ID

16959

Description

PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions; ODM derived from: https://clinicaltrials.gov/show/NCT00180466

Link

https://clinicaltrials.gov/show/NCT00180466

Keywords

Versions (1)
  1. 8/16/16 8/16/16 -
Uploaded on

August 16, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Disease NCT00180466

English

Eligibility Coronary Disease NCT00180466

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. acute cardiac pain, or angina equivalent, consistent with unstable angina or myocardial infarction, lasting greater than 10 minutes duration within the past 72 hours.
Description

Cardiac pain Duration | Angina Pectoris Equivalent | Unstable Angina Consistent with | Myocardial Infarction Consistent with

Data type

boolean

Alias
UMLS CUI [1,1]
C0423636
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205163
UMLS CUI [3,1]
C0002965
UMLS CUI [3,2]
C0332290
UMLS CUI [4,1]
C0027051
UMLS CUI [4,2]
C0332290
2. patient must have evidence of an acs requiring catheterization documented by the presence of any one of the following conditions:
Description

Acute Coronary Syndrome Evidence Requirement Catheterization

Data type

boolean

Alias
UMLS CUI [1,1]
C0948089
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0007430
1. elevated enzymes (ck-mb or troponin i or troponin t greater than upper limits of normal).
Description

enzymes elevated | Creatine kinase MB measurement | Troponin I measurement | Cardiac troponin T measurement

Data type

boolean

Alias
UMLS CUI [1]
C0743534
UMLS CUI [2]
C0523584
UMLS CUI [3]
C0920210
UMLS CUI [4]
C0523953
2. st depression of >1 mm in 2 or more contiguous leads measured at 40 ms after the j point, in the absence of left ventricular hypertrophy, bundle branch block, paced rhythms, pre-excitation or other ecg artifacts or confounding conditions.
Description

ST segment depression | Left Ventricular Hypertrophy | Bundle-Branch Block | Paced Rhythm | electrocardiogram: preexcitation

Data type

boolean

Alias
UMLS CUI [1]
C0520887
UMLS CUI [2]
C0149721
UMLS CUI [3]
C0006384
UMLS CUI [4]
C2981711
UMLS CUI [5]
C2216050
3. transient st elevation of >1 mm in 2 or more contiguous leads lasting <30 minutes (otherwise same criteria as above).
Description

ST segment elevation Transitory

Data type

boolean

Alias
UMLS CUI [1,1]
C0520886
UMLS CUI [1,2]
C0205374
4. st elevation myocardial infarction with onset >24 hours previously, diagnosed with the typical triad of nitrate unresponsive chest pain lasting >30 minutes, st elevation of >1 mm in 2 or more contiguous leads or new left bundle branch block, and rise and fall of ck-mb isoenzymes.
Description

ST segment elevation myocardial infarction | Chest Pain Unresponsive to Nitrate | ST segment elevation | Left Bundle-Branch Block New | Creatine kinase MB measurement

Data type

boolean

Alias
UMLS CUI [1]
C1536220
UMLS CUI [2,1]
C0008031
UMLS CUI [2,2]
C0205269
UMLS CUI [2,3]
C0028125
UMLS CUI [3]
C0520886
UMLS CUI [4,1]
C0023211
UMLS CUI [4,2]
C0205314
UMLS CUI [5]
C0523584
key clinical exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
1. patient has had a documented acute st-segment elevation myocardial infarction within the past 24 hours.
Description

ST segment elevation myocardial infarction Past 24 Hours

Data type

boolean

Alias
UMLS CUI [1,1]
C1536220
UMLS CUI [1,2]
C3897986
2. known serum creatinine > 2.5 mg/dl.
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
3. decompensated hypotension or heart failure requiring intubation, inotropes, intravenous diuretics or intraaortic balloon counterpulsation.
Description

Hypotension Decompensated | Heart failure Requirement Intubation | Heart failure Requirement Inotropic agent | Heart failure Requirement Diuretics Intravenous | Heart failure Requirement Intra-aortic balloon counterpulsation

Data type

boolean

Alias
UMLS CUI [1,1]
C0020649
UMLS CUI [1,2]
C0205434
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021925
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0304509
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0012798
UMLS CUI [4,4]
C1522726
UMLS CUI [5,1]
C0018801
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C3826111
4. patient has a known hypersensitivity, allergy or contraindication to any of the following: aspirin, heparin, clopidogrel, and ticlopidine or to contrast that cannot be adequately pre-medicated.
Description

Hypersensitivity Aspirin | Hypersensitivity Heparin | Hypersensitivity clopidogrel | Hypersensitivity Ticlopidine | Hypersensitivity Contrast Media | Medical contraindication Aspirin | Medical contraindication Heparin | Medical contraindication clopidogrel | Medical contraindication Ticlopidine | Medical contraindication Contrast Media

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0019134
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0070166
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0040207
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0009924
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0004057
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0019134
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0070166
UMLS CUI [9,1]
C1301624
UMLS CUI [9,2]
C0040207
UMLS CUI [10,1]
C1301624
UMLS CUI [10,2]
C0009924
5. presence of cardiac implants (i.e. implantable defibrillators); however, prior implantation of pacemaker or biventricular pacemaker is permitted.
Description

presence; implant, cardiac | Implantable defibrillator | Implantation of cardiac pacemaker | Implantation of biventricular cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C1442497
UMLS CUI [2]
C0162589
UMLS CUI [3]
C0189842
UMLS CUI [4]
C1997123
6. presence of cardiogenic shock.
Description

Shock, Cardiogenic

Data type

boolean

Alias
UMLS CUI [1]
C0036980
7. patient has a known left ventricular ejection fraction <30%.
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
8. refractory ventricular arrhythmia requiring either intravenous pharmacologic treatment or defibrillator therapy (e.g. ventricular tachycardia or fibrillation).
Description

Ventricular arrhythmia refractory | Pharmacotherapy Intravenous Patient need for | Defibrillator Therapeutic procedure Patient need for | Tachycardia, Ventricular | Ventricular Fibrillation

Data type

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C1522726
UMLS CUI [2,3]
C0686904
UMLS CUI [3,1]
C0180307
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0686904
UMLS CUI [4]
C0042514
UMLS CUI [5]
C0042510
9. acute conduction system disease requiring temporary pacemaker insertion.
Description

Conduction disorder of the heart Requirement Insertion of temporary cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1,1]
C0264886
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0559455
10. patient has had a recent (within 6 months) pci unless the patient is undergoing a staged procedure for dual vessel treatment.
Description

Percutaneous Coronary Intervention | Staged Percutaneous Coronary Intervention Double coronary vessel disease

Data type

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2,1]
C3272260
UMLS CUI [2,2]
C0581375
11. patient has other medical illness (i.e., cancer or congestive heart failure) or recent history of substance abuse that may cause non-compliance with the investigational plan, confound the data interpretation or is associated with an anticipated limited life expectancy less than one year..
Description

Other medical condition Excludes Protocol Compliance | Other medical condition Interferes with research results | Other medical condition Limiting Life Expectancy | Substance Use Disorder Excludes Protocol Compliance | Substance Use Disorder Interferes with research results | Substance Use Disorders Limiting Life Expectancy | Malignant Neoplasms | Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0023671
UMLS CUI [4,1]
C0038586
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C0038586
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0683954
UMLS CUI [6,1]
C0038586
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0023671
UMLS CUI [7]
C0006826
UMLS CUI [8]
C0018802
12. prior participation in this study or patient is currently enrolled in another investigational use device or drug study that has not reached its primary endpoint. if the patient is enrolled in another study that is not investigational, required visits for that trial must not interfere with the conduct of this trial.
Description

Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0013230
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Similar models

Eligibility Coronary Disease NCT00180466

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Cardiac pain Duration | Angina Pectoris Equivalent | Unstable Angina Consistent with | Myocardial Infarction Consistent with
Item
1. acute cardiac pain, or angina equivalent, consistent with unstable angina or myocardial infarction, lasting greater than 10 minutes duration within the past 72 hours.
boolean
C0423636 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4,1])
C0332290 (UMLS CUI [4,2])
Acute Coronary Syndrome Evidence Requirement Catheterization
Item
2. patient must have evidence of an acs requiring catheterization documented by the presence of any one of the following conditions:
boolean
C0948089 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0007430 (UMLS CUI [1,4])
enzymes elevated | Creatine kinase MB measurement | Troponin I measurement | Cardiac troponin T measurement
Item
1. elevated enzymes (ck-mb or troponin i or troponin t greater than upper limits of normal).
boolean
C0743534 (UMLS CUI [1])
C0523584 (UMLS CUI [2])
C0920210 (UMLS CUI [3])
C0523953 (UMLS CUI [4])
ST segment depression | Left Ventricular Hypertrophy | Bundle-Branch Block | Paced Rhythm | electrocardiogram: preexcitation
Item
2. st depression of >1 mm in 2 or more contiguous leads measured at 40 ms after the j point, in the absence of left ventricular hypertrophy, bundle branch block, paced rhythms, pre-excitation or other ecg artifacts or confounding conditions.
boolean
C0520887 (UMLS CUI [1])
C0149721 (UMLS CUI [2])
C0006384 (UMLS CUI [3])
C2981711 (UMLS CUI [4])
C2216050 (UMLS CUI [5])
ST segment elevation Transitory
Item
3. transient st elevation of >1 mm in 2 or more contiguous leads lasting <30 minutes (otherwise same criteria as above).
boolean
C0520886 (UMLS CUI [1,1])
C0205374 (UMLS CUI [1,2])
ST segment elevation myocardial infarction | Chest Pain Unresponsive to Nitrate | ST segment elevation | Left Bundle-Branch Block New | Creatine kinase MB measurement
Item
4. st elevation myocardial infarction with onset >24 hours previously, diagnosed with the typical triad of nitrate unresponsive chest pain lasting >30 minutes, st elevation of >1 mm in 2 or more contiguous leads or new left bundle branch block, and rise and fall of ck-mb isoenzymes.
boolean
C1536220 (UMLS CUI [1])
C0008031 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0028125 (UMLS CUI [2,3])
C0520886 (UMLS CUI [3])
C0023211 (UMLS CUI [4,1])
C0205314 (UMLS CUI [4,2])
C0523584 (UMLS CUI [5])
Exclusion Criteria Main
Item
key clinical exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
ST segment elevation myocardial infarction Past 24 Hours
Item
1. patient has had a documented acute st-segment elevation myocardial infarction within the past 24 hours.
boolean
C1536220 (UMLS CUI [1,1])
C3897986 (UMLS CUI [1,2])
Creatinine measurement, serum
Item
2. known serum creatinine > 2.5 mg/dl.
boolean
C0201976 (UMLS CUI [1])
Hypotension Decompensated | Heart failure Requirement Intubation | Heart failure Requirement Inotropic agent | Heart failure Requirement Diuretics Intravenous | Heart failure Requirement Intra-aortic balloon counterpulsation
Item
3. decompensated hypotension or heart failure requiring intubation, inotropes, intravenous diuretics or intraaortic balloon counterpulsation.
boolean
C0020649 (UMLS CUI [1,1])
C0205434 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021925 (UMLS CUI [2,3])
C0018801 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0304509 (UMLS CUI [3,3])
C0018801 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0012798 (UMLS CUI [4,3])
C1522726 (UMLS CUI [4,4])
C0018801 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C3826111 (UMLS CUI [5,3])
Hypersensitivity Aspirin | Hypersensitivity Heparin | Hypersensitivity clopidogrel | Hypersensitivity Ticlopidine | Hypersensitivity Contrast Media | Medical contraindication Aspirin | Medical contraindication Heparin | Medical contraindication clopidogrel | Medical contraindication Ticlopidine | Medical contraindication Contrast Media
Item
4. patient has a known hypersensitivity, allergy or contraindication to any of the following: aspirin, heparin, clopidogrel, and ticlopidine or to contrast that cannot be adequately pre-medicated.
boolean
C0020517 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0040207 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0009924 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0004057 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0019134 (UMLS CUI [7,2])
C1301624 (UMLS CUI [8,1])
C0070166 (UMLS CUI [8,2])
C1301624 (UMLS CUI [9,1])
C0040207 (UMLS CUI [9,2])
C1301624 (UMLS CUI [10,1])
C0009924 (UMLS CUI [10,2])
presence; implant, cardiac | Implantable defibrillator | Implantation of cardiac pacemaker | Implantation of biventricular cardiac pacemaker
Item
5. presence of cardiac implants (i.e. implantable defibrillators); however, prior implantation of pacemaker or biventricular pacemaker is permitted.
boolean
C1442497 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
C0189842 (UMLS CUI [3])
C1997123 (UMLS CUI [4])
Shock, Cardiogenic
Item
6. presence of cardiogenic shock.
boolean
C0036980 (UMLS CUI [1])
Left ventricular ejection fraction
Item
7. patient has a known left ventricular ejection fraction <30%.
boolean
C0428772 (UMLS CUI [1])
Ventricular arrhythmia refractory | Pharmacotherapy Intravenous Patient need for | Defibrillator Therapeutic procedure Patient need for | Tachycardia, Ventricular | Ventricular Fibrillation
Item
8. refractory ventricular arrhythmia requiring either intravenous pharmacologic treatment or defibrillator therapy (e.g. ventricular tachycardia or fibrillation).
boolean
C0085612 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0013216 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
C0180307 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0686904 (UMLS CUI [3,3])
C0042514 (UMLS CUI [4])
C0042510 (UMLS CUI [5])
Conduction disorder of the heart Requirement Insertion of temporary cardiac pacemaker
Item
9. acute conduction system disease requiring temporary pacemaker insertion.
boolean
C0264886 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0559455 (UMLS CUI [1,3])
Percutaneous Coronary Intervention | Staged Percutaneous Coronary Intervention Double coronary vessel disease
Item
10. patient has had a recent (within 6 months) pci unless the patient is undergoing a staged procedure for dual vessel treatment.
boolean
C1532338 (UMLS CUI [1])
C3272260 (UMLS CUI [2,1])
C0581375 (UMLS CUI [2,2])
Other medical condition Excludes Protocol Compliance | Other medical condition Interferes with research results | Other medical condition Limiting Life Expectancy | Substance Use Disorder Excludes Protocol Compliance | Substance Use Disorder Interferes with research results | Substance Use Disorders Limiting Life Expectancy | Malignant Neoplasms | Congestive heart failure
Item
11. patient has other medical illness (i.e., cancer or congestive heart failure) or recent history of substance abuse that may cause non-compliance with the investigational plan, confound the data interpretation or is associated with an anticipated limited life expectancy less than one year..
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0023671 (UMLS CUI [3,3])
C0038586 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0038586 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0683954 (UMLS CUI [5,3])
C0038586 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0023671 (UMLS CUI [6,3])
C0006826 (UMLS CUI [7])
C0018802 (UMLS CUI [8])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs
Item
12. prior participation in this study or patient is currently enrolled in another investigational use device or drug study that has not reached its primary endpoint. if the patient is enrolled in another study that is not investigational, required visits for that trial must not interfere with the conduct of this trial.
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
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