ID

28737

Description

The Role Of Noninvasive 320-Row Multidetector Computer Tomography; ODM derived from: https://clinicaltrials.gov/show/NCT01405690

Lien

https://clinicaltrials.gov/show/NCT01405690

Mots-clés

  1. 30/01/2018 30/01/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

30 janvier 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Coronary Artery Disease NCT01405690

Eligibility Coronary Artery Disease NCT01405690

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, 18 years and older
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
able to understand and willing to sign the informed consent form
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
undergoing vascular surgery or intermediate risk surgery (these include intraperitoneal, intrathoracic, carotid endarterectomy , head and neck, orthopedics or prostate) and
Description

Vascular Surgical Procedures | Operative Surgical Procedures Intermediate Risk | Operative Surgical Procedures Intraperitoneal | Thoracic Surgical Procedures | Carotid Endarterectomy | Head and neck surgery | Orthopedic Surgical Procedures | Operation on prostate

Type de données

boolean

Alias
UMLS CUI [1]
C0042381
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C3640764
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0442120
UMLS CUI [4]
C0524832
UMLS CUI [5]
C0014099
UMLS CUI [6]
C1512343
UMLS CUI [7]
C1136201
UMLS CUI [8]
C0194790
one or more of the following clinical predictors according to the revised cardiac risk index:
Description

Predictor Clinical Quantity | Revised cardiac risk index

Type de données

boolean

Alias
UMLS CUI [1,1]
C2698872
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C3164217
1. history of ischemic heart disease (cabg, mi, stent, positive stress test, q-waves on ecg)
Description

Myocardial Ischemia | Coronary Artery Bypass Surgery | Myocardial Infarction | Stent | Stress Test Positive | ECG Q Waves

Type de données

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2]
C0010055
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0038257
UMLS CUI [5,1]
C3494508
UMLS CUI [5,2]
C1514241
UMLS CUI [6]
C1709789
2. diabetes (requiring insulin)
Description

Diabetes Mellitus Requirement Insulin

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021641
3. history of congestive heart failure (nyha i- ii)
Description

Congestive heart failure New York Heart Association Classification

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
4. history of cerebrovascular disease, any of :
Description

Cerebrovascular Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0007820
1. history of carotid stenosis
Description

Carotid Stenosis

Type de données

boolean

Alias
UMLS CUI [1]
C0007282
2. history of ischemic cerebrovascular disease (stroke or tia)
Description

Cerebrovascular Disorder Ischemic | Cerebrovascular accident | Transient Ischemic Attack

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007820
UMLS CUI [1,2]
C0475224
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
5. aortic or peripheral vascular disease or
Description

Aortic Disease Vascular | Peripheral Vascular Diseases

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003493
UMLS CUI [1,2]
C1801960
UMLS CUI [2]
C0085096
6. risk of cad with 3 or more of the following
Description

Risk of Coronary Artery Disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C1956346
1. age ≥ 70 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
2. hypertension (medicated)
Description

Hypertensive disease Medicated

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C3812868
3. cholesterol (medicated)
Description

Cholesterol

Type de données

boolean

Alias
UMLS CUI [1]
C0008377
4. diabetes (medicated-oral hypoglycemic)
Description

Diabetes Mellitus | Oral hypoglycemic

Type de données

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0359086
5. family history of coronary artery disease
Description

Family history of coronary artery disease

Type de données

boolean

Alias
UMLS CUI [1]
C2317524
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. lack of consent for participation
Description

Informed Consent Lacking

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
2. pregnancy
Description

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
3. history of an allergic response to iodinated contrast medium
Description

Allergic reaction to iodinated contrast material

Type de données

boolean

Alias
UMLS CUI [1]
C2215738
4. history of an allergic response, or other contraindication to beta blockers
Description

BETA BLOCKER ALLERGY | Medical contraindication Adrenergic beta-Antagonists

Type de données

boolean

Alias
UMLS CUI [1]
C0741466
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0001645
5. egfr < 45 ml/min
Description

Estimated Glomerular Filtration Rate

Type de données

boolean

Alias
UMLS CUI [1]
C3811844
6. hemodynamically unstable/compromised
Description

Hemodynamic instability | Hemodynamics Impaired

Type de données

boolean

Alias
UMLS CUI [1]
C0948268
UMLS CUI [2,1]
C0019010
UMLS CUI [2,2]
C0221099
7. urgent surgery
Description

Urgent surgical procedure

Type de données

boolean

Alias
UMLS CUI [1]
C2188405
8. atrial fibrillation > 80 bpm
Description

Atrial Fibrillation beats per minute

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0439385
9. uncontrolled tachyarrhythmia
Description

Tachyarrhythmia Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0080203
UMLS CUI [1,2]
C0205318
10. atrioventricular block (second and third degree)
Description

Second degree atrioventricular block | Complete atrioventricular block

Type de données

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
11. moderate to severe aortic stenosis
Description

Aortic Stenosis Moderate | Aortic stenosis, severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003507
UMLS CUI [1,2]
C0205081
UMLS CUI [2]
C3806272
12. not able to hold breath for 5 - 10 seconds
Description

Breath Holding Duration Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0235744
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C1299582
13. history of multiple myeloma or organ transplant
Description

Multiple Myeloma | Organ Transplantation

Type de données

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0029216
14. severe pulmonary disease including copd, pah, asthma
Description

Lung disease Severe | Severe chronic obstructive pulmonary disease | Pulmonary arterial hypertension Severe | Severe asthma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0730607
UMLS CUI [3,1]
C2973725
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0581126
15. congestive heart failure presented as nyha functional class iii - iv
Description

Congestive heart failure New York Heart Association Classification

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
16. severe anemia
Description

Anemia, severe

Type de données

boolean

Alias
UMLS CUI [1]
C0238644
17. increased intracranial pressure
Description

Intracranial Hypertension

Type de données

boolean

Alias
UMLS CUI [1]
C0151740
18. closed angle glaucoma
Description

Angle Closure Glaucoma

Type de données

boolean

Alias
UMLS CUI [1]
C0017605
19. absolute contraindication to nitroglycerin
Description

Medical contraindication Absolute Nitroglycerin

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0205344
UMLS CUI [1,3]
C0017887
20. presence of medical condition or history that investigator feels would be problematic
Description

Medical condition Problem | Medical History Problem

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0033213
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0033213
21. acute myocardial infarction (within 4-6 weeks) -
Description

Myocardial Infarction

Type de données

boolean

Alias
UMLS CUI [1]
C0027051

Similar models

Eligibility Coronary Artery Disease NCT01405690

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female, 18 years and older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
able to understand and willing to sign the informed consent form
boolean
C0021430 (UMLS CUI [1])
Vascular Surgical Procedures | Operative Surgical Procedures Intermediate Risk | Operative Surgical Procedures Intraperitoneal | Thoracic Surgical Procedures | Carotid Endarterectomy | Head and neck surgery | Orthopedic Surgical Procedures | Operation on prostate
Item
undergoing vascular surgery or intermediate risk surgery (these include intraperitoneal, intrathoracic, carotid endarterectomy , head and neck, orthopedics or prostate) and
boolean
C0042381 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C3640764 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C0442120 (UMLS CUI [3,2])
C0524832 (UMLS CUI [4])
C0014099 (UMLS CUI [5])
C1512343 (UMLS CUI [6])
C1136201 (UMLS CUI [7])
C0194790 (UMLS CUI [8])
Predictor Clinical Quantity | Revised cardiac risk index
Item
one or more of the following clinical predictors according to the revised cardiac risk index:
boolean
C2698872 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3164217 (UMLS CUI [2])
Myocardial Ischemia | Coronary Artery Bypass Surgery | Myocardial Infarction | Stent | Stress Test Positive | ECG Q Waves
Item
1. history of ischemic heart disease (cabg, mi, stent, positive stress test, q-waves on ecg)
boolean
C0151744 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0038257 (UMLS CUI [4])
C3494508 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
C1709789 (UMLS CUI [6])
Diabetes Mellitus Requirement Insulin
Item
2. diabetes (requiring insulin)
boolean
C0011849 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021641 (UMLS CUI [1,3])
Congestive heart failure New York Heart Association Classification
Item
3. history of congestive heart failure (nyha i- ii)
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cerebrovascular Disorders
Item
4. history of cerebrovascular disease, any of :
boolean
C0007820 (UMLS CUI [1])
Carotid Stenosis
Item
1. history of carotid stenosis
boolean
C0007282 (UMLS CUI [1])
Cerebrovascular Disorder Ischemic | Cerebrovascular accident | Transient Ischemic Attack
Item
2. history of ischemic cerebrovascular disease (stroke or tia)
boolean
C0007820 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Aortic Disease Vascular | Peripheral Vascular Diseases
Item
5. aortic or peripheral vascular disease or
boolean
C0003493 (UMLS CUI [1,1])
C1801960 (UMLS CUI [1,2])
C0085096 (UMLS CUI [2])
Risk of Coronary Artery Disease
Item
6. risk of cad with 3 or more of the following
boolean
C0035647 (UMLS CUI [1,1])
C1956346 (UMLS CUI [1,2])
Age
Item
1. age ≥ 70 years
boolean
C0001779 (UMLS CUI [1])
Hypertensive disease Medicated
Item
2. hypertension (medicated)
boolean
C0020538 (UMLS CUI [1,1])
C3812868 (UMLS CUI [1,2])
Cholesterol
Item
3. cholesterol (medicated)
boolean
C0008377 (UMLS CUI [1])
Diabetes Mellitus | Oral hypoglycemic
Item
4. diabetes (medicated-oral hypoglycemic)
boolean
C0011849 (UMLS CUI [1])
C0359086 (UMLS CUI [2])
Family history of coronary artery disease
Item
5. family history of coronary artery disease
boolean
C2317524 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Informed Consent Lacking
Item
1. lack of consent for participation
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Pregnancy
Item
2. pregnancy
boolean
C0032961 (UMLS CUI [1])
Allergic reaction to iodinated contrast material
Item
3. history of an allergic response to iodinated contrast medium
boolean
C2215738 (UMLS CUI [1])
BETA BLOCKER ALLERGY | Medical contraindication Adrenergic beta-Antagonists
Item
4. history of an allergic response, or other contraindication to beta blockers
boolean
C0741466 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0001645 (UMLS CUI [2,2])
Estimated Glomerular Filtration Rate
Item
5. egfr < 45 ml/min
boolean
C3811844 (UMLS CUI [1])
Hemodynamic instability | Hemodynamics Impaired
Item
6. hemodynamically unstable/compromised
boolean
C0948268 (UMLS CUI [1])
C0019010 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
Urgent surgical procedure
Item
7. urgent surgery
boolean
C2188405 (UMLS CUI [1])
Atrial Fibrillation beats per minute
Item
8. atrial fibrillation > 80 bpm
boolean
C0004238 (UMLS CUI [1,1])
C0439385 (UMLS CUI [1,2])
Tachyarrhythmia Uncontrolled
Item
9. uncontrolled tachyarrhythmia
boolean
C0080203 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Second degree atrioventricular block | Complete atrioventricular block
Item
10. atrioventricular block (second and third degree)
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
Aortic Stenosis Moderate | Aortic stenosis, severe
Item
11. moderate to severe aortic stenosis
boolean
C0003507 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C3806272 (UMLS CUI [2])
Breath Holding Duration Unable
Item
12. not able to hold breath for 5 - 10 seconds
boolean
C0235744 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Multiple Myeloma | Organ Transplantation
Item
13. history of multiple myeloma or organ transplant
boolean
C0026764 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
Lung disease Severe | Severe chronic obstructive pulmonary disease | Pulmonary arterial hypertension Severe | Severe asthma
Item
14. severe pulmonary disease including copd, pah, asthma
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0730607 (UMLS CUI [2])
C2973725 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0581126 (UMLS CUI [4])
Congestive heart failure New York Heart Association Classification
Item
15. congestive heart failure presented as nyha functional class iii - iv
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Anemia, severe
Item
16. severe anemia
boolean
C0238644 (UMLS CUI [1])
Intracranial Hypertension
Item
17. increased intracranial pressure
boolean
C0151740 (UMLS CUI [1])
Angle Closure Glaucoma
Item
18. closed angle glaucoma
boolean
C0017605 (UMLS CUI [1])
Medical contraindication Absolute Nitroglycerin
Item
19. absolute contraindication to nitroglycerin
boolean
C1301624 (UMLS CUI [1,1])
C0205344 (UMLS CUI [1,2])
C0017887 (UMLS CUI [1,3])
Medical condition Problem | Medical History Problem
Item
20. presence of medical condition or history that investigator feels would be problematic
boolean
C3843040 (UMLS CUI [1,1])
C0033213 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0033213 (UMLS CUI [2,2])
Myocardial Infarction
Item
21. acute myocardial infarction (within 4-6 weeks) -
boolean
C0027051 (UMLS CUI [1])

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