ID

28750

Beskrivning

Cardiac Computed Tomography In the Management of Patients With indeterminAte or inConclusive Stress Tests; ODM derived from: https://clinicaltrials.gov/show/NCT00541203

Länk

https://clinicaltrials.gov/show/NCT00541203

Nyckelord

  1. 2018-01-31 2018-01-31 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

31 januari 2018

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Coronary Disease NCT00541203

Eligibility Coronary Disease NCT00541203

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. chest pain or other symptoms suggestive of coronary artery disease.
Beskrivning

Chest Pain | Symptoms Suggestive of Coronary Artery Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0008031
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0332299
UMLS CUI [2,3]
C1956346
2. pharmacologic/exercise stress test with spect within the past 3 months.
Beskrivning

Pharmacologic and exercise stress test SPECT

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1998158
UMLS CUI [1,2]
C0040399
3. "discordant" clinical and stress results as outlined above.
Beskrivning

Relationship Inconsistent | Clinical Test Result | Stress test Result

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0442809
UMLS CUI [2]
C0456984
UMLS CUI [3,1]
C0015260
UMLS CUI [3,2]
C1274040
4. scheduled to undergo cardiac catheterization.
Beskrivning

Cardiac Catheterization Scheduled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018795
UMLS CUI [1,2]
C0205539
5. able to provide informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
6. age equal to or greater than 18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. presence of pre-existing cad (prior myocardial infarction, prior angiographic evidence of significant coronary artery disease, prior coronary bypass surgery) or cardiomyopathy (ejection fraction < 45%)
Beskrivning

Coronary Artery Disease Pre-existing | Myocardial Infarction | Coronary Artery Disease Angiography | Coronary Artery Bypass Surgery | Cardiomyopathy | Cardiac ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C1956346
UMLS CUI [3,2]
C0002978
UMLS CUI [4]
C0010055
UMLS CUI [5]
C0878544
UMLS CUI [6]
C0232174
2. history of hypertension with severe left ventricular hypertrophy, history of cor pulmonale.
Beskrivning

Hypertensive disease | Left Ventricular Hypertrophy Severe | Cor pulmonale

Datatyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C0149721
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0034072
3. renal insufficiency (creatinine ≥1.6) or renal failure requiring dialysis.
Beskrivning

Renal Insufficiency | Creatinine measurement, serum | Kidney Failure Requirement Dialysis

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C0035078
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0011946
4. inability or refusal to provide informed consent.
Beskrivning

Informed Consent Unable | Informed Consent Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1705116
5. psychological unsuitability or extreme claustrophobia.
Beskrivning

Patient Psychological Inappropriate | Claustrophobia Extreme

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0205486
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0008909
UMLS CUI [2,2]
C0205403
6. pregnancy or unknown pregnancy status.
Beskrivning

Pregnancy | Pregnancy status Unknown

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0552579
UMLS CUI [2,2]
C0439673
7. age less than 18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
8. patients with known allergy to iodinated contrast, unable to tolerate pre-medication.
Beskrivning

Allergic reaction to iodinated contrast material | Premedication Receive Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C2215738
UMLS CUI [2,1]
C0033045
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C1299582
9. inability to tolerate beta-blockers, including those with copd or asthma requiring maintenance inhaled bronchodilators or steroids, complete heart block, second-degree atrioventricular block.
Beskrivning

Adrenergic beta-Antagonists Receive Unable | Chronic Obstructive Airway Disease | Asthma | Inhaled bronchodilator prescribed (COPD) | Inhaled steroids use | Complete atrioventricular block | Second degree atrioventricular block

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001645
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0024117
UMLS CUI [3]
C0004096
UMLS CUI [4]
C1736641
UMLS CUI [5]
C0586793
UMLS CUI [6]
C0151517
UMLS CUI [7]
C0264906
10. computed tomography imaging, or contrast administration, within the past 48 hours.
Beskrivning

Computed tomography imaging | Administration Contrast Media

Datatyp

boolean

Alias
UMLS CUI [1]
C0729619
UMLS CUI [2,1]
C1533734
UMLS CUI [2,2]
C0009924

Similar models

Eligibility Coronary Disease NCT00541203

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Chest Pain | Symptoms Suggestive of Coronary Artery Disease
Item
1. chest pain or other symptoms suggestive of coronary artery disease.
boolean
C0008031 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C1956346 (UMLS CUI [2,3])
Pharmacologic and exercise stress test SPECT
Item
2. pharmacologic/exercise stress test with spect within the past 3 months.
boolean
C1998158 (UMLS CUI [1,1])
C0040399 (UMLS CUI [1,2])
Relationship Inconsistent | Clinical Test Result | Stress test Result
Item
3. "discordant" clinical and stress results as outlined above.
boolean
C0439849 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C0456984 (UMLS CUI [2])
C0015260 (UMLS CUI [3,1])
C1274040 (UMLS CUI [3,2])
Cardiac Catheterization Scheduled
Item
4. scheduled to undergo cardiac catheterization.
boolean
C0018795 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Informed Consent
Item
5. able to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
6. age equal to or greater than 18 years.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Coronary Artery Disease Pre-existing | Myocardial Infarction | Coronary Artery Disease Angiography | Coronary Artery Bypass Surgery | Cardiomyopathy | Cardiac ejection fraction
Item
1. presence of pre-existing cad (prior myocardial infarction, prior angiographic evidence of significant coronary artery disease, prior coronary bypass surgery) or cardiomyopathy (ejection fraction < 45%)
boolean
C1956346 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C1956346 (UMLS CUI [3,1])
C0002978 (UMLS CUI [3,2])
C0010055 (UMLS CUI [4])
C0878544 (UMLS CUI [5])
C0232174 (UMLS CUI [6])
Hypertensive disease | Left Ventricular Hypertrophy Severe | Cor pulmonale
Item
2. history of hypertension with severe left ventricular hypertrophy, history of cor pulmonale.
boolean
C0020538 (UMLS CUI [1])
C0149721 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0034072 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum | Kidney Failure Requirement Dialysis
Item
3. renal insufficiency (creatinine ≥1.6) or renal failure requiring dialysis.
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0035078 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0011946 (UMLS CUI [3,3])
Informed Consent Unable | Informed Consent Refused
Item
4. inability or refusal to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
Patient Psychological Inappropriate | Claustrophobia Extreme
Item
5. psychological unsuitability or extreme claustrophobia.
boolean
C0030705 (UMLS CUI [1,1])
C0205486 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0008909 (UMLS CUI [2,1])
C0205403 (UMLS CUI [2,2])
Pregnancy | Pregnancy status Unknown
Item
6. pregnancy or unknown pregnancy status.
boolean
C0032961 (UMLS CUI [1])
C0552579 (UMLS CUI [2,1])
C0439673 (UMLS CUI [2,2])
Age
Item
7. age less than 18 years.
boolean
C0001779 (UMLS CUI [1])
Allergic reaction to iodinated contrast material | Premedication Receive Unable
Item
8. patients with known allergy to iodinated contrast, unable to tolerate pre-medication.
boolean
C2215738 (UMLS CUI [1])
C0033045 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Adrenergic beta-Antagonists Receive Unable | Chronic Obstructive Airway Disease | Asthma | Inhaled bronchodilator prescribed (COPD) | Inhaled steroids use | Complete atrioventricular block | Second degree atrioventricular block
Item
9. inability to tolerate beta-blockers, including those with copd or asthma requiring maintenance inhaled bronchodilators or steroids, complete heart block, second-degree atrioventricular block.
boolean
C0001645 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0024117 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
C1736641 (UMLS CUI [4])
C0586793 (UMLS CUI [5])
C0151517 (UMLS CUI [6])
C0264906 (UMLS CUI [7])
Computed tomography imaging | Administration Contrast Media
Item
10. computed tomography imaging, or contrast administration, within the past 48 hours.
boolean
C0729619 (UMLS CUI [1])
C1533734 (UMLS CUI [2,1])
C0009924 (UMLS CUI [2,2])

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