ID

28750

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00541203

Stichworte

Versionen (1)
  1. 31.01.18 31.01.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

31. Januar 2018

DOI

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Creative Commons BY 4.0
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Eligibility Coronary Disease NCT00541203

Englisch

Eligibility Coronary Disease NCT00541203

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Chest Pain | Symptoms Suggestive of Coronary Artery Disease

Datentyp

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.
Beschreibung

Pharmacologic and exercise stress test SPECT

Datentyp

boolean

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

Relationship Inconsistent | Clinical Test Result | Stress test Result

Datentyp

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.
Beschreibung

Cardiac Catheterization Scheduled

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

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

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

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%)
Beschreibung

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

Datentyp

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.
Beschreibung

Hypertensive disease | Left Ventricular Hypertrophy Severe | Cor pulmonale

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Informed Consent Unable | Informed Consent Refused

Datentyp

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.
Beschreibung

Patient Psychological Inappropriate | Claustrophobia Extreme

Datentyp

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.
Beschreibung

Pregnancy | Pregnancy status Unknown

Datentyp

boolean

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

Age

Datentyp

boolean

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

Allergic reaction to iodinated contrast material | Premedication Receive Unable

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Computed tomography imaging | Administration Contrast Media

Datentyp

boolean

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

Eligibility Coronary Disease NCT00541203

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