ID

28680

Beskrivning

Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT) Combined With Intravascular Ultrasound (IVUS); ODM derived from: https://clinicaltrials.gov/show/NCT01023607

Länk

https://clinicaltrials.gov/show/NCT01023607

Nyckelord

Versioner (1)
  1. 2018-01-25 2018-01-25 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 januari 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Coronary Artery Disease NCT01023607

Engelsk

Eligibility Coronary Artery Disease NCT01023607

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age :18-75y
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. clinical indication for coronary angiography (cag).
Beskrivning

Indication Coronary angiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0085532
3. cag demonstrates at least 1 de novo lesion with luminal diameter stenosis between 20% and 70% (visual estimation).
Beskrivning

Lesion de novo Quantity Coronary angiography | Percent Diameter Stenosis Measurement Luminal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0085532
UMLS CUI [2,1]
C3897965
UMLS CUI [2,2]
C0524462
4. oct demonstrates the lesion is a lipid-rich plaque (fct ≤200μm and lipid arc ≥100o).
Beskrivning

Lesion Lipid-rich plaque Optical Coherence Tomography | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C4280983
UMLS CUI [1,3]
C0920367
UMLS CUI [2]
C3846158
5. ldl-c range between 70mg /dl and 160mg /dl.
Beskrivning

Low density lipoprotein cholesterol measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202117
6. patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent.
Beskrivning

Protocol Compliance | Informed Consent | Protocol Compliance Legal Guardian | Informed Consent Legal Guardian

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C0023226
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C0023226
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. life expectancy <12 months due to another medical condition.
Beskrivning

Life Expectancy Due to Other medical condition

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C3843040
2. contraindication to the atorvastatin and rosuvastatin.
Beskrivning

Medical contraindication Atorvastatin | Medical contraindication Rosuvastatin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0286651
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0965129
3. creatinine levels more than 2.0mg/dl or esrd.
Beskrivning

Creatinine measurement, serum | End stage renal disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0022661
4. severe hepatic dysfunction (ast and/or alt more than 3 times the upper limit of normal).
Beskrivning

Liver Dysfunction Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
5. congestive heart failure (left ventricle eject fraction ≤35%).
Beskrivning

Congestive heart failure | Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0428772
6. female of childbearing potential with a positive pregnancy test within 7 days before study, or lactating, or intends to become pregnant during the following 12 months.
Beskrivning

Childbearing Potential Pregnancy test positive | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0240802
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
7. the patient is likely to require coronary bypass surgery, cardiac transplantation, surgical repair or replacement during the course.
Beskrivning

Coronary Artery Bypass Surgery Patient need for Probably | Heart Transplantation Patient need for Probably | Surgical repair Patient need for Probably | Surgical replacement Patient need for Probably

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C0686904
UMLS CUI [1,3]
C0750492
UMLS CUI [2,1]
C0018823
UMLS CUI [2,2]
C0686904
UMLS CUI [2,3]
C0750492
UMLS CUI [3,1]
C0374711
UMLS CUI [3,2]
C0686904
UMLS CUI [3,3]
C0750492
UMLS CUI [4,1]
C4076286
UMLS CUI [4,2]
C0686904
UMLS CUI [4,3]
C0750492
exit criteria
Beskrivning

Discontinuation criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1444662
UMLS CUI [1,2]
C0243161
1. alt/ast ≥ 3times upper limit of normal after enrollment.
Beskrivning

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
2. muscle ache/myopathy.
Beskrivning

Myalgia | Myopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0231528
UMLS CUI [2]
C0026848
3. lose follow-up.
Beskrivning

Follow-up failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0231175
4. patient insists on exit.
Beskrivning

Patient Discontinuation Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0600109
Tillbaka till toppen

Similar models

Eligibility Coronary Artery Disease NCT01023607

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age :18-75y
boolean
C0001779 (UMLS CUI [1])
Indication Coronary angiography
Item
2. clinical indication for coronary angiography (cag).
boolean
C3146298 (UMLS CUI [1,1])
C0085532 (UMLS CUI [1,2])
Lesion de novo Quantity Coronary angiography | Percent Diameter Stenosis Measurement Luminal
Item
3. cag demonstrates at least 1 de novo lesion with luminal diameter stenosis between 20% and 70% (visual estimation).
boolean
C0221198 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0085532 (UMLS CUI [1,4])
C3897965 (UMLS CUI [2,1])
C0524462 (UMLS CUI [2,2])
Lesion Lipid-rich plaque Optical Coherence Tomography | Other Coding
Item
4. oct demonstrates the lesion is a lipid-rich plaque (fct ≤200μm and lipid arc ≥100o).
boolean
C0221198 (UMLS CUI [1,1])
C4280983 (UMLS CUI [1,2])
C0920367 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Low density lipoprotein cholesterol measurement
Item
5. ldl-c range between 70mg /dl and 160mg /dl.
boolean
C0202117 (UMLS CUI [1])
Protocol Compliance | Informed Consent | Protocol Compliance Legal Guardian | Informed Consent Legal Guardian
Item
6. patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0525058 (UMLS CUI [3,1])
C0023226 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C0023226 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Life Expectancy Due to Other medical condition
Item
1. life expectancy <12 months due to another medical condition.
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3843040 (UMLS CUI [1,3])
Medical contraindication Atorvastatin | Medical contraindication Rosuvastatin
Item
2. contraindication to the atorvastatin and rosuvastatin.
boolean
C1301624 (UMLS CUI [1,1])
C0286651 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0965129 (UMLS CUI [2,2])
Creatinine measurement, serum | End stage renal disease
Item
3. creatinine levels more than 2.0mg/dl or esrd.
boolean
C0201976 (UMLS CUI [1])
C0022661 (UMLS CUI [2])
Liver Dysfunction Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
4. severe hepatic dysfunction (ast and/or alt more than 3 times the upper limit of normal).
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Congestive heart failure | Left ventricular ejection fraction
Item
5. congestive heart failure (left ventricle eject fraction ≤35%).
boolean
C0018802 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Childbearing Potential Pregnancy test positive | Breast Feeding | Pregnancy, Planned
Item
6. female of childbearing potential with a positive pregnancy test within 7 days before study, or lactating, or intends to become pregnant during the following 12 months.
boolean
C3831118 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Coronary Artery Bypass Surgery Patient need for Probably | Heart Transplantation Patient need for Probably | Surgical repair Patient need for Probably | Surgical replacement Patient need for Probably
Item
7. the patient is likely to require coronary bypass surgery, cardiac transplantation, surgical repair or replacement during the course.
boolean
C0010055 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0750492 (UMLS CUI [1,3])
C0018823 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0750492 (UMLS CUI [2,3])
C0374711 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C0750492 (UMLS CUI [3,3])
C4076286 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
C0750492 (UMLS CUI [4,3])
Discontinuation criteria
Item
exit criteria
boolean
C1444662 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
1. alt/ast ≥ 3times upper limit of normal after enrollment.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Myalgia | Myopathy
Item
2. muscle ache/myopathy.
boolean
C0231528 (UMLS CUI [1])
C0026848 (UMLS CUI [2])
Follow-up failed
Item
3. lose follow-up.
boolean
C3274571 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Patient Discontinuation Willing
Item
4. patient insists on exit.
boolean
C0030705 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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