ID

20342

Description

Trial in Subjects Undergoing Cardiac Catheterization With Planned Percutaneous Coronary Intervention With Stenting; ODM derived from: https://clinicaltrials.gov/show/NCT00357968

Link

https://clinicaltrials.gov/show/NCT00357968

Keywords

Versions (1)
  1. 2/20/17 2/20/17 -
Uploaded on

February 20, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00357968

English

Eligibility Coronary Artery Disease NCT00357968

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects greater than or equal to 18 years of age undergoing cardiac catheterization with planned percutaneous coronary intervention (if coronary anatomy is suitable) for an indication of chest pain +/or anginal equivalent felt by the treating physician to be related to coronary ischemia.
Description

Age | Cardiac Catheterization | Percutaneous Coronary Intervention Planned | Chest Pain Relationship Ischaemia coronary artery origin | Angina Pectoris Relationship Ischaemia coronary artery origin

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0018795
UMLS CUI [3,1]
C1532338
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0008031
UMLS CUI [4,2]
C0439849
UMLS CUI [4,3]
C0542060
UMLS CUI [5,1]
C0002962
UMLS CUI [5,2]
C0439849
UMLS CUI [5,3]
C0542060
at least one of the following (a through c):
Description

criteria Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1265611
1. functional study (exercise, or pharmacologic) within the past 8 weeks consistent with ischemia as manifested by at least one of the following:
Description

Functional assessment Consistent with Ischemia | Functional assessment Exercise | Functional assessment pharmacological

Data type

boolean

Alias
UMLS CUI [1,1]
C0278372
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0022116
UMLS CUI [2,1]
C0278372
UMLS CUI [2,2]
C0015259
UMLS CUI [3,1]
C0278372
UMLS CUI [3,2]
C0205464
1. a reversible defect on nuclear imaging.
Description

Defect Reversible Radionuclide Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C1457869
UMLS CUI [1,2]
C0205343
UMLS CUI [1,3]
C0034606
2. a reversible wall-motion abnormality by echocardiography.
Description

Cardiac wall motion dysfunction Reversible Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C2024793
UMLS CUI [1,2]
C0205343
UMLS CUI [1,3]
C0013516
3. horizontal or down-sloping st-depressions greater than 1 mm on electrocardiogram (ecg) (if no imaging performed).
Description

ST segment depression Horizontal ECG | ST segment depression Downsloping ECG

Data type

boolean

Alias
UMLS CUI [1,1]
C0520887
UMLS CUI [1,2]
C0205126
UMLS CUI [1,3]
C0013798
UMLS CUI [2,1]
C0520887
UMLS CUI [2,2]
C0443206
UMLS CUI [2,3]
C0013798
2. prior coronary revascularization [percutaneous coronary intervention (pci) or coronary artery bypass graft (cabg)].
Description

Coronary revascularisation | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0877341
UMLS CUI [2]
C1532338
UMLS CUI [3]
C0010055
3. a cardiac catheterization with at least one coronary artery lesion amenable to pci (not yet performed) within 14 days prior to enrollment.
Description

Cardiac Catheterization | Coronary artery Lesion Quantity | Coronary artery Lesion Amenable Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0018795
UMLS CUI [2,1]
C0205042
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0205042
UMLS CUI [3,2]
C0221198
UMLS CUI [3,3]
C3900053
UMLS CUI [3,4]
C1532338
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known creatine kinase-myocardial bands (ck-mb)or cardiac troponin greater than the upper limit of normal at time of screening
Description

Increased CK-MB | Cardiac troponin increased

Data type

boolean

Alias
UMLS CUI [1]
C1834663
UMLS CUI [2]
C1096712
planned pci for acute myocardial infarction (mi) or planned pci within 48 hours of fibrinolytic therapy for st segment elevation myocardial infarction (stemi)
Description

Percutaneous Coronary Intervention Planned Myocardial Infarction | Thrombolytic Therapy ST segment elevation myocardial infarction | Percutaneous Coronary Intervention Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0027051
UMLS CUI [2,1]
C0040044
UMLS CUI [2,2]
C1536220
UMLS CUI [3,1]
C1532338
UMLS CUI [3,2]
C1301732
have cardiogenic shock at the time of screening (systolic blood pressure 90 mm hg associated with clinical evidence of end-organ hypoperfusion, or subjects requiring vasopressors to maintain systolic blood pressure over 90 mm hg and associated with clinical evidence of end-organ hypoperfusion).
Description

Shock, Cardiogenic | Systolic Pressure Associated with End organ Hypoperfusion | Vasoconstrictor Agents Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C0036980
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0743496
UMLS CUI [2,4]
C0442856
UMLS CUI [3,1]
C0042397
UMLS CUI [3,2]
C0686904
refractory ventricular arrhythmias
Description

Ventricular arrhythmia Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C0205269
have new york heart association class iv congestive heart failure
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
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Similar models

Eligibility Coronary Artery Disease NCT00357968

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Cardiac Catheterization | Percutaneous Coronary Intervention Planned | Chest Pain Relationship Ischaemia coronary artery origin | Angina Pectoris Relationship Ischaemia coronary artery origin
Item
subjects greater than or equal to 18 years of age undergoing cardiac catheterization with planned percutaneous coronary intervention (if coronary anatomy is suitable) for an indication of chest pain +/or anginal equivalent felt by the treating physician to be related to coronary ischemia.
boolean
C0001779 (UMLS CUI [1])
C0018795 (UMLS CUI [2])
C1532338 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0008031 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C0542060 (UMLS CUI [4,3])
C0002962 (UMLS CUI [5,1])
C0439849 (UMLS CUI [5,2])
C0542060 (UMLS CUI [5,3])
criteria Quantity
Item
at least one of the following (a through c):
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Functional assessment Consistent with Ischemia | Functional assessment Exercise | Functional assessment pharmacological
Item
1. functional study (exercise, or pharmacologic) within the past 8 weeks consistent with ischemia as manifested by at least one of the following:
boolean
C0278372 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0022116 (UMLS CUI [1,3])
C0278372 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
C0278372 (UMLS CUI [3,1])
C0205464 (UMLS CUI [3,2])
Defect Reversible Radionuclide Imaging
Item
1. a reversible defect on nuclear imaging.
boolean
C1457869 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0034606 (UMLS CUI [1,3])
Cardiac wall motion dysfunction Reversible Echocardiography
Item
2. a reversible wall-motion abnormality by echocardiography.
boolean
C2024793 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
ST segment depression Horizontal ECG | ST segment depression Downsloping ECG
Item
3. horizontal or down-sloping st-depressions greater than 1 mm on electrocardiogram (ecg) (if no imaging performed).
boolean
C0520887 (UMLS CUI [1,1])
C0205126 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,3])
C0520887 (UMLS CUI [2,1])
C0443206 (UMLS CUI [2,2])
C0013798 (UMLS CUI [2,3])
Coronary revascularisation | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
Item
2. prior coronary revascularization [percutaneous coronary intervention (pci) or coronary artery bypass graft (cabg)].
boolean
C0877341 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
Cardiac Catheterization | Coronary artery Lesion Quantity | Coronary artery Lesion Amenable Percutaneous Coronary Intervention
Item
3. a cardiac catheterization with at least one coronary artery lesion amenable to pci (not yet performed) within 14 days prior to enrollment.
boolean
C0018795 (UMLS CUI [1])
C0205042 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0205042 (UMLS CUI [3,1])
C0221198 (UMLS CUI [3,2])
C3900053 (UMLS CUI [3,3])
C1532338 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Increased CK-MB | Cardiac troponin increased
Item
known creatine kinase-myocardial bands (ck-mb)or cardiac troponin greater than the upper limit of normal at time of screening
boolean
C1834663 (UMLS CUI [1])
C1096712 (UMLS CUI [2])
Percutaneous Coronary Intervention Planned Myocardial Infarction | Thrombolytic Therapy ST segment elevation myocardial infarction | Percutaneous Coronary Intervention Planned
Item
planned pci for acute myocardial infarction (mi) or planned pci within 48 hours of fibrinolytic therapy for st segment elevation myocardial infarction (stemi)
boolean
C1532338 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C0040044 (UMLS CUI [2,1])
C1536220 (UMLS CUI [2,2])
C1532338 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Shock, Cardiogenic | Systolic Pressure Associated with End organ Hypoperfusion | Vasoconstrictor Agents Patient need for
Item
have cardiogenic shock at the time of screening (systolic blood pressure 90 mm hg associated with clinical evidence of end-organ hypoperfusion, or subjects requiring vasopressors to maintain systolic blood pressure over 90 mm hg and associated with clinical evidence of end-organ hypoperfusion).
boolean
C0036980 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0743496 (UMLS CUI [2,3])
C0442856 (UMLS CUI [2,4])
C0042397 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Ventricular arrhythmia Unresponsive to Treatment
Item
refractory ventricular arrhythmias
boolean
C0085612 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Congestive heart failure New York Heart Association Classification
Item
have new york heart association class iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
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