg), Smoker at time of qualifying stroke, Obesity (Body mass index (BMI)>30, BMI=weight in kilograms (kg)/[height in meters (m)]2), Previous vascular disease (stroke, MI, or peripheral arterial disease prior to qualifying stroke), End-organ-damage (retinopathy, left ventricular hypertrophy (LVH), or microalbuminuria), Hyperlipidemia
boolean
C0948008 (UMLS CUI-1)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
hemorrhagic stroke
Item
hemorrhagic stroke (must be ruled out by imaging)
boolean
C0553692 (UMLS CUI-1)
unable to give informed consent
Item
unable to give informed consent
boolean
C1299582 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
other diseases
Item
known brain tumor, severe renal or hepatic insufficiency, current active peptic ulcer disease, severe coronary artery disease including unstable angina pectoris or an MI within the previous 3 months,or history of a hemostatic disorder or systemic bleeding
boolean
hyperkalemia
Item
hyperkalemia, uncorrected volume or sodium depletion
boolean
C0020461 (UMLS CUI-1)
pre-stroke history of dementia
Item
pre-stroke history of dementia, modified Rankin score greater than 4
boolean
qualifying stroke induced by surgical or cardiovascular procedure
Item
qualifying stroke induced by surgical or cardiovascular procedure
boolean
uncontrolled hypertension
Item
uncontrolled hypertension at entry above 180/110 mmHg (goal blood pressures are lower)
boolean
Blood pressure, ARB therapy, anticoagulation
Item
Systolic blood pressure (SBP) 120 mmHg or less for hospitalized patients. Currently taking an Angiotensin II receptor blocker (ARB) and not able or willing to switch to alternative. Required or planned continuing treatment with antithrombotics or anticoagulants including heparin or warfarin or non-study platelet inhibitors
boolean
syndrome of asthma, rhinitis and nasal polyps
Item
syndrome of asthma, rhinitis and nasal polyps
boolean
scheduled for major surgery
Item
scheduled for major surgery, carotid endarterectomy, or carotid angioplasty (4 weeks post surgery is allowed)
boolean
unlikely to be released from hospital
Item
unlikely to be released from hospital following the qualifying stroke or presence of a severe disability likely to lead to being bedridden or demented or a non-vascular disease or condition which makes it unlikely that the patient will survive to the end of the trial
boolean
history of thrombocytopenia or neutropenia
Item
history of thrombocytopenia or neutropenia
boolean
Item Group
Medical concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Ischemic stroke
Item
Ischemic stroke
string
C0948008 (UMLS CUI)
422504002 (SNOMED CT 2010_0731)
10055221 (MedDRA 13.1)
Diabetes mellitus
Item
Diabetes mellitus
string
C0011849 (UMLS CUI)
191044006 (SNOMED CT 2010_0731)
Hypertension
Item
Hypertensive disease
string
C0020538 (UMLS CUI)
38341003 (SNOMED CT 2010_0731)
10020772 (MedDRA 13.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE Version 4.03)
Smoking Status
Item
Smoking Status
text
C1519386 (UMLS CUI-1)
Obesity
Item
Obesity
string
C0028754 (UMLS CUI)
414916001 (SNOMED CT 2010_0731)
10029883 (MedDRA 13.1)
E66.0 (ICD-10-CM Version 2010)
278.00 (ICD-9-CM Version 2011)
E12361 (CTCAE Version 4.03)
BMI
Item
Body mass index
string
C1305855 (UMLS CUI)
140075008 (SNOMED CT 2010_0731)
10005894 (MedDRA 13.1)
LP35925-4 (LOINC Version 232)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Stroke
Item
Stroke
string
C0038454 (UMLS CUI)
230690007 (SNOMED CT 2010_0731)
10042244 (MedDRA 13.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE Version 4.03)
Acute myocardial infarction
Item
Acute myocardial infarction
string
C0155626 (UMLS CUI)
57054005 (SNOMED CT 2010_0731)
10000891 (MedDRA 13.1)
I21 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
PAD
Item
Peripheral Arterial Diseases
string
C1704436 (UMLS CUI)
399957001 (SNOMED CT 2010_0731)
10067825 (MedDRA 13.1)
Retinopathy
Item
Retinopathy
string
C0035309 (UMLS CUI)
399625000 (SNOMED CT 2010_0731)
10038923 (MedDRA 13.1)
E10432 (CTCAE Version 4.03)
LVH
Item
Left Ventricular Hypertrophy
string
C0149721 (UMLS CUI)
55827005 (SNOMED CT 2010_0731)
10049773 (MedDRA 13.1)
Microalbuminuria
Item
Microalbuminuria
string
C0730345 (UMLS CUI)
312975006 (SNOMED CT 2010_0731)
10027525 (MedDRA 13.1)
Hyperlipidaemia
Item
Hyperlipidemia
string
C0020473 (UMLS CUI)
55822004 (SNOMED CT 2010_0731)
10062060 (MedDRA 13.1)
E78.5 (ICD-10-CM Version 2010)
Haemorrhagic stroke
Item
Brain hemorrhage
string
C0553692 (UMLS CUI)
230706003 (SNOMED CT 2010_0731)
10019016 (MedDRA 13.1)
Brain tumor
Item
Brain Neoplasms
string
C0006118 (UMLS CUI)
126952004 (SNOMED CT 2010_0731)
10061019 (MedDRA 13.1)
239.6 (ICD-9-CM Version 2011)
Kidney Insufficiency
Item
Renal Insufficiency
string
C1565489 (UMLS CUI)
10038474 (MedDRA 13.1)
Liver Insufficiency
Item
Hepatic Insufficiency
string
C1306571 (UMLS CUI)
59927004 (SNOMED CT 2010_0731)
10056542 (MedDRA 13.1)
Gastroduodenal ulcer
Item
Peptic Ulcer
string
C0030920 (UMLS CUI)
13200003 (SNOMED CT 2010_0731)
10034341 (MedDRA 13.1)
K27 (ICD-10-CM Version 2010)
533 (ICD-9-CM Version 2011)
Coronary Heart Disease (CHD)
Item
Coronary artery disease (CAD)
string
C0010068 (UMLS CUI)
53741008 (SNOMED CT 2010_0731)
10068617 (MedDRA 13.1)
Bleeding diathesis
Item
Bleeding tendency
string
C0005779 (UMLS CUI)
248250000 (SNOMED CT 2010_0731)
10005134 (MedDRA 13.1)
Hyperpotassemia
Item
hyperkalemia
string
C0020461 (UMLS CUI)
14140009 (SNOMED CT 2010_0731)
10020646 (MedDRA 13.1)
E87.5 (ICD-10-CM Version 2010)
276.7 (ICD-9-CM Version 2011)
E12282 (CTCAE Version 4.03)
Dementia
Item
Dementia
string
C0497327 (UMLS CUI)
52448006 (SNOMED CT 2010_0731)
10012267 (MedDRA 13.1)
F03 (ICD-10-CM Version 2010)
290 (ICD-9-CM Version 2011)
Rankin score
Item
Rankin score
string
CL423500 (UMLS CUI)
Complications of medical and surgical care
Item
Complication of surgical and medical care, unspecified
string
C0274310 (UMLS CUI)
T88.9, Y62-Y84 (ICD-10-CM Version 2010)
Systolic Pressure
Item
Systolic Blood Pressure
string
C0871470 (UMLS CUI)
271649006 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Angiotensin II Receptor Blocker (ARB)
Item
Angiotensin II receptor antagonist
string
C0521942 (UMLS CUI)
372913009 (SNOMED CT 2010_0731)
Anticoagulant therapy
Item
Anticoagulant treatment
string
C0150457 (UMLS CUI)
182764009 (SNOMED CT 2010_0731)
10053468 (MedDRA 13.1)
Antithrombotic Agents
Item
Antithrombic Drugs
string
C1704311 (UMLS CUI)
Heparin
Item
Heparin
string
C0019134 (UMLS CUI)
372877000 (SNOMED CT 2010_0731)
MTHU003766 (LOINC Version 232)
Warfarin
Item
Warfarin
string
C0043031 (UMLS CUI)
48603004 (SNOMED CT 2010_0731)
MTHU003212 (LOINC Version 232)
Therapeutic procedure
Item
Therapeutic procedure
string
C0087111 (UMLS CUI)
Bronchial Asthma
Item
Asthma
string
C0004096 (UMLS CUI)
195967001 (SNOMED CT 2010_0731)
10003553 (MedDRA 13.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
Life expectancy
Item
Life expectancy
string
C0023671 (UMLS CUI)
LP75025-4 (LOINC Version 232)
Platelet count
Item
Platelet count - finding
string
C1287267 (UMLS CUI)
365632008 (SNOMED CT 2010_0731)
777-3 (LOINC Version 232)
WBC
Item
White Blood Cells
string
C0023508 (UMLS CUI)
767002 (SNOMED CT 2010_0731)
6690-2 (LOINC Version 232)
Neutrophil count decreased
Item
Neutropenia
string
C0853697 (UMLS CUI)
10029366 (MedDRA 13.1)
E12198 (CTCAE Version 4.03)
Thrombopenia
Item
Thrombocytopenia
string
C0040034 (UMLS CUI)
302215000 (SNOMED CT 2010_0731)
10043554 (MedDRA 13.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
E12207 (CTCAE Version 4.03)

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