ID

12771

Beskrivning

Same Day Versus Next Day Discharge: Ambulatory Closure Device Percutaneous Intervention; ODM derived from: https://clinicaltrials.gov/show/NCT01230606

Länk

https://clinicaltrials.gov/show/NCT01230606

Nyckelord

Versioner (1)
  1. 2015-12-21 2015-12-21 -
Uppladdad den

21 december 2015

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT01230606

Engelsk

Eligibility Cardiovascular Disease NCT01230606

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. <75 years of age at the time of procedure.
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patient has a type a or b lesion(s)
Beskrivning

lesion

Datatyp

boolean

Alias
UMLS CUI [1]
C0221198
3. femoral access site is amenable to closure with a vascular closure device.
Beskrivning

vascular closure device

Datatyp

boolean

Alias
UMLS CUI [1]
C3504161
4. over 2 hours since the completion of the pci procedure (at least 2 hours must elapse from completion of the pci before subjects become eligible).
Beskrivning

Percutaneous Coronary Intervention

Datatyp

boolean

Alias
UMLS CUI [1]
C1532338
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient has a life expectancy less than 12 months.
Beskrivning

life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
2. patient has recent evidence of an acute coronary syndrome (mi)
Beskrivning

acute coronary syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
3. femoral access is difficult or site is not amenable to closure device
Beskrivning

access femoral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0444454
UMLS CUI [1,2]
C0015811
4. anticoagulants other than unfractionated heparin or bivalirudin were used during the procedure (i.e. enoxaparin).
Beskrivning

anticoagulants

Datatyp

boolean

Alias
UMLS CUI [1]
C0003280
5. patient has sub optimal angiographic outcome or clinical complication(s) during pci
Beskrivning

Percutaneous Coronary Intervention; angiogram

Datatyp

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2]
C0002978
6. the pci occurred in something other than a native coronary artery
Beskrivning

Percutaneous Coronary Intervention; Coronary artery

Datatyp

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2]
C0205042
7. angiographic evidence of thrombus
Beskrivning

thrombus; angiogram

Datatyp

boolean

Alias
UMLS CUI [1]
C0087086
UMLS CUI [2]
C0002978
8. patient has more than 3 stents implanted during this pci
Beskrivning

stent; Percutaneous Coronary Intervention

Datatyp

boolean

Alias
UMLS CUI [1]
C0038257
UMLS CUI [2]
C1532338
9. patient has an inr >2, platelet count <100,000 or hematocrit <25
Beskrivning

International Normalized Ratio; Platelet Count measurement; Platelet hematocrit measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0525032
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0474566
10. occlusion of major side branch during pci of >1.5mm
Beskrivning

occlusion; Percutaneous Coronary Intervention

Datatyp

boolean

Alias
UMLS CUI [1]
C1947917
UMLS CUI [2]
C1532338
11. patient has ejection fraction ≤30%
Beskrivning

ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0232174
12. known allergy to pci procedural medications
Beskrivning

hypersensitivity Percutaneous Coronary Intervention medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1532338
UMLS CUI [1,3]
C0013227
13. patient reports living further than 30 minutes from a hospital by ambulance.
Beskrivning

residence patient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0030705
14. patient provides informed consent and agrees to the follow-up schedule.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
15. evidence of vascular complication(s) (e.g. dissection, hematoma, bleeding) peri-procedure
Beskrivning

vascular complication

Datatyp

boolean

Alias
UMLS CUI [1]
C1112391
16. patient is pregnant
Beskrivning

pregnant

Datatyp

boolean

Alias
UMLS CUI [1]
C0549206
17. evidence of infection (e.g. fever, pus, swelling) peri-procedure
Beskrivning

infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
18. patients with chronic renal insufficiency (e.g. serum creatinine ≥1.5 mg/dl)
Beskrivning

chronic renal insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C0022661
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Similar models

Eligibility Cardiovascular Disease NCT01230606

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
1. <75 years of age at the time of procedure.
boolean
C0001779 (UMLS CUI [1])
lesion
Item
2. patient has a type a or b lesion(s)
boolean
C0221198 (UMLS CUI [1])
vascular closure device
Item
3. femoral access site is amenable to closure with a vascular closure device.
boolean
C3504161 (UMLS CUI [1])
Percutaneous Coronary Intervention
Item
4. over 2 hours since the completion of the pci procedure (at least 2 hours must elapse from completion of the pci before subjects become eligible).
boolean
C1532338 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
life expectancy
Item
1. patient has a life expectancy less than 12 months.
boolean
C0023671 (UMLS CUI [1])
acute coronary syndrome
Item
2. patient has recent evidence of an acute coronary syndrome (mi)
boolean
C0948089 (UMLS CUI [1])
access femoral
Item
3. femoral access is difficult or site is not amenable to closure device
boolean
C0444454 (UMLS CUI [1,1])
C0015811 (UMLS CUI [1,2])
anticoagulants
Item
4. anticoagulants other than unfractionated heparin or bivalirudin were used during the procedure (i.e. enoxaparin).
boolean
C0003280 (UMLS CUI [1])
Percutaneous Coronary Intervention; angiogram
Item
5. patient has sub optimal angiographic outcome or clinical complication(s) during pci
boolean
C1532338 (UMLS CUI [1])
C0002978 (UMLS CUI [2])
Percutaneous Coronary Intervention; Coronary artery
Item
6. the pci occurred in something other than a native coronary artery
boolean
C1532338 (UMLS CUI [1])
C0205042 (UMLS CUI [2])
thrombus; angiogram
Item
7. angiographic evidence of thrombus
boolean
C0087086 (UMLS CUI [1])
C0002978 (UMLS CUI [2])
stent; Percutaneous Coronary Intervention
Item
8. patient has more than 3 stents implanted during this pci
boolean
C0038257 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
International Normalized Ratio; Platelet Count measurement; Platelet hematocrit measurement
Item
9. patient has an inr >2, platelet count <100,000 or hematocrit <25
boolean
C0525032 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0474566 (UMLS CUI [3])
occlusion; Percutaneous Coronary Intervention
Item
10. occlusion of major side branch during pci of >1.5mm
boolean
C1947917 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
ejection fraction
Item
11. patient has ejection fraction ≤30%
boolean
C0232174 (UMLS CUI [1])
hypersensitivity Percutaneous Coronary Intervention medication
Item
12. known allergy to pci procedural medications
boolean
C0020517 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
residence patient
Item
13. patient reports living further than 30 minutes from a hospital by ambulance.
boolean
C0237096 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
informed consent
Item
14. patient provides informed consent and agrees to the follow-up schedule.
boolean
C0021430 (UMLS CUI [1])
vascular complication
Item
15. evidence of vascular complication(s) (e.g. dissection, hematoma, bleeding) peri-procedure
boolean
C1112391 (UMLS CUI [1])
pregnant
Item
16. patient is pregnant
boolean
C0549206 (UMLS CUI [1])
infection
Item
17. evidence of infection (e.g. fever, pus, swelling) peri-procedure
boolean
C0009450 (UMLS CUI [1])
chronic renal insufficiency
Item
18. patients with chronic renal insufficiency (e.g. serum creatinine ≥1.5 mg/dl)
boolean
C0022661 (UMLS CUI [1])
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