ID

28737

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01405690

Stichworte

Versionen (1)
  1. 30.01.18 30.01.18 -
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See clinicaltrials.gov

Hochgeladen am

30. Januar 2018

DOI

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Eligibility Coronary Artery Disease NCT01405690

Englisch

Eligibility Coronary Artery Disease NCT01405690

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

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

Informed Consent

Datentyp

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
Beschreibung

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

Datentyp

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:
Beschreibung

Predictor Clinical Quantity | Revised cardiac risk index

Datentyp

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)
Beschreibung

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

Datentyp

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)
Beschreibung

Diabetes Mellitus Requirement Insulin

Datentyp

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)
Beschreibung

Congestive heart failure New York Heart Association Classification

Datentyp

boolean

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

Cerebrovascular Disorders

Datentyp

boolean

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

Carotid Stenosis

Datentyp

boolean

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

Cerebrovascular Disorder Ischemic | Cerebrovascular accident | Transient Ischemic Attack

Datentyp

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
Beschreibung

Aortic Disease Vascular | Peripheral Vascular Diseases

Datentyp

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
Beschreibung

Risk of Coronary Artery Disease

Datentyp

boolean

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

Age

Datentyp

boolean

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

Hypertensive disease Medicated

Datentyp

boolean

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

Cholesterol

Datentyp

boolean

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

Diabetes Mellitus | Oral hypoglycemic

Datentyp

boolean

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

Family history of coronary artery disease

Datentyp

boolean

Alias
UMLS CUI [1]
C2317524
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Informed Consent Lacking

Datentyp

boolean

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

Pregnancy

Datentyp

boolean

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

Allergic reaction to iodinated contrast material

Datentyp

boolean

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

BETA BLOCKER ALLERGY | Medical contraindication Adrenergic beta-Antagonists

Datentyp

boolean

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

Estimated Glomerular Filtration Rate

Datentyp

boolean

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

Hemodynamic instability | Hemodynamics Impaired

Datentyp

boolean

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

Urgent surgical procedure

Datentyp

boolean

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

Atrial Fibrillation beats per minute

Datentyp

boolean

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

Tachyarrhythmia Uncontrolled

Datentyp

boolean

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

Second degree atrioventricular block | Complete atrioventricular block

Datentyp

boolean

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

Aortic Stenosis Moderate | Aortic stenosis, severe

Datentyp

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
Beschreibung

Breath Holding Duration Unable

Datentyp

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
Beschreibung

Multiple Myeloma | Organ Transplantation

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Congestive heart failure New York Heart Association Classification

Datentyp

boolean

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

Anemia, severe

Datentyp

boolean

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

Intracranial Hypertension

Datentyp

boolean

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

Angle Closure Glaucoma

Datentyp

boolean

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

Medical contraindication Absolute Nitroglycerin

Datentyp

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
Beschreibung

Medical condition Problem | Medical History Problem

Datentyp

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) -
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT01405690

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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