ID

16034

Beschrijving

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

Trefwoorden

Versies (1)
  1. 26-06-16 26-06-16 -
Geüploaded op

26 juni 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Coronary Heart Disease NCT00185042

Engels

Eligibility Coronary Heart Disease NCT00185042

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
standard:
Beschrijving

ID.1

Datatype

boolean

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

gender and age

Datatype

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.
Beschrijving

cad and indication for coronary angiography

Datatype

boolean

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

ID.4

Datatype

boolean

1. evidence of coronary heart disease
Beschrijving

evidence of coronary heart disease

Datatype

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.
Beschrijving

ID.6

Datatype

boolean

Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
standard:
Beschrijving

ID.7

Datatype

boolean

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

pregnant or lactating

Datatype

boolean

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

previous transplantation

Datatype

boolean

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

ID.10

Datatype

boolean

immunosuppressive agents (cyclosporine, azathioprine);
Beschrijving

immunosuppressive agents

Datatype

boolean

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

prior rifampin therapy

Datatype

boolean

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

prior therapy with anticonvulsants

Datatype

boolean

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

ID.14

Datatype

boolean

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

myocardial infarction or unstable angina

Datatype

boolean

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

clinically significant heart disease

Datatype

boolean

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

coronary artery bypass surgery

Datatype

boolean

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

stroke

Datatype

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%;
Beschrijving

severe symptomatic heart failure

Datatype

boolean

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

uncontrolled diabetes mellitus

Datatype

boolean

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

uncontrolled hypertension

Datatype

boolean

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

kidney disease

Datatype

boolean

Alias
UMLS CUI [1]
C0022658
angiographic:
Beschrijving

ID.23

Datatype

boolean

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

sclerotic lesion

Datatype

boolean

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

occlusion in the left main coronary artery

Datatype

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);
Beschrijving

pci or cabg on target vessel

Datatype

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.
Beschrijving

target vessel bypass graft

Datatype

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C0185098
Terug naar het begin van de pagina

Similar models

Eligibility Coronary Heart Disease NCT00185042

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial