ID

36359

Description

Vortioxetine in Patients With Major Depressive Disorder and Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02454426

Link

https://clinicaltrials.gov/show/NCT02454426

Keywords

Versions (1)
  1. 5/7/19 5/7/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 7, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02454426

English

Eligibility Major Depressive Disorder NCT02454426

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. dsm-5 diagnosis of a major depressive disorder based on clinical evaluation by the study psychiatrist
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
2. at least moderate severity of depression as indicated by a montgomery-asberg depression rating scale (madrs) score of 22 or greater
Description

Moderate depression Montgomery-Asberg Depression Rating Scale Questionnaire | Severe depression Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1,1]
C0588007
UMLS CUI [1,2]
C4054475
UMLS CUI [2,1]
C0588008
UMLS CUI [2,2]
C4054475
3. history of coronary artery disease as defined by:
Description

Coronary Artery Disease

Data type

boolean

Alias
UMLS CUI [1]
C1956346
history of coronary stenosis in one or more vessels that is greater ≥ 70% by coronary angiography or ct angiogram, or
Description

Coronary Stenosis Percentage Vessel Quantity | Coronary angiography | CT Angiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0242231
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0005847
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0085532
UMLS CUI [3]
C1536105
history of abnormal stress test (at least medium-sized, moderate, reversible defect), or
Description

Cardiac stress test abnormal | Defect Moderate | Defect Reversible

Data type

boolean

Alias
UMLS CUI [1]
C1096350
UMLS CUI [2,1]
C1457869
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C1457869
UMLS CUI [3,2]
C0205343
history of documented myocardial infarction including st elevation myocardial infarction or non-st elevation myocardial infarction (with elevated troponins), or
Description

Myocardial Infarction | ST segment elevation myocardial infarction | Non-ST elevation (NSTEMI) myocardial infarction | Troponin increased

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C1536220
UMLS CUI [3]
C1561921
UMLS CUI [4]
C1141948
4. evidence of adequate treatment of the coronary artery disease as defined by at least one of the following that was done at least six months prior to the screening visit, and was followed by the patient being clinically stable in the opinion of a cardiologist who has evaluated the case:
Description

Therapeutic procedure Adequate Coronary Artery Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205411
UMLS CUI [1,3]
C1956346
coronary artery bypass grafting (cabg)
Description

Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0010055
percutaneous coronary intervention (pci)/ stenting
Description

Percutaneous Coronary Intervention | Stenting

Data type

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2]
C2348535
adequate management with optimal medical treatment (such as one or more of the following medications: aspirin, beta blockers, a statin (e.g., atorvastatin), and either an ace inhibitor or an angiotensin-receptor blocker.)
Description

Therapeutic procedure Optimal | Aspirin | Adrenergic beta-1 Receptor Antagonists | Statin | atorvastatin | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
UMLS CUI [2]
C0004057
UMLS CUI [3]
C0304516
UMLS CUI [4]
C0360714
UMLS CUI [5]
C0286651
UMLS CUI [6]
C0003015
UMLS CUI [7]
C0521942
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
psychiatric exclusion criteria:
Description

Exclusion Criteria Psychiatric

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205487
1. patients who in the past have failed to respond to a trial of vortioxetine at the minimum recommended dose (10 mg/day) or greater taken for at least six weeks, or had unacceptable adverse effects while taking vortioxetine.
Description

Therapy non-responder | Vortioxetine U/day | Adverse effects Unacceptable Vortioxetine

Data type

boolean

Alias
UMLS CUI [1]
C0919875
UMLS CUI [2,1]
C3661282
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0879626
UMLS CUI [3,2]
C1883420
UMLS CUI [3,3]
C3661282
2. patients must not have failed treatment with more than one antidepressant (taken at an adequate dose and for at least six weeks) in the current episode of major depressive disorder (i.e., did not have > 50% reduction in severity of depression based on patient history)
Description

Antidepressive Agents Quantity Major depressive episode

Data type

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0024517
3. patients with a current primary dsm-5 diagnosis of:
Description

Principal diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0332137
i) delirium, dementia, amnestic, or other cognitive disorder; ii) eating disorder (including anorexia nervosa or bulimia); iii) obsessive compulsive disorder; iv) panic disorder; v) post-traumatic stress disorder (ptsd);
Description

Delirium | Dementia | Amnestic Disorder | Cognition Disorders | Eating Disorders | Anorexia Nervosa | Bulimia | Obsessive-Compulsive Disorder | Panic Disorder | Post-Traumatic Stress Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0011206
UMLS CUI [2]
C0497327
UMLS CUI [3]
C0002625
UMLS CUI [4]
C0009241
UMLS CUI [5]
C0013473
UMLS CUI [6]
C0003125
UMLS CUI [7]
C0006370
UMLS CUI [8]
C0028768
UMLS CUI [9]
C0030319
UMLS CUI [10]
C0038436
4. current or past (lifetime) dsm-5 diagnosis of:
Description

Diagnosis | Diagnosis Lifetime

Data type

boolean

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C4071830
i) bipolar i or ii disorder; ii) hypomanic episode iii) substance-induced manic or hypomanic episode iii) schizophrenia or other psychotic disorder
Description

Bipolar I disorder | Bipolar II disorder | Hypomanic episode | Manic episode Drug-induced | Hypomanic episode Drug-induced | Schizophrenia | Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0853193
UMLS CUI [2]
C0236788
UMLS CUI [3]
C1396834
UMLS CUI [4,1]
C0349208
UMLS CUI [4,2]
C0458082
UMLS CUI [5,1]
C1396834
UMLS CUI [5,2]
C0458082
UMLS CUI [6]
C0036341
UMLS CUI [7]
C0033975
cardiovascular exclusion criteria:
Description

Exclusion Criteria Cardiovascular

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C3887460
1. patients who have had a myocardial infarction within 30 days of the screening visit
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
2. any cardiovascular condition that is unstable or decompensated
Description

Cardiovascular Disease Unstable | Cardiovascular Disease Decompensated

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205434
3. in the opinion of the investigators, the patient is at significant risk of cardiovascular adverse events
Description

At risk Adverse event Cardiovascular

Data type

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C3887460
4. coronary artery bypass grafting (cabg) or percutaneous coronary intervention (pci)/
Description

Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2]
C1532338
stenting within three months of the screening visit
Description

Stenting

Data type

boolean

Alias
UMLS CUI [1]
C2348535
5. admission to a hospital for any cardiac condition within three months of the screening visit
Description

Hospital admission Due to Heart Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0018799
6. decompensated heart failure within 6 months of the screening visit
Description

Decompensated cardiac failure

Data type

boolean

Alias
UMLS CUI [1]
C0581377
7. qtc prolongation (screening ecg with qtc ≥ 450 msec for men or qtc ≥ 470 msec for women) using qtc fridericia correction
Description

Prolonged QTc interval Fridericia formula | Gender

Data type

boolean

Alias
UMLS CUI [1,1]
C1560305
UMLS CUI [1,2]
C4037934
UMLS CUI [2]
C0079399
8. second-degree (if mobitz ii) or third-degree atrioventricular block
Description

Second degree atrioventricular block | Mobitz type II atrioventricular block | Complete atrioventricular block

Data type

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0155700
UMLS CUI [3]
C0151517
9. heart rate on ecg of ≤ 50 bpm or ≥ 120 bpm or any heart rate that is clinically symptomatic
Description

Heart rate Electrocardiography | Heart rate Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C1623258
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0231220
10. premature ventricular contractions (pvcs) associated with clinical symptoms and/or any complex premature ventricular contractions (ie, pvcs that are frequent [> 30/hr] or ≥ 2 beats if multifocal, or show bigeminy, trigeminy, quadrigeminy, couplets, triplets [salvos], or the r on t phenomenon)
Description

Premature ventricular contractions Associated with Symptoms Clinical | Premature ventricular contractions Complex | Premature ventricular contractions Frequent | Premature ventricular contractions Multifocal | Premature ventricular contractions Bigeminy | Premature ventricular contractions Trigeminy | Premature ventricular contractions Quadrigeminy | Premature ventricular contractions Couplets | Premature ventricular contractions, including couplets and triplets | Other Coding | R on T phenomenon

Data type

boolean

Alias
UMLS CUI [1,1]
C0151636
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205210
UMLS CUI [2,1]
C0151636
UMLS CUI [2,2]
C0439855
UMLS CUI [3,1]
C0151636
UMLS CUI [3,2]
C0332183
UMLS CUI [4,1]
C0151636
UMLS CUI [4,2]
C0205292
UMLS CUI [5,1]
C0151636
UMLS CUI [5,2]
C3714585
UMLS CUI [6,1]
C0151636
UMLS CUI [6,2]
C0232119
UMLS CUI [7,1]
C0151636
UMLS CUI [7,2]
C0429000
UMLS CUI [8,1]
C0151636
UMLS CUI [8,2]
C0429001
UMLS CUI [9]
C3554050
UMLS CUI [10]
C3846158
UMLS CUI [11]
C0877658
11. atrial fibrillation or flutter
Description

Atrial Fibrillation | Atrial Flutter

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0004239
12. supine (after patient has been supine for 5 minutes) systolic bp > 160 mm hg or < 90 mm hg or diastolic bp > 100 mm hg or any systolic or diastolic bp that is symptomatic or clinically significant based on the opinion of the principal investigator
Description

Lying systolic blood pressure | Lying diastolic blood pressure | Systolic Pressure Symptomatic | Diastolic blood pressure Symptomatic

Data type

boolean

Alias
UMLS CUI [1]
C1319895
UMLS CUI [2]
C1319896
UMLS CUI [3,1]
C0871470
UMLS CUI [3,2]
C0231220
UMLS CUI [4,1]
C0428883
UMLS CUI [4,2]
C0231220
13. patients who are receiving warfarin
Description

Warfarin

Data type

boolean

Alias
UMLS CUI [1]
C0043031
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Similar models

Eligibility Major Depressive Disorder NCT02454426

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
1. dsm-5 diagnosis of a major depressive disorder based on clinical evaluation by the study psychiatrist
boolean
C1269683 (UMLS CUI [1])
Moderate depression Montgomery-Asberg Depression Rating Scale Questionnaire | Severe depression Montgomery-Asberg Depression Rating Scale Questionnaire
Item
2. at least moderate severity of depression as indicated by a montgomery-asberg depression rating scale (madrs) score of 22 or greater
boolean
C0588007 (UMLS CUI [1,1])
C4054475 (UMLS CUI [1,2])
C0588008 (UMLS CUI [2,1])
C4054475 (UMLS CUI [2,2])
Coronary Artery Disease
Item
3. history of coronary artery disease as defined by:
boolean
C1956346 (UMLS CUI [1])
Coronary Stenosis Percentage Vessel Quantity | Coronary angiography | CT Angiography
Item
history of coronary stenosis in one or more vessels that is greater ≥ 70% by coronary angiography or ct angiogram, or
boolean
C0242231 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0085532 (UMLS CUI [2])
C1536105 (UMLS CUI [3])
Cardiac stress test abnormal | Defect Moderate | Defect Reversible
Item
history of abnormal stress test (at least medium-sized, moderate, reversible defect), or
boolean
C1096350 (UMLS CUI [1])
C1457869 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C1457869 (UMLS CUI [3,1])
C0205343 (UMLS CUI [3,2])
Myocardial Infarction | ST segment elevation myocardial infarction | Non-ST elevation (NSTEMI) myocardial infarction | Troponin increased
Item
history of documented myocardial infarction including st elevation myocardial infarction or non-st elevation myocardial infarction (with elevated troponins), or
boolean
C0027051 (UMLS CUI [1])
C1536220 (UMLS CUI [2])
C1561921 (UMLS CUI [3])
C1141948 (UMLS CUI [4])
Therapeutic procedure Adequate Coronary Artery Disease
Item
4. evidence of adequate treatment of the coronary artery disease as defined by at least one of the following that was done at least six months prior to the screening visit, and was followed by the patient being clinically stable in the opinion of a cardiologist who has evaluated the case:
boolean
C0087111 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C1956346 (UMLS CUI [1,3])
Coronary Artery Bypass Surgery
Item
coronary artery bypass grafting (cabg)
boolean
C0010055 (UMLS CUI [1])
Percutaneous Coronary Intervention | Stenting
Item
percutaneous coronary intervention (pci)/ stenting
boolean
C1532338 (UMLS CUI [1])
C2348535 (UMLS CUI [2])
Therapeutic procedure Optimal | Aspirin | Adrenergic beta-1 Receptor Antagonists | Statin | atorvastatin | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
adequate management with optimal medical treatment (such as one or more of the following medications: aspirin, beta blockers, a statin (e.g., atorvastatin), and either an ace inhibitor or an angiotensin-receptor blocker.)
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0004057 (UMLS CUI [2])
C0304516 (UMLS CUI [3])
C0360714 (UMLS CUI [4])
C0286651 (UMLS CUI [5])
C0003015 (UMLS CUI [6])
C0521942 (UMLS CUI [7])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Exclusion Criteria Psychiatric
Item
psychiatric exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205487 (UMLS CUI [1,2])
Therapy non-responder | Vortioxetine U/day | Adverse effects Unacceptable Vortioxetine
Item
1. patients who in the past have failed to respond to a trial of vortioxetine at the minimum recommended dose (10 mg/day) or greater taken for at least six weeks, or had unacceptable adverse effects while taking vortioxetine.
boolean
C0919875 (UMLS CUI [1])
C3661282 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0879626 (UMLS CUI [3,1])
C1883420 (UMLS CUI [3,2])
C3661282 (UMLS CUI [3,3])
Antidepressive Agents Quantity Major depressive episode
Item
2. patients must not have failed treatment with more than one antidepressant (taken at an adequate dose and for at least six weeks) in the current episode of major depressive disorder (i.e., did not have > 50% reduction in severity of depression based on patient history)
boolean
C0003289 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0024517 (UMLS CUI [1,3])
Principal diagnosis
Item
3. patients with a current primary dsm-5 diagnosis of:
boolean
C0332137 (UMLS CUI [1])
Delirium | Dementia | Amnestic Disorder | Cognition Disorders | Eating Disorders | Anorexia Nervosa | Bulimia | Obsessive-Compulsive Disorder | Panic Disorder | Post-Traumatic Stress Disorder
Item
i) delirium, dementia, amnestic, or other cognitive disorder; ii) eating disorder (including anorexia nervosa or bulimia); iii) obsessive compulsive disorder; iv) panic disorder; v) post-traumatic stress disorder (ptsd);
boolean
C0011206 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0002625 (UMLS CUI [3])
C0009241 (UMLS CUI [4])
C0013473 (UMLS CUI [5])
C0003125 (UMLS CUI [6])
C0006370 (UMLS CUI [7])
C0028768 (UMLS CUI [8])
C0030319 (UMLS CUI [9])
C0038436 (UMLS CUI [10])
Diagnosis | Diagnosis Lifetime
Item
4. current or past (lifetime) dsm-5 diagnosis of:
boolean
C0011900 (UMLS CUI [1])
C0011900 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
Bipolar I disorder | Bipolar II disorder | Hypomanic episode | Manic episode Drug-induced | Hypomanic episode Drug-induced | Schizophrenia | Psychotic Disorders
Item
i) bipolar i or ii disorder; ii) hypomanic episode iii) substance-induced manic or hypomanic episode iii) schizophrenia or other psychotic disorder
boolean
C0853193 (UMLS CUI [1])
C0236788 (UMLS CUI [2])
C1396834 (UMLS CUI [3])
C0349208 (UMLS CUI [4,1])
C0458082 (UMLS CUI [4,2])
C1396834 (UMLS CUI [5,1])
C0458082 (UMLS CUI [5,2])
C0036341 (UMLS CUI [6])
C0033975 (UMLS CUI [7])
Exclusion Criteria Cardiovascular
Item
cardiovascular exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
Myocardial Infarction
Item
1. patients who have had a myocardial infarction within 30 days of the screening visit
boolean
C0027051 (UMLS CUI [1])
Cardiovascular Disease Unstable | Cardiovascular Disease Decompensated
Item
2. any cardiovascular condition that is unstable or decompensated
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205434 (UMLS CUI [2,2])
At risk Adverse event Cardiovascular
Item
3. in the opinion of the investigators, the patient is at significant risk of cardiovascular adverse events
boolean
C1444641 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3887460 (UMLS CUI [1,3])
Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
4. coronary artery bypass grafting (cabg) or percutaneous coronary intervention (pci)/
boolean
C0010055 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
Stenting
Item
stenting within three months of the screening visit
boolean
C2348535 (UMLS CUI [1])
Hospital admission Due to Heart Disease
Item
5. admission to a hospital for any cardiac condition within three months of the screening visit
boolean
C0184666 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0018799 (UMLS CUI [1,3])
Decompensated cardiac failure
Item
6. decompensated heart failure within 6 months of the screening visit
boolean
C0581377 (UMLS CUI [1])
Prolonged QTc interval Fridericia formula | Gender
Item
7. qtc prolongation (screening ecg with qtc ≥ 450 msec for men or qtc ≥ 470 msec for women) using qtc fridericia correction
boolean
C1560305 (UMLS CUI [1,1])
C4037934 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
Second degree atrioventricular block | Mobitz type II atrioventricular block | Complete atrioventricular block
Item
8. second-degree (if mobitz ii) or third-degree atrioventricular block
boolean
C0264906 (UMLS CUI [1])
C0155700 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
Heart rate Electrocardiography | Heart rate Symptomatic
Item
9. heart rate on ecg of ≤ 50 bpm or ≥ 120 bpm or any heart rate that is clinically symptomatic
boolean
C0018810 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
C0018810 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Premature ventricular contractions Associated with Symptoms Clinical | Premature ventricular contractions Complex | Premature ventricular contractions Frequent | Premature ventricular contractions Multifocal | Premature ventricular contractions Bigeminy | Premature ventricular contractions Trigeminy | Premature ventricular contractions Quadrigeminy | Premature ventricular contractions Couplets | Premature ventricular contractions, including couplets and triplets | Other Coding | R on T phenomenon
Item
10. premature ventricular contractions (pvcs) associated with clinical symptoms and/or any complex premature ventricular contractions (ie, pvcs that are frequent [> 30/hr] or ≥ 2 beats if multifocal, or show bigeminy, trigeminy, quadrigeminy, couplets, triplets [salvos], or the r on t phenomenon)
boolean
C0151636 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205210 (UMLS CUI [1,4])
C0151636 (UMLS CUI [2,1])
C0439855 (UMLS CUI [2,2])
C0151636 (UMLS CUI [3,1])
C0332183 (UMLS CUI [3,2])
C0151636 (UMLS CUI [4,1])
C0205292 (UMLS CUI [4,2])
C0151636 (UMLS CUI [5,1])
C3714585 (UMLS CUI [5,2])
C0151636 (UMLS CUI [6,1])
C0232119 (UMLS CUI [6,2])
C0151636 (UMLS CUI [7,1])
C0429000 (UMLS CUI [7,2])
C0151636 (UMLS CUI [8,1])
C0429001 (UMLS CUI [8,2])
C3554050 (UMLS CUI [9])
C3846158 (UMLS CUI [10])
C0877658 (UMLS CUI [11])
Atrial Fibrillation | Atrial Flutter
Item
11. atrial fibrillation or flutter
boolean
C0004238 (UMLS CUI [1])
C0004239 (UMLS CUI [2])
Lying systolic blood pressure | Lying diastolic blood pressure | Systolic Pressure Symptomatic | Diastolic blood pressure Symptomatic
Item
12. supine (after patient has been supine for 5 minutes) systolic bp > 160 mm hg or < 90 mm hg or diastolic bp > 100 mm hg or any systolic or diastolic bp that is symptomatic or clinically significant based on the opinion of the principal investigator
boolean
C1319895 (UMLS CUI [1])
C1319896 (UMLS CUI [2])
C0871470 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0428883 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
Warfarin
Item
13. patients who are receiving warfarin
boolean
C0043031 (UMLS CUI [1])
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