ID

27590

Description

PeriOperative ISchemic Evaluation-2 Pilot; ODM derived from: https://clinicaltrials.gov/show/NCT00860925

Link

https://clinicaltrials.gov/show/NCT00860925

Keywords

Versions (2)
  1. 11/21/17 11/21/17 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 21, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00860925

English

Eligibility Cardiovascular Disease NCT00860925

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients undergoing noncardiac surgery who fulfill the following criteria:
Description

Operative Surgical Procedures | Exception Cardiac Surgery

Data type

boolean

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

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
expected to require at least an overnight hospital admission after noncardiac surgery, and fulfill any 1 of the following criteria:
Description

Hospital admission Overnight Postoperative Expected | Operative Surgical Procedures | Exception Cardiac Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0439583
UMLS CUI [1,3]
C0032790
UMLS CUI [1,4]
C1517001
UMLS CUI [2]
C0543467
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0018821
history of coronary artery disease
Description

Coronary Artery Disease

Data type

boolean

Alias
UMLS CUI [1]
C1956346
peripheral vascular disease
Description

Peripheral Vascular Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0085096
stroke
Description

Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0038454
undergoing major vascular surgery (i.e., vascular surgery except arteriovenous shunt, vein stripping procedures, and carotid endarterectomies)
Description

Vascular Surgical Procedures Major | Vascular Surgical Procedures | Exception Arteriovenous shunt | Exception Stripping of vein | Exception Carotid Endarterectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0042381
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0042381
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0684204
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0149807
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0014099
or any 3 of 9 risk criteria:
Description

Risk Criteria Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1265611
1. undergoing major surgery [i.e., intraperitoneal, intrathoracic, or orthopedic surgery]
Description

Major surgery | Operative Surgical Procedures Intraperitoneal | Thoracic Surgical Procedures | Orthopedic Surgical Procedures

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]
C1136201
2. history of congestive heart failure
Description

Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
3. transient ischemic attack
Description

Transient Ischemic Attack

Data type

boolean

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

Diabetes Mellitus | Oral hypoglycemic | Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0359086
UMLS CUI [3]
C0021641
5. age = or > than 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
6. hypertension
Description

Hypertensive disease

Data type

boolean

Alias
UMLS CUI [1]
C0020538
7. serum creatinine > 175 µmol/l
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
8. history of smoking within 2 years of surgery, or
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
9. undergoing emergent/urgent surgery
Description

Emergency surgery

Data type

boolean

Alias
UMLS CUI [1]
C4264510
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients has taken asa < or = to 72 hours before scheduled surgery
Description

Aspirin

Data type

boolean

Alias
UMLS CUI [1]
C0004057
history of asa or clonidine hypersensitivity or allergy
Description

Aspirin allergy | Clonidine allergy

Data type

boolean

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

Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
heart rate < 55 beats per minute
Description

Heart rate

Data type

boolean

Alias
UMLS CUI [1]
C0018810
second or third degree heart block without a pacemaker
Description

Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent

Data type

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3,1]
C0030163
UMLS CUI [3,2]
C0332197
patient has active peptic ulcer disease
Description

Peptic Ulcer

Data type

boolean

Alias
UMLS CUI [1]
C0030920
patient has had a bare metal stent in the six weeks prior to randomization
Description

Bare metal stent

Data type

boolean

Alias
UMLS CUI [1]
C2825200
patient has had a drug eluting stent in the year prior to randomization
Description

Drug-Eluting Stents

Data type

boolean

Alias
UMLS CUI [1]
C1322815
patient is currently taking an alpha-2 agonist, alpha methyldopa, reserpine, clopidogrel, or ticlopidine
Description

Alpha 2 agonist | alpha-methyldopa | Reserpine | clopidogrel | Ticlopidine

Data type

boolean

Alias
UMLS CUI [1]
C1268904
UMLS CUI [2]
C0025741
UMLS CUI [3]
C0035179
UMLS CUI [4]
C0070166
UMLS CUI [5]
C0040207
patient 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
surgeon unwilling to have patient participate in a participate in a perioperative clonidine/asa trial
Description

Study Subject Participation Status Surgeon Unwilling | Clonidine Trial perioperative | Aspirin Trial perioperative

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0582175
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0009014
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C1518988
UMLS CUI [3,1]
C0004057
UMLS CUI [3,2]
C0008976
UMLS CUI [3,3]
C1518988
prior enrolment in the poise-2 pilot trial
Description

Enrollment Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
unable to obtain or refusal to consent prior to surgery
Description

Informed Consent Unable | Informed Consent Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1705116
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Similar models

Eligibility Cardiovascular Disease NCT00860925

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Operative Surgical Procedures | Exception Cardiac Surgery
Item
patients undergoing noncardiac surgery who fulfill the following criteria:
boolean
C0543467 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0018821 (UMLS CUI [2,2])
Age
Item
age ≥ 45 years
boolean
C0001779 (UMLS CUI [1])
Hospital admission Overnight Postoperative Expected | Operative Surgical Procedures | Exception Cardiac Surgery
Item
expected to require at least an overnight hospital admission after noncardiac surgery, and fulfill any 1 of the following criteria:
boolean
C0184666 (UMLS CUI [1,1])
C0439583 (UMLS CUI [1,2])
C0032790 (UMLS CUI [1,3])
C1517001 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0018821 (UMLS CUI [3,2])
Coronary Artery Disease
Item
history of coronary artery disease
boolean
C1956346 (UMLS CUI [1])
Peripheral Vascular Diseases
Item
peripheral vascular disease
boolean
C0085096 (UMLS CUI [1])
Cerebrovascular accident
Item
stroke
boolean
C0038454 (UMLS CUI [1])
Vascular Surgical Procedures Major | Vascular Surgical Procedures | Exception Arteriovenous shunt | Exception Stripping of vein | Exception Carotid Endarterectomy
Item
undergoing major vascular surgery (i.e., vascular surgery except arteriovenous shunt, vein stripping procedures, and carotid endarterectomies)
boolean
C0042381 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0042381 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0684204 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0149807 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0014099 (UMLS CUI [5,2])
Risk Criteria Quantity
Item
or any 3 of 9 risk criteria:
boolean
C0035647 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Major surgery | Operative Surgical Procedures Intraperitoneal | Thoracic Surgical Procedures | Orthopedic Surgical Procedures
Item
1. undergoing major surgery [i.e., intraperitoneal, intrathoracic, or orthopedic surgery]
boolean
C0679637 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0442120 (UMLS CUI [2,2])
C0524832 (UMLS CUI [3])
C1136201 (UMLS CUI [4])
Congestive heart failure
Item
2. history of congestive heart failure
boolean
C0018802 (UMLS CUI [1])
Transient Ischemic Attack
Item
3. transient ischemic attack
boolean
C0007787 (UMLS CUI [1])
Diabetes Mellitus | Oral hypoglycemic | Insulin
Item
4. diabetes and currently taking an oral hypoglycemic agent or insulin
boolean
C0011849 (UMLS CUI [1])
C0359086 (UMLS CUI [2])
C0021641 (UMLS CUI [3])
Age
Item
5. age = or > than 70 years
boolean
C0001779 (UMLS CUI [1])
Hypertensive disease
Item
6. hypertension
boolean
C0020538 (UMLS CUI [1])
Creatinine measurement, serum
Item
7. serum creatinine > 175 µmol/l
boolean
C0201976 (UMLS CUI [1])
Tobacco use
Item
8. history of smoking within 2 years of surgery, or
boolean
C0543414 (UMLS CUI [1])
Emergency surgery
Item
9. undergoing emergent/urgent surgery
boolean
C4264510 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Aspirin
Item
patients has taken asa < or = to 72 hours before scheduled surgery
boolean
C0004057 (UMLS CUI [1])
Aspirin allergy | Clonidine allergy
Item
history of asa or clonidine hypersensitivity or allergy
boolean
C0004058 (UMLS CUI [1])
C0570975 (UMLS CUI [2])
Systolic Pressure
Item
systolic blood pressure < 105 mm hg
boolean
C0871470 (UMLS CUI [1])
Heart rate
Item
heart rate < 55 beats per minute
boolean
C0018810 (UMLS CUI [1])
Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent
Item
second or third degree heart block without a pacemaker
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0030163 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Peptic Ulcer
Item
patient has active peptic ulcer disease
boolean
C0030920 (UMLS CUI [1])
Bare metal stent
Item
patient has had a bare metal stent in the six weeks prior to randomization
boolean
C2825200 (UMLS CUI [1])
Drug-Eluting Stents
Item
patient has had a drug eluting stent in the year prior to randomization
boolean
C1322815 (UMLS CUI [1])
Alpha 2 agonist | alpha-methyldopa | Reserpine | clopidogrel | Ticlopidine
Item
patient is currently taking an alpha-2 agonist, alpha methyldopa, reserpine, clopidogrel, or ticlopidine
boolean
C1268904 (UMLS CUI [1])
C0025741 (UMLS CUI [2])
C0035179 (UMLS CUI [3])
C0070166 (UMLS CUI [4])
C0040207 (UMLS CUI [5])
Intracranial surgery | Carotid Endarterectomy | Operation on retina
Item
patient undergoing intracranial surgery, carotid endarterectomy, or retinal surgery
boolean
C0745377 (UMLS CUI [1])
C0014099 (UMLS CUI [2])
C0197770 (UMLS CUI [3])
Study Subject Participation Status Surgeon Unwilling | Clonidine Trial perioperative | Aspirin Trial perioperative
Item
surgeon unwilling to have patient participate in a participate in a perioperative clonidine/asa trial
boolean
C2348568 (UMLS CUI [1,1])
C0582175 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0009014 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C1518988 (UMLS CUI [2,3])
C0004057 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
C1518988 (UMLS CUI [3,3])
Enrollment Clinical Trial Specified
Item
prior enrolment in the poise-2 pilot trial
boolean
C1516879 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Informed Consent Unable | Informed Consent Refused
Item
unable to obtain or refusal to consent prior to surgery
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
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