ID

20471

Beschreibung

Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia; ODM derived from: https://clinicaltrials.gov/show/NCT00944970

Link

https://clinicaltrials.gov/show/NCT00944970

Stichworte

Versionen (1)
  1. 24.02.17 24.02.17 -
Hochgeladen am

24. Februar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00944970

Englisch

Eligibility Coronary Artery Disease NCT00944970

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
able to understand and sign an informed consent form.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are of childbearing potential.
Beschreibung

Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
very low likelihood of coronary artery disease (by american heart association and american college of cardiology standards).
Beschreibung

Coronary Artery Disease Probability Very low

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0033204
UMLS CUI [1,3]
C0442811
documented history of acute myocardial infarction within 30 days.
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
percutaneous coronary intervention or coronary bypass graft surgery within 3 years, unless typical or atypical anginal symptoms are present.
Beschreibung

Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery | Typical angina | Atypical angina

Datentyp

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2]
C0010055
UMLS CUI [3]
C1998435
UMLS CUI [4]
C0741026
reactive airway disease or other contraindication that preclude a patient from receiving adenosine.
Beschreibung

Reactive airway disease Excludes Adenosine | Medical contraindication Adenosine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3714497
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0001443
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0001443
previous heart transplant or listed to receive a heart transplant.
Beschreibung

Heart Transplantation | Heart Transplantation Scheduled

Datentyp

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2,1]
C0018823
UMLS CUI [2,2]
C0205539
cardiomyopathy (idiopathic dilated, restrictive, hypertrophic).
Beschreibung

Cardiomyopathy, Dilated | Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0007193
UMLS CUI [2]
C0007196
UMLS CUI [3]
C0007194
history of hemodynamically significant supraventricular tachycardia or sustained ventricular tachycardia.
Beschreibung

Supraventricular tachycardia Hemodynamic Significant | Sustained ventricular tachycardia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0039240
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
UMLS CUI [2]
C0750197
presence of second- or third-degree av block (in the absence of permanent pacemaker).
Beschreibung

Second degree atrioventricular block | Complete atrioventricular block | permanent pacemaker Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3,1]
C0281945
UMLS CUI [3,2]
C0332197
left ventricular ejection fraction greater than 35%, known prior to the first imaging procedure.
Beschreibung

Left ventricular ejection fraction | Imaging Techniques

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0079595
presence of advanced heart failure, new york heart association class iv.
Beschreibung

Heart failure Advanced New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1275491
history of vasospastic/prinzmetal angina.
Beschreibung

Angina Pectoris, Variant

Datentyp

boolean

Alias
UMLS CUI [1]
C0002963
active (under treatment) cancer (except skin cancers).
Beschreibung

Malignant Neoplasm Treating | Skin carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1522326
UMLS CUI [2]
C0699893
inability to discontinue antianginal medications, aggrenox®, dipyridamole, and xanthine-containing drugs and foods (including caffeine) as required prior to each imaging procedure.
Beschreibung

Antianginals Discontinue Unable | Aggrenox | Dipyridamole | xanthine | Caffeine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3537168
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0732282
UMLS CUI [3]
C0012582
UMLS CUI [4]
C0043314
UMLS CUI [5]
C0006644
UMLS CUI [6]
C0079595
previous participation in a study of binodenoson.
Beschreibung

Study Subject Participation Status | binodenoson

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0530859
any physical or psychosocial condition that, based on the investigator's judgment, would prevent the patient from completing the study.
Beschreibung

Physical Condition Preventing Protocol Compliance | Psychosocial status Preventing Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3714565
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0337459
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0525058
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT00944970

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
able to understand and sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential
Item
women who are of childbearing potential.
boolean
C3831118 (UMLS CUI [1])
Coronary Artery Disease Probability Very low
Item
very low likelihood of coronary artery disease (by american heart association and american college of cardiology standards).
boolean
C1956346 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
C0442811 (UMLS CUI [1,3])
Myocardial Infarction
Item
documented history of acute myocardial infarction within 30 days.
boolean
C0027051 (UMLS CUI [1])
Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery | Typical angina | Atypical angina
Item
percutaneous coronary intervention or coronary bypass graft surgery within 3 years, unless typical or atypical anginal symptoms are present.
boolean
C1532338 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1998435 (UMLS CUI [3])
C0741026 (UMLS CUI [4])
Reactive airway disease Excludes Adenosine | Medical contraindication Adenosine
Item
reactive airway disease or other contraindication that preclude a patient from receiving adenosine.
boolean
C3714497 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0001443 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0001443 (UMLS CUI [2,2])
Heart Transplantation | Heart Transplantation Scheduled
Item
previous heart transplant or listed to receive a heart transplant.
boolean
C0018823 (UMLS CUI [1])
C0018823 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Cardiomyopathy, Dilated | Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy
Item
cardiomyopathy (idiopathic dilated, restrictive, hypertrophic).
boolean
C0007193 (UMLS CUI [1])
C0007196 (UMLS CUI [2])
C0007194 (UMLS CUI [3])
Supraventricular tachycardia Hemodynamic Significant | Sustained ventricular tachycardia
Item
history of hemodynamically significant supraventricular tachycardia or sustained ventricular tachycardia.
boolean
C0039240 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0750197 (UMLS CUI [2])
Second degree atrioventricular block | Complete atrioventricular block | permanent pacemaker Absent
Item
presence of second- or third-degree av block (in the absence of permanent pacemaker).
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0281945 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Left ventricular ejection fraction | Imaging Techniques
Item
left ventricular ejection fraction greater than 35%, known prior to the first imaging procedure.
boolean
C0428772 (UMLS CUI [1])
C0079595 (UMLS CUI [2])
Heart failure Advanced New York Heart Association Classification
Item
presence of advanced heart failure, new york heart association class iv.
boolean
C0018801 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Angina Pectoris, Variant
Item
history of vasospastic/prinzmetal angina.
boolean
C0002963 (UMLS CUI [1])
Malignant Neoplasm Treating | Skin carcinoma
Item
active (under treatment) cancer (except skin cancers).
boolean
C0006826 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0699893 (UMLS CUI [2])
Antianginals Discontinue Unable | Aggrenox | Dipyridamole | xanthine | Caffeine
Item
inability to discontinue antianginal medications, aggrenox®, dipyridamole, and xanthine-containing drugs and foods (including caffeine) as required prior to each imaging procedure.
boolean
C3537168 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0732282 (UMLS CUI [2])
C0012582 (UMLS CUI [3])
C0043314 (UMLS CUI [4])
C0006644 (UMLS CUI [5])
C0079595 (UMLS CUI [6])
Study Subject Participation Status | binodenoson
Item
previous participation in a study of binodenoson.
boolean
C2348568 (UMLS CUI [1])
C0530859 (UMLS CUI [2])
Physical Condition Preventing Protocol Compliance | Psychosocial status Preventing Protocol Compliance
Item
any physical or psychosocial condition that, based on the investigator's judgment, would prevent the patient from completing the study.
boolean
C3714565 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0337459 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
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