ID

28680

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01023607

Stichworte

Versionen (1)
  1. 25.01.18 25.01.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. Januar 2018

DOI

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Eligibility Coronary Artery Disease NCT01023607

Englisch

Eligibility Coronary Artery Disease NCT01023607

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

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

Indication Coronary angiography

Datentyp

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).
Beschreibung

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

Datentyp

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).
Beschreibung

Lesion Lipid-rich plaque Optical Coherence Tomography | Other Coding

Datentyp

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.
Beschreibung

Low density lipoprotein cholesterol measurement

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

Life Expectancy Due to Other medical condition

Datentyp

boolean

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

Medical contraindication Atorvastatin | Medical contraindication Rosuvastatin

Datentyp

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.
Beschreibung

Creatinine measurement, serum | End stage renal disease

Datentyp

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).
Beschreibung

Liver Dysfunction Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

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%).
Beschreibung

Congestive heart failure | Left ventricular ejection fraction

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Discontinuation criteria

Datentyp

boolean

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

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datentyp

boolean

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

Myalgia | Myopathy

Datentyp

boolean

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

Follow-up failed

Datentyp

boolean

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

Patient Discontinuation Willing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0600109
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT01023607

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