ID

38459

Description

PeriOperative ISchemic Evaluation-2 Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01082874

Link

https://clinicaltrials.gov/show/NCT01082874

Keywords

Versions (1)
  1. 10/19/19 10/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 19, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT01082874

English

Eligibility Cardiovascular Disease NCT01082874

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. are undergoing noncardiac surgery;
Description

Operative Surgical Procedure | Exception Cardiac Surgery procedure

Data type

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018821
2. are ≥ 45 years of age;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. are expected to require at least an overnight hospital admission after surgery; and
Description

Hospital admission Overnight Expected | Status post Operative Surgical Procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0439583
UMLS CUI [1,3]
C1517001
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0543467
4. fulfill one or more of the following 5 criteria:
Description

Criteria Quantity Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
history of coronary artery disease
Description

Coronary Artery Disease

Data type

boolean

Alias
UMLS CUI [1]
C1956346
history of peripheral vascular disease
Description

Peripheral Vascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0085096
history of stroke
Description

Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0038454
undergoing major vascular surgery
Description

Vascular Surgical Procedure Major

Data type

boolean

Alias
UMLS CUI [1,1]
C0042381
UMLS CUI [1,2]
C0205164
any 3 of the following 9 criteria:
Description

Criteria Quantity Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
undergoing major surgery (i.e. intraperitoneal, intrathoracic, retroperitoneal or major orthopedic surgery
Description

Major surgery | Operative Surgical Procedure Intraperitoneal | Thoracic Surgical Procedure | Operative Surgical Procedure Retroperitoneal | Orthopedic Surgical Procedure Major

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0442120
UMLS CUI [3]
C0524832
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0035359
UMLS CUI [5,1]
C1136201
UMLS CUI [5,2]
C0205164
history of congestive heart failure
Description

Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
transient ischemic attack
Description

Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0007787
diabetes and currently taking an oral hypoglycemic agent or insulin
Description

Diabetes Mellitus | Hypoglycemic Agent | Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0020616
UMLS CUI [3]
C0021641
age ≥ 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hypertension
Description

Hypertensive disease

Data type

boolean

Alias
UMLS CUI [1]
C0020538
serum creatinine > 175 µmol/l (> 2.0 mg/dl)
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
history of smoking within 2 years of surgery
Description

Tobacco use | Time period Operative Surgical Procedure

Data type

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2,1]
C1948053
UMLS CUI [2,2]
C0543467
undergoing urgent/emergent surgery
Description

Urgent surgical procedure | Emergency surgery

Data type

boolean

Alias
UMLS CUI [1]
C2188405
UMLS CUI [2]
C4264510
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. consumption of asa within 72 hours prior to surgery
Description

Intake ASA | Status pre- Operative Surgical Procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1512806
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0543467
2. hypersensitivity or known allergy to asa or clonidine
Description

Aspirin allergy | Clonidine allergy

Data type

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2]
C0570975
3. systolic blood pressure < 105 mm hg
Description

Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
4. heart rate < 55 beats per minute in a patient who does not have a permanent pacemaker
Description

Heart rate | Permanent pacemaker Absent

Data type

boolean

Alias
UMLS CUI [1]
C0018810
UMLS CUI [2,1]
C0281945
UMLS CUI [2,2]
C0332197
5. second or third degree heart block without a permanent pacemaker
Description

Second degree atrioventricular block | Complete atrioventricular block | Permanent pacemaker Absent

Data type

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3,1]
C0281945
UMLS CUI [3,2]
C0332197
6. active peptic ulcer disease or gastrointestinal bleeding within previous 6 weeks
Description

Peptic Ulcer | Gastrointestinal Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0017181
7. intracranial hemorrhage documented by neuro-imaging, in the 6 months prior to randomization. this does not include petechial hemorrhagic transformation of a primary ischemic stroke
Description

Intracranial Hemorrhage Neuroimaging | Exception Petechiae Haemorrhagic transformation stroke

Data type

boolean

Alias
UMLS CUI [1,1]
C0151699
UMLS CUI [1,2]
C0679575
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0031256
UMLS CUI [2,3]
C1096400
8. subarachnoid hemorrhage or epidural hematoma unless the event occurred more than 6 months prior to randomization and the offending aneurysm or arterial lesion has been repaired
Description

Subarachnoid Hemorrhage | Hematoma, Epidural | Exception Aneurysm Repaired | Exception Lesion Arterial Repaired

Data type

boolean

Alias
UMLS CUI [1]
C0038525
UMLS CUI [2]
C0238154
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0002940
UMLS CUI [3,3]
C0205340
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0221198
UMLS CUI [4,3]
C0221464
UMLS CUI [4,4]
C0205340
9. drug-eluting coronary stent in the year prior to randomization
Description

Drug-Eluting Coronary Stent

Data type

boolean

Alias
UMLS CUI [1]
C1262327
10. bare-metal coronary stent in the 6 weeks prior to randomization
Description

Bare-metal coronary artery stent

Data type

boolean

Alias
UMLS CUI [1]
C1736419
11. thienopyridine (e.g., clopidogrel, ticlopidine, prasugrel) or ticagrelor within 72 hours prior to surgery; or intent to restart a thienopyridine or ticagrelor during the first 7 days post-op; or currently taking an alpha-2 agonist, alpha methyldopa, monoamine oxidase inhibitors or reserpine;
Description

Thienopyridines | clopidogrel | Ticlopidine | prasugrel | Ticagrelor | alpha-2 Agonists | Methyldopa | Monoamine Oxidase Inhibitors | Reserpine

Data type

boolean

Alias
UMLS CUI [1]
C2936588
UMLS CUI [2]
C0070166
UMLS CUI [3]
C0040207
UMLS CUI [4]
C1620287
UMLS CUI [5]
C1999375
UMLS CUI [6]
C2746076
UMLS CUI [7]
C0025741
UMLS CUI [8]
C0026457
UMLS CUI [9]
C0035179
12. planned use - during the first 3 days after surgery - therapeutic dose anticoagulation or a therapeutic subcutaneous or intravenous antithrombotic agent
Description

Use of anticoagulation Dose Therapeutic Planned | Fibrinolytic Agents Subcutaneous Planned | Fibrinolytic Agents Intravenous Planned | Status post Operative Surgical Procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0449867
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0302350
UMLS CUI [1,4]
C1301732
UMLS CUI [2,1]
C0016018
UMLS CUI [2,2]
C1522438
UMLS CUI [2,3]
C1301732
UMLS CUI [3,1]
C0016018
UMLS CUI [3,2]
C1522726
UMLS CUI [3,3]
C1301732
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0543467
13. undergoing intracranial surgery, carotid endarterectomy, or retinal surgery
Description

Intracranial surgery | Carotid Endarterectomy | Operation on retina

Data type

boolean

Alias
UMLS CUI [1]
C0745377
UMLS CUI [2]
C0014099
UMLS CUI [3]
C0197770
14. not consenting to participate in poise-2 prior to surgery
Description

Refusal to Participate Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C1136454
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
15. previously enrolled in poise-2 trial
Description

Study Subject Participation Status | Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
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Similar models

Eligibility Cardiovascular Disease NCT01082874

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Operative Surgical Procedure | Exception Cardiac Surgery procedure
Item
1. are undergoing noncardiac surgery;
boolean
C0543467 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0018821 (UMLS CUI [2,2])
Age
Item
2. are ≥ 45 years of age;
boolean
C0001779 (UMLS CUI [1])
Hospital admission Overnight Expected | Status post Operative Surgical Procedure
Item
3. are expected to require at least an overnight hospital admission after surgery; and
boolean
C0184666 (UMLS CUI [1,1])
C0439583 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
Criteria Quantity Fulfill
Item
4. fulfill one or more of the following 5 criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Coronary Artery Disease
Item
history of coronary artery disease
boolean
C1956346 (UMLS CUI [1])
Peripheral Vascular Disease
Item
history of peripheral vascular disease
boolean
C0085096 (UMLS CUI [1])
Cerebrovascular accident
Item
history of stroke
boolean
C0038454 (UMLS CUI [1])
Vascular Surgical Procedure Major
Item
undergoing major vascular surgery
boolean
C0042381 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Criteria Quantity Fulfill
Item
any 3 of the following 9 criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Major surgery | Operative Surgical Procedure Intraperitoneal | Thoracic Surgical Procedure | Operative Surgical Procedure Retroperitoneal | Orthopedic Surgical Procedure Major
Item
undergoing major surgery (i.e. intraperitoneal, intrathoracic, retroperitoneal or major orthopedic surgery
boolean
C0679637 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0442120 (UMLS CUI [2,2])
C0524832 (UMLS CUI [3])
C0543467 (UMLS CUI [4,1])
C0035359 (UMLS CUI [4,2])
C1136201 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
Congestive heart failure
Item
history of congestive heart failure
boolean
C0018802 (UMLS CUI [1])
Transient Ischemic Attack
Item
transient ischemic attack
boolean
C0007787 (UMLS CUI [1])
Diabetes Mellitus | Hypoglycemic Agent | Insulin
Item
diabetes and currently taking an oral hypoglycemic agent or insulin
boolean
C0011849 (UMLS CUI [1])
C0020616 (UMLS CUI [2])
C0021641 (UMLS CUI [3])
Age
Item
age ≥ 70 years
boolean
C0001779 (UMLS CUI [1])
Hypertensive disease
Item
hypertension
boolean
C0020538 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine > 175 µmol/l (> 2.0 mg/dl)
boolean
C0201976 (UMLS CUI [1])
Tobacco use | Time period Operative Surgical Procedure
Item
history of smoking within 2 years of surgery
boolean
C0543414 (UMLS CUI [1])
C1948053 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
Urgent surgical procedure | Emergency surgery
Item
undergoing urgent/emergent surgery
boolean
C2188405 (UMLS CUI [1])
C4264510 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Intake ASA | Status pre- Operative Surgical Procedure
Item
1. consumption of asa within 72 hours prior to surgery
boolean
C1512806 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
Aspirin allergy | Clonidine allergy
Item
2. hypersensitivity or known allergy to asa or clonidine
boolean
C0004058 (UMLS CUI [1])
C0570975 (UMLS CUI [2])
Systolic Pressure
Item
3. systolic blood pressure < 105 mm hg
boolean
C0871470 (UMLS CUI [1])
Heart rate | Permanent pacemaker Absent
Item
4. heart rate < 55 beats per minute in a patient who does not have a permanent pacemaker
boolean
C0018810 (UMLS CUI [1])
C0281945 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Second degree atrioventricular block | Complete atrioventricular block | Permanent pacemaker Absent
Item
5. second or third degree heart block without a permanent pacemaker
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0281945 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Peptic Ulcer | Gastrointestinal Hemorrhage
Item
6. active peptic ulcer disease or gastrointestinal bleeding within previous 6 weeks
boolean
C0030920 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
Intracranial Hemorrhage Neuroimaging | Exception Petechiae Haemorrhagic transformation stroke
Item
7. intracranial hemorrhage documented by neuro-imaging, in the 6 months prior to randomization. this does not include petechial hemorrhagic transformation of a primary ischemic stroke
boolean
C0151699 (UMLS CUI [1,1])
C0679575 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0031256 (UMLS CUI [2,2])
C1096400 (UMLS CUI [2,3])
Subarachnoid Hemorrhage | Hematoma, Epidural | Exception Aneurysm Repaired | Exception Lesion Arterial Repaired
Item
8. subarachnoid hemorrhage or epidural hematoma unless the event occurred more than 6 months prior to randomization and the offending aneurysm or arterial lesion has been repaired
boolean
C0038525 (UMLS CUI [1])
C0238154 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0002940 (UMLS CUI [3,2])
C0205340 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0221198 (UMLS CUI [4,2])
C0221464 (UMLS CUI [4,3])
C0205340 (UMLS CUI [4,4])
Drug-Eluting Coronary Stent
Item
9. drug-eluting coronary stent in the year prior to randomization
boolean
C1262327 (UMLS CUI [1])
Bare-metal coronary artery stent
Item
10. bare-metal coronary stent in the 6 weeks prior to randomization
boolean
C1736419 (UMLS CUI [1])
Thienopyridines | clopidogrel | Ticlopidine | prasugrel | Ticagrelor | alpha-2 Agonists | Methyldopa | Monoamine Oxidase Inhibitors | Reserpine
Item
11. thienopyridine (e.g., clopidogrel, ticlopidine, prasugrel) or ticagrelor within 72 hours prior to surgery; or intent to restart a thienopyridine or ticagrelor during the first 7 days post-op; or currently taking an alpha-2 agonist, alpha methyldopa, monoamine oxidase inhibitors or reserpine;
boolean
C2936588 (UMLS CUI [1])
C0070166 (UMLS CUI [2])
C0040207 (UMLS CUI [3])
C1620287 (UMLS CUI [4])
C1999375 (UMLS CUI [5])
C2746076 (UMLS CUI [6])
C0025741 (UMLS CUI [7])
C0026457 (UMLS CUI [8])
C0035179 (UMLS CUI [9])
Use of anticoagulation Dose Therapeutic Planned | Fibrinolytic Agents Subcutaneous Planned | Fibrinolytic Agents Intravenous Planned | Status post Operative Surgical Procedure
Item
12. planned use - during the first 3 days after surgery - therapeutic dose anticoagulation or a therapeutic subcutaneous or intravenous antithrombotic agent
boolean
C0449867 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0302350 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
C0016018 (UMLS CUI [2,1])
C1522438 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0016018 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
C0231290 (UMLS CUI [4,1])
C0543467 (UMLS CUI [4,2])
Intracranial surgery | Carotid Endarterectomy | Operation on retina
Item
13. undergoing intracranial surgery, carotid endarterectomy, or retinal surgery
boolean
C0745377 (UMLS CUI [1])
C0014099 (UMLS CUI [2])
C0197770 (UMLS CUI [3])
Refusal to Participate Clinical Trial Specified
Item
14. not consenting to participate in poise-2 prior to surgery
boolean
C1136454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Study Subject Participation Status | Clinical Trial Specified
Item
15. previously enrolled in poise-2 trial
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
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