Eligibility Cardiovascular Disease NCT01082874

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StudyEvent: Eligibility
1. Eligibility Cardiovascular Disease NCT01082874

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

Exclusion Criteria

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])

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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Eligibility Cardiovascular Disease NCT01082874