ID

20482

Beschreibung

Reduced Anti-Platelet Therapy With Pimecrolimus Drug Eluting Stent (RAPID); ODM derived from: https://clinicaltrials.gov/show/NCT00322543

Link

https://clinicaltrials.gov/show/NCT00322543

Stichworte

Versionen (1)
  1. 25.02.17 25.02.17 -
Hochgeladen am

25. Februar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Disease NCT00322543

Englisch

Eligibility Coronary Disease NCT00322543

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
general inclusion criteria
Beschreibung

Inclusion criteria General

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205246
1. eligible for percutaneous coronary intervention (pci).
Beschreibung

Eligibility Percutaneous Coronary Intervention

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680253
UMLS CUI [1,2]
C1532338
2. documented stable or unstable angina pectoris
Beschreibung

Stable angina | Angina, Unstable

Datentyp

boolean

Alias
UMLS CUI [1]
C0340288
UMLS CUI [2]
C0002965
3. left ventricular ejection fraction (lvef) ≥25%
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
4. acceptable candidate for coronary artery bypass graft surgery (cabg).
Beschreibung

Indication Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0010055
5. target lesion < 25 mm in length with rvd of 2.5 to 3.5 mm with visually estimated stenosis of >= 50 and < 100 %.
Beschreibung

Target Lesion Length | Reference Vessel Diameter | Stenosis Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1444754
UMLS CUI [2,1]
C1706462
UMLS CUI [2,2]
C0005847
UMLS CUI [2,3]
C1301886
UMLS CUI [3,1]
C1261287
UMLS CUI [3,2]
C0439165
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
general exclusion criteria
Beschreibung

Exclusion Criteria General

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205246
1. known sensitivity to pimecrolimus, the polymer (plga) or cobalt chromium.
Beschreibung

Hypersensitivity Pimecrolimus | Hypersensitivity PLGA | Hypersensitivity Cobalt-Chromium

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1099414
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0071599
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0008576
2. planned treatment with any other pci device in the target vessel(s).
Beschreibung

Planned Treatment Percutaneous Coronary Intervention Device Target vessel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3641097
UMLS CUI [1,2]
C1532338
UMLS CUI [1,3]
C0025080
UMLS CUI [1,4]
C0449618
3. mi within 72 hours prior to the index procedure
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
4. the patient is in cardiogenic shock.
Beschreibung

Shock, Cardiogenic

Datentyp

boolean

Alias
UMLS CUI [1]
C0036980
5. cerebrovascular accident (cva) within the past 6 months.
Beschreibung

Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
6. acute or chronic renal dysfunction
Beschreibung

Renal dysfunction | Renal dysfunction chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2,1]
C3279454
UMLS CUI [2,2]
C0205191
7. contraindication to asa or to clopidogrel.
Beschreibung

Medical contraindication Aspirin | Medical contraindication clopidogrel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0070166
8. thrombocytopenia
Beschreibung

Thrombocytopenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0040034
9. active gastrointestinal (gi) bleeding within the past 3 months.
Beschreibung

Gastrointestinal Hemorrhage

Datentyp

boolean

Alias
UMLS CUI [1]
C0017181
10. any prior true anaphylactiod reaction to contrast agents
Beschreibung

Anaphylactoid reaction Contrast Media

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0340865
UMLS CUI [1,2]
C0009924
11. patient is currently taking chronic systemic steroid therapy or systemic immunosuppressant therapy or topical pimecrolimus.
Beschreibung

systemic steroids chronic | Therapeutic immunosuppression Systemic | Pimecrolimus Topical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0021079
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C3213133
12. female of childbearing potential.
Beschreibung

Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
13. life expectancy of less than 24 months due to other medical conditions.
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
14. co-morbid condition(s)
Beschreibung

Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
15. currently participating in another investigational drug or device study
Beschreibung

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
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Ähnliche Modelle

Eligibility Coronary Disease NCT00322543

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria General
Item
general inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Eligibility Percutaneous Coronary Intervention
Item
1. eligible for percutaneous coronary intervention (pci).
boolean
C0680253 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
Stable angina | Angina, Unstable
Item
2. documented stable or unstable angina pectoris
boolean
C0340288 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Left ventricular ejection fraction
Item
3. left ventricular ejection fraction (lvef) ≥25%
boolean
C0428772 (UMLS CUI [1])
Indication Coronary Artery Bypass Surgery
Item
4. acceptable candidate for coronary artery bypass graft surgery (cabg).
boolean
C3146298 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
Target Lesion Length | Reference Vessel Diameter | Stenosis Percentage
Item
5. target lesion < 25 mm in length with rvd of 2.5 to 3.5 mm with visually estimated stenosis of >= 50 and < 100 %.
boolean
C2986546 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
C1706462 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C1261287 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria General
Item
general exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Hypersensitivity Pimecrolimus | Hypersensitivity PLGA | Hypersensitivity Cobalt-Chromium
Item
1. known sensitivity to pimecrolimus, the polymer (plga) or cobalt chromium.
boolean
C0020517 (UMLS CUI [1,1])
C1099414 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0071599 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0008576 (UMLS CUI [3,2])
Planned Treatment Percutaneous Coronary Intervention Device Target vessel
Item
2. planned treatment with any other pci device in the target vessel(s).
boolean
C3641097 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
C0449618 (UMLS CUI [1,4])
Myocardial Infarction
Item
3. mi within 72 hours prior to the index procedure
boolean
C0027051 (UMLS CUI [1])
Shock, Cardiogenic
Item
4. the patient is in cardiogenic shock.
boolean
C0036980 (UMLS CUI [1])
Cerebrovascular accident
Item
5. cerebrovascular accident (cva) within the past 6 months.
boolean
C0038454 (UMLS CUI [1])
Renal dysfunction | Renal dysfunction chronic
Item
6. acute or chronic renal dysfunction
boolean
C3279454 (UMLS CUI [1])
C3279454 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Medical contraindication Aspirin | Medical contraindication clopidogrel
Item
7. contraindication to asa or to clopidogrel.
boolean
C1301624 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
Thrombocytopenia
Item
8. thrombocytopenia
boolean
C0040034 (UMLS CUI [1])
Gastrointestinal Hemorrhage
Item
9. active gastrointestinal (gi) bleeding within the past 3 months.
boolean
C0017181 (UMLS CUI [1])
Anaphylactoid reaction Contrast Media
Item
10. any prior true anaphylactiod reaction to contrast agents
boolean
C0340865 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
systemic steroids chronic | Therapeutic immunosuppression Systemic | Pimecrolimus Topical
Item
11. patient is currently taking chronic systemic steroid therapy or systemic immunosuppressant therapy or topical pimecrolimus.
boolean
C2825233 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C3213133 (UMLS CUI [3])
Childbearing Potential
Item
12. female of childbearing potential.
boolean
C3831118 (UMLS CUI [1])
Life Expectancy Due to Other medical condition
Item
13. life expectancy of less than 24 months due to other medical conditions.
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3843040 (UMLS CUI [1,3])
Comorbidity
Item
14. co-morbid condition(s)
boolean
C0009488 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
15. currently participating in another investigational drug or device study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
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