ID

16904

Beskrivning

The Arterial Revascularization Therapies Study Part II.; ODM derived from: https://clinicaltrials.gov/show/NCT00235170

Länk

https://clinicaltrials.gov/show/NCT00235170

Nyckelord

Versioner (2)
  1. 2016-08-13 2016-08-13 -
  2. 2016-08-13 2016-08-13 -
Uppladdad den

13 augusti 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00235170

Engelsk

Eligibility Coronary Artery Disease NCT00235170

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with stable (canadian cardiovascular society 1, 2, 3 or 4) or unstable (braunwald class ib, ic, iib, iic, iiib, iiic) angina pectoris and ischemia, or patients with atypical chest pain or even those who are asymptomatic provided they have documented myocardial ischaemia (e.g. treadmill exercise test, radionuclide scintigraphy, stress echocardiography, holter tape);
Beskrivning

Stable angina | Angina, Unstable | Canadian Cardiovascular Society classification of angina | Ischemia | Atypical chest pain | Myocardial Ischemia Asymptomatic | Progressive exercise test on treadmill Test | Radionuclide Imaging | Echocardiography, Stress | 24 Hour ECG

Datatyp

boolean

Alias
UMLS CUI [1]
C0340288
UMLS CUI [2]
C0002965
UMLS CUI [3]
C1277207
UMLS CUI [4]
C0022116
UMLS CUI [5]
C0262384
UMLS CUI [6,1]
C0151744
UMLS CUI [6,2]
C0231221
UMLS CUI [7,1]
C0430507
UMLS CUI [7,2]
C0392366
UMLS CUI [8]
C0034606
UMLS CUI [9]
C0920208
UMLS CUI [10]
C0430461
2. patients who are eligible for coronary revascularization (angioplasty or cabg);
Beskrivning

Patient eligible Coronary revascularisation | Angioplasty | Coronary Artery Bypass Surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0877341
UMLS CUI [2]
C0162577
UMLS CUI [3]
C0010055
3. at least 2 lesions (located in different vessels and in different territories) potentially amenable to stent implantation;
Beskrivning

Lesion Quantity Amenable Placement of stent | Lesion Location Blood Vessels Different | Lesion Location Region Different

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C3900053
UMLS CUI [1,4]
C0522776
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0450429
UMLS CUI [2,3]
C0005847
UMLS CUI [2,4]
C1705242
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0450429
UMLS CUI [3,3]
C0205147
UMLS CUI [3,4]
C1705242
4. de novo native vessels;
Beskrivning

Blood Vessel Native de novo

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005847
UMLS CUI [1,2]
C0302891
UMLS CUI [1,3]
C1515568
5. multivessel disease with at least one significant stenosis in lad and with treatment of the lesion in another major epicardial coronary artery. a two-vessel disease or a three-vessel disease may be viewed as a combination of a side branch and a main epicardial vessel provided they supply different territories; left anterior descending, left circumflex and right coronary artery);
Beskrivning

Disease Blood Vessel Multiple | Left anterior descending coronary artery stenosis Significant | Therapeutic procedure Lesion Coronary artery Epicardial Major | Double coronary vessel disease | Three Vessel Coronary Disease | Anterior descending branch of left coronary artery | Structure of circumflex branch of left coronary artery | Right coronary artery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C0439064
UMLS CUI [2,1]
C3267165
UMLS CUI [2,2]
C0750502
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0221198
UMLS CUI [3,3]
C0205042
UMLS CUI [3,4]
C0442016
UMLS CUI [3,5]
C0205164
UMLS CUI [4]
C0581375
UMLS CUI [5]
C3272265
UMLS CUI [6]
C0226032
UMLS CUI [7]
C0226037
UMLS CUI [8]
C0226042
6. total occluded vessels. one total occluded major epicardial vessel or side branch can be included and targeted as long as one other major vessel has a significant stenosis amenable for sa, provided the age of occlusion is less than one month e.g. recent instability, infarction with ecg changes in the area subtended by the occluded vessel. patients with total occluded vessels of unknown duration or existing longer than one month and a reference over 1.50 mm should not be included, not even as a third or fourth vessel to be dilated;
Beskrivning

vessels; occlusion Total | vessels; occlusion Total Blood Vessel Epicardial Major | Stenosis Significant Blood Vessel Major | Placement of stent | Myocardial Infarction | Electrocardiographic changes

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1386685
UMLS CUI [1,2]
C0439810
UMLS CUI [2,1]
C1386685
UMLS CUI [2,2]
C0439810
UMLS CUI [2,3]
C0005847
UMLS CUI [2,4]
C0442016
UMLS CUI [2,5]
C0205164
UMLS CUI [3,1]
C0678234
UMLS CUI [3,2]
C0750502
UMLS CUI [3,3]
C0005847
UMLS CUI [3,4]
C0205164
UMLS CUI [4]
C0522776
UMLS CUI [5]
C0027051
UMLS CUI [6]
C0855329
7. significant stenosis has been defined as a stenosis of more than 50% in luminal diameter (in at least one view, on visual interpretation or preferably by qca);
Beskrivning

Stenosis Significant Diameter | Quantitative Coronary Angiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678234
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C1301886
UMLS CUI [2]
C4054139
8. left ventricular ejection fraction should be at least 30%.
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. congestive heart failure;
Beskrivning

Congestive heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0018802
2. cabg or percutaneous coronary intervention (pci) procedure;
Beskrivning

Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Datatyp

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2]
C1532338
3. planned need for major surgery (e.g. valve surgery or resection of aortic or left ventricular aneurysm, carotid end-arterectomy, abdominal aortic aneurysm surgery etc.);
Beskrivning

major surgery Planned | Heart Valves Operative Surgical Procedures | Left ventricular aneurysm resection | Aortic Aneurysm Excision | Carotid Endarterectomy | surgery for abdominal aortic aneurysm

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0018826
UMLS CUI [2,2]
C0543467
UMLS CUI [3]
C0397296
UMLS CUI [4,1]
C0003486
UMLS CUI [4,2]
C0728940
UMLS CUI [5]
C0014099
UMLS CUI [6]
C2037604
4. congenital heart disease;
Beskrivning

Congenital heart disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0152021
5. transmural myocardial infarction within the previous seven days and ck has not returned to normal;
Beskrivning

Transmural myocardial infarction | Creatine Kinase Abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C1400513
UMLS CUI [2,1]
C0010287
UMLS CUI [2,2]
C0205161
6. chest pain lasting longer than 30 minutes within 12 hours pre-procedure, if ck enzymes positive (≥ 2x the normal upper limit).
Beskrivning

Chest Pain Duration | Creatine kinase (cardiac enzyme) level

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008031
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C3516327
7. history of any cerebrovascular accident;
Beskrivning

Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
8. left main stenosis of 50% or more;
Beskrivning

Left Main Coronary Artery Stenosis, Percentage

Datatyp

boolean

Alias
UMLS CUI [1]
C2825221
9. intention to treat more than 1 totally occluded major epicardial vessel;
Beskrivning

vessels; occlusion Total Blood Vessel Epicardial Major | Intention Treat Blood Vessel Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1386685
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C0005847
UMLS CUI [1,4]
C0442016
UMLS CUI [1,5]
C0205164
UMLS CUI [2,1]
C1283828
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0005847
UMLS CUI [2,4]
C1265611
10. single vessel (single territory) disease.
Beskrivning

Single coronary vessel disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0581374
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Similar models

Eligibility Coronary Artery Disease NCT00235170

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Stable angina | Angina, Unstable | Canadian Cardiovascular Society classification of angina | Ischemia | Atypical chest pain | Myocardial Ischemia Asymptomatic | Progressive exercise test on treadmill Test | Radionuclide Imaging | Echocardiography, Stress | 24 Hour ECG
Item
1. patients with stable (canadian cardiovascular society 1, 2, 3 or 4) or unstable (braunwald class ib, ic, iib, iic, iiib, iiic) angina pectoris and ischemia, or patients with atypical chest pain or even those who are asymptomatic provided they have documented myocardial ischaemia (e.g. treadmill exercise test, radionuclide scintigraphy, stress echocardiography, holter tape);
boolean
C0340288 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C1277207 (UMLS CUI [3])
C0022116 (UMLS CUI [4])
C0262384 (UMLS CUI [5])
C0151744 (UMLS CUI [6,1])
C0231221 (UMLS CUI [6,2])
C0430507 (UMLS CUI [7,1])
C0392366 (UMLS CUI [7,2])
C0034606 (UMLS CUI [8])
C0920208 (UMLS CUI [9])
C0430461 (UMLS CUI [10])
Patient eligible Coronary revascularisation | Angioplasty | Coronary Artery Bypass Surgery
Item
2. patients who are eligible for coronary revascularization (angioplasty or cabg);
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0877341 (UMLS CUI [1,3])
C0162577 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
Lesion Quantity Amenable Placement of stent | Lesion Location Blood Vessels Different | Lesion Location Region Different
Item
3. at least 2 lesions (located in different vessels and in different territories) potentially amenable to stent implantation;
boolean
C0221198 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3900053 (UMLS CUI [1,3])
C0522776 (UMLS CUI [1,4])
C0221198 (UMLS CUI [2,1])
C0450429 (UMLS CUI [2,2])
C0005847 (UMLS CUI [2,3])
C1705242 (UMLS CUI [2,4])
C0221198 (UMLS CUI [3,1])
C0450429 (UMLS CUI [3,2])
C0205147 (UMLS CUI [3,3])
C1705242 (UMLS CUI [3,4])
Blood Vessel Native de novo
Item
4. de novo native vessels;
boolean
C0005847 (UMLS CUI [1,1])
C0302891 (UMLS CUI [1,2])
C1515568 (UMLS CUI [1,3])
Disease Blood Vessel Multiple | Left anterior descending coronary artery stenosis Significant | Therapeutic procedure Lesion Coronary artery Epicardial Major | Double coronary vessel disease | Three Vessel Coronary Disease | Anterior descending branch of left coronary artery | Structure of circumflex branch of left coronary artery | Right coronary artery
Item
5. multivessel disease with at least one significant stenosis in lad and with treatment of the lesion in another major epicardial coronary artery. a two-vessel disease or a three-vessel disease may be viewed as a combination of a side branch and a main epicardial vessel provided they supply different territories; left anterior descending, left circumflex and right coronary artery);
boolean
C0012634 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
C3267165 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0221198 (UMLS CUI [3,2])
C0205042 (UMLS CUI [3,3])
C0442016 (UMLS CUI [3,4])
C0205164 (UMLS CUI [3,5])
C0581375 (UMLS CUI [4])
C3272265 (UMLS CUI [5])
C0226032 (UMLS CUI [6])
C0226037 (UMLS CUI [7])
C0226042 (UMLS CUI [8])
vessels; occlusion Total | vessels; occlusion Total Blood Vessel Epicardial Major | Stenosis Significant Blood Vessel Major | Placement of stent | Myocardial Infarction | Electrocardiographic changes
Item
6. total occluded vessels. one total occluded major epicardial vessel or side branch can be included and targeted as long as one other major vessel has a significant stenosis amenable for sa, provided the age of occlusion is less than one month e.g. recent instability, infarction with ecg changes in the area subtended by the occluded vessel. patients with total occluded vessels of unknown duration or existing longer than one month and a reference over 1.50 mm should not be included, not even as a third or fourth vessel to be dilated;
boolean
C1386685 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C1386685 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
C0005847 (UMLS CUI [2,3])
C0442016 (UMLS CUI [2,4])
C0205164 (UMLS CUI [2,5])
C0678234 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0005847 (UMLS CUI [3,3])
C0205164 (UMLS CUI [3,4])
C0522776 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0855329 (UMLS CUI [6])
Stenosis Significant Diameter | Quantitative Coronary Angiography
Item
7. significant stenosis has been defined as a stenosis of more than 50% in luminal diameter (in at least one view, on visual interpretation or preferably by qca);
boolean
C0678234 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C4054139 (UMLS CUI [2])
Left ventricular ejection fraction
Item
8. left ventricular ejection fraction should be at least 30%.
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Congestive heart failure
Item
1. congestive heart failure;
boolean
C0018802 (UMLS CUI [1])
Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
2. cabg or percutaneous coronary intervention (pci) procedure;
boolean
C0010055 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
major surgery Planned | Heart Valves Operative Surgical Procedures | Left ventricular aneurysm resection | Aortic Aneurysm Excision | Carotid Endarterectomy | surgery for abdominal aortic aneurysm
Item
3. planned need for major surgery (e.g. valve surgery or resection of aortic or left ventricular aneurysm, carotid end-arterectomy, abdominal aortic aneurysm surgery etc.);
boolean
C0679637 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0018826 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0397296 (UMLS CUI [3])
C0003486 (UMLS CUI [4,1])
C0728940 (UMLS CUI [4,2])
C0014099 (UMLS CUI [5])
C2037604 (UMLS CUI [6])
Congenital heart disease
Item
4. congenital heart disease;
boolean
C0152021 (UMLS CUI [1])
Transmural myocardial infarction | Creatine Kinase Abnormal
Item
5. transmural myocardial infarction within the previous seven days and ck has not returned to normal;
boolean
C1400513 (UMLS CUI [1])
C0010287 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
Chest Pain Duration | Creatine kinase (cardiac enzyme) level
Item
6. chest pain lasting longer than 30 minutes within 12 hours pre-procedure, if ck enzymes positive (≥ 2x the normal upper limit).
boolean
C0008031 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C3516327 (UMLS CUI [2])
Cerebrovascular accident
Item
7. history of any cerebrovascular accident;
boolean
C0038454 (UMLS CUI [1])
Left Main Coronary Artery Stenosis, Percentage
Item
8. left main stenosis of 50% or more;
boolean
C2825221 (UMLS CUI [1])
vessels; occlusion Total Blood Vessel Epicardial Major | Intention Treat Blood Vessel Quantity
Item
9. intention to treat more than 1 totally occluded major epicardial vessel;
boolean
C1386685 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C0442016 (UMLS CUI [1,4])
C0205164 (UMLS CUI [1,5])
C1283828 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0005847 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Single coronary vessel disease
Item
10. single vessel (single territory) disease.
boolean
C0581374 (UMLS CUI [1])
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