ID

16034

Beschreibung

Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00185042

Link

https://clinicaltrials.gov/show/NCT00185042

Stichworte

Versionen (1)
  1. 26.06.16 26.06.16 -
Hochgeladen am

26. Juni 2016

DOI

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Creative Commons BY 4.0
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Eligibility Coronary Heart Disease NCT00185042

Englisch

Eligibility Coronary Heart Disease NCT00185042

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
standard:
Beschreibung

ID.1

Datentyp

boolean

1. male or female subjects, age 18 years or greater; and
Beschreibung

gender and age

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0079399
2. diagnosed or suspected coronary artery disease with a clinical indication for coronary angiography.
Beschreibung

cad and indication for coronary angiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0085532
angiographic:
Beschreibung

ID.4

Datentyp

boolean

1. evidence of coronary heart disease
Beschreibung

evidence of coronary heart disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3887511
UMLS CUI [1,2]
C0010068
2. identification of a target native coronary artery for the plaque volume measurement.
Beschreibung

ID.6

Datentyp

boolean

Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
standard:
Beschreibung

ID.7

Datentyp

boolean

1. breast feeding or lactating women, or women who have had a pregnancy (regardless of outcome) within the past 12 months;
Beschreibung

pregnant or lactating

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
2. previous heart or other organ transplantation;
Beschreibung

previous transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0040732
3. treatment with any of the following agents within 4 weeks prior to randomization:
Beschreibung

ID.10

Datentyp

boolean

immunosuppressive agents (cyclosporine, azathioprine);
Beschreibung

immunosuppressive agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0021081
rifampin; and
Beschreibung

prior rifampin therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0035608
phenytoin, phenobarbital, valproic acid, or other anticonvulsants.
Beschreibung

prior therapy with anticonvulsants

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0003286
4. any of the following manifestations of cardiac disease:
Beschreibung

ID.14

Datentyp

boolean

myocardial infarction or unstable angina within 24 hours prior to randomization or clinically unstable;
Beschreibung

myocardial infarction or unstable angina

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
clinically significant heart disease; and
Beschreibung

clinically significant heart disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C2826293
coronary artery bypass surgery within previous 3 months.
Beschreibung

coronary artery bypass surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0010055
5. stroke (cva) within previous 3 months;
Beschreibung

stroke

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
6. evidence of severe symptomatic heart failure (nyha class iii or iv) or known ejection fraction less than 30%;
Beschreibung

severe symptomatic heart failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0742758
7. uncontrolled diabetes mellitus;
Beschreibung

uncontrolled diabetes mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0421258
8. uncontrolled hypertension; and
Beschreibung

uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
9. nephrotic syndrome, significant nephropathy, or other significant renal disease.
Beschreibung

kidney disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0022658
angiographic:
Beschreibung

ID.23

Datentyp

boolean

1. presence of any lesion with greater than 50% reduction in lumen diameter; or
Beschreibung

sclerotic lesion

Datentyp

boolean

Alias
UMLS CUI [1]
C0748541
2. any lesion with a greater than 50% occlusion in the left main coronary artery;
Beschreibung

occlusion in the left main coronary artery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0748541
UMLS CUI [1,2]
C0226031
3. a target vessel, including any of its branches, that has undergone or will be undergoing coronary artery bypass grafting (cabg) or percutaneous coronary intervention (pci);
Beschreibung

pci or cabg on target vessel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C0010055
UMLS CUI [2,1]
C0449618
UMLS CUI [2,2]
C1532338
4. a target vessel that is itself a bypass graft.
Beschreibung

target vessel bypass graft

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C0185098
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Ähnliche Modelle

Eligibility Coronary Heart Disease NCT00185042

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
standard:
boolean
gender and age
Item
1. male or female subjects, age 18 years or greater; and
boolean
C0001779 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
cad and indication for coronary angiography
Item
2. diagnosed or suspected coronary artery disease with a clinical indication for coronary angiography.
boolean
C1956346 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0085532 (UMLS CUI [1,3])
ID.4
Item
angiographic:
boolean
evidence of coronary heart disease
Item
1. evidence of coronary heart disease
boolean
C3887511 (UMLS CUI [1,1])
C0010068 (UMLS CUI [1,2])
ID.6
Item
2. identification of a target native coronary artery for the plaque volume measurement.
boolean
Item Group
C0680251 (UMLS CUI)
ID.7
Item
standard:
boolean
pregnant or lactating
Item
1. breast feeding or lactating women, or women who have had a pregnancy (regardless of outcome) within the past 12 months;
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
previous transplantation
Item
2. previous heart or other organ transplantation;
boolean
C0040732 (UMLS CUI [1])
ID.10
Item
3. treatment with any of the following agents within 4 weeks prior to randomization:
boolean
immunosuppressive agents
Item
immunosuppressive agents (cyclosporine, azathioprine);
boolean
C1514463 (UMLS CUI [1,1])
C0021081 (UMLS CUI [1,2])
prior rifampin therapy
Item
rifampin; and
boolean
C1514463 (UMLS CUI [1,1])
C0035608 (UMLS CUI [1,2])
prior therapy with anticonvulsants
Item
phenytoin, phenobarbital, valproic acid, or other anticonvulsants.
boolean
C1514463 (UMLS CUI [1,1])
C0003286 (UMLS CUI [1,2])
ID.14
Item
4. any of the following manifestations of cardiac disease:
boolean
myocardial infarction or unstable angina
Item
myocardial infarction or unstable angina within 24 hours prior to randomization or clinically unstable;
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
clinically significant heart disease
Item
clinically significant heart disease; and
boolean
C0018799 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
coronary artery bypass surgery
Item
coronary artery bypass surgery within previous 3 months.
boolean
C0010055 (UMLS CUI [1])
stroke
Item
5. stroke (cva) within previous 3 months;
boolean
C0038454 (UMLS CUI [1])
severe symptomatic heart failure
Item
6. evidence of severe symptomatic heart failure (nyha class iii or iv) or known ejection fraction less than 30%;
boolean
C0742758 (UMLS CUI [1])
uncontrolled diabetes mellitus
Item
7. uncontrolled diabetes mellitus;
boolean
C0421258 (UMLS CUI [1])
uncontrolled hypertension
Item
8. uncontrolled hypertension; and
boolean
C1868885 (UMLS CUI [1])
kidney disease
Item
9. nephrotic syndrome, significant nephropathy, or other significant renal disease.
boolean
C0022658 (UMLS CUI [1])
ID.23
Item
angiographic:
boolean
sclerotic lesion
Item
1. presence of any lesion with greater than 50% reduction in lumen diameter; or
boolean
C0748541 (UMLS CUI [1])
occlusion in the left main coronary artery
Item
2. any lesion with a greater than 50% occlusion in the left main coronary artery;
boolean
C0748541 (UMLS CUI [1,1])
C0226031 (UMLS CUI [1,2])
pci or cabg on target vessel
Item
3. a target vessel, including any of its branches, that has undergone or will be undergoing coronary artery bypass grafting (cabg) or percutaneous coronary intervention (pci);
boolean
C0449618 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
C0449618 (UMLS CUI [2,1])
C1532338 (UMLS CUI [2,2])
target vessel bypass graft
Item
4. a target vessel that is itself a bypass graft.
boolean
C0449618 (UMLS CUI [1,1])
C0185098 (UMLS CUI [1,2])
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