ID

28718

Beschreibung

Same Day Discharge After Coronary Stenting Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01054365

Link

https://clinicaltrials.gov/show/NCT01054365

Stichworte

Versionen (1)
  1. 27.01.18 27.01.18 -
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See clinicaltrials.gov

Hochgeladen am

27. Januar 2018

DOI

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Eligibility Coronary Artery Disease NCT01054365

Englisch

Eligibility Coronary Artery Disease NCT01054365

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients undergoing single and multivessel stenting of type a, b, and c de novo lesion(s) for the treatment of stable and unstable angina (ccs class i-iv).
Beschreibung

Stenting Vessel Single Type | Stenting Vessel Multiple Type | Lesion de novo | Therapeutic procedure Stable angina CCS Grading Scale Class | Therapeutic procedure Unstable Angina CCS Grading Scale Class

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348535
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C0205171
UMLS CUI [1,4]
C0332307
UMLS CUI [2,1]
C2348535
UMLS CUI [2,2]
C0005847
UMLS CUI [2,3]
C0439064
UMLS CUI [2,4]
C0332307
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1515568
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0340288
UMLS CUI [4,3]
C1879987
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0002965
UMLS CUI [5,3]
C1879987
patients will be treated with thienopyridine oral bolus, either as a pre-treatment or immediately after stenting, and recommended to be continued on daily.
Beschreibung

Thienopyridine Bolus Oral | Pretreatment | Status post Stenting

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1120149
UMLS CUI [1,2]
C1705509
UMLS CUI [1,3]
C1527415
UMLS CUI [2]
C3539076
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C2348535
patients will be anticoagulated with intravenous heparin or bilvalirudin during the procedure and stopped immediately after completion of the procedure.
Beschreibung

Anticoagulation Therapy | Intravenous heparin | Bivalirudin Injection

Datentyp

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2]
C0354566
UMLS CUI [3]
C4034102
arterial access via the femoral artery (sheath 5, 6, 7 or 8 french) and an arteriotomy site suitable for hemostatic device closure. suitability for closure, defined as at least 5 mm from a bifurcation, puncture must not include the artery femoralis profunda or the superficial femoral artery, timi iii coronary flow upon completion of the intervention and left ventricular ejection fraction (lvef) less than 40 per cent.
Beschreibung

Arterial Access Site Femoral artery | Catheter sheath Size | Incision of artery Site | Appropriateness Hemostatic Catheter Closure | TIMI Flow Grade | Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3272298
UMLS CUI [1,2]
C0015801
UMLS CUI [2,1]
C1299426
UMLS CUI [2,2]
C0456389
UMLS CUI [3,1]
C0189583
UMLS CUI [3,2]
C1515974
UMLS CUI [4,1]
C0814634
UMLS CUI [4,2]
C0179761
UMLS CUI [4,3]
C0185003
UMLS CUI [5,1]
C3272266
UMLS CUI [5,2]
C4263591
UMLS CUI [6]
C0428772
patients who live less than an hour away from the hospital.
Beschreibung

Residence Near Hospital

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C1706276
UMLS CUI [1,3]
C0019994
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
age less than 30 years old or greater than 80 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
acute stemi
Beschreibung

ST segment elevation myocardial infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C1536220
non-stemi with documented troponin greater than 10 at presentation to the catheterization laboratory
Beschreibung

Non-ST Elevated Myocardial Infarction | Troponin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C4255010
UMLS CUI [2]
C0523952
cardiogenic shock or hemodynamic instability
Beschreibung

Shock, Cardiogenic | Hemodynamic instability

Datentyp

boolean

Alias
UMLS CUI [1]
C0036980
UMLS CUI [2]
C0948268
severe valvular heart disease
Beschreibung

Heart valve disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205082
any contraindication to anticoagulation
Beschreibung

Medical contraindication Anticoagulation Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003281
pregnancy
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
patients with bleeding diathesis (including thrombocytopenia (platelets less than 100,000), thrombasthenia, von willebrand's disease, or anemia (hgb less than 10 mg per dl, hct less than 30) or coagulopathy
Beschreibung

Bleeding tendency | Thrombocytopenia | Platelet Count measurement | Thrombasthenia | von Willebrand Disease | Anemia | Hemoglobin measurement | Hematocrit level | Blood Coagulation Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0040034
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0040015
UMLS CUI [5]
C0042974
UMLS CUI [6]
C0002871
UMLS CUI [7]
C0518015
UMLS CUI [8]
C0518014
UMLS CUI [9]
C0005779
patients with a creatinine greater than 1.5 mg/ml
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
patients with an inr greater than 1.5
Beschreibung

International Normalized Ratio

Datentyp

boolean

Alias
UMLS CUI [1]
C0525032
patients with cancer or autoimmune disease
Beschreibung

Malignant Neoplasms | Autoimmune Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0004364
patients who live greater than 60 minutes away from the hospital
Beschreibung

Residence Remote Hospital

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0205157
UMLS CUI [1,3]
C0019994
patients who will not be able to follow-up
Beschreibung

Follow-up Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1299582
patients with inadequate social or home support (homeless, lives alone, etc)
Beschreibung

Social support Inadequate | Support at home Inadequate | Homeless | Living Alone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037438
UMLS CUI [1,2]
C0205412
UMLS CUI [2,1]
C3161503
UMLS CUI [2,2]
C0205412
UMLS CUI [3]
C0237154
UMLS CUI [4]
C0439044
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT01054365

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Stenting Vessel Single Type | Stenting Vessel Multiple Type | Lesion de novo | Therapeutic procedure Stable angina CCS Grading Scale Class | Therapeutic procedure Unstable Angina CCS Grading Scale Class
Item
patients undergoing single and multivessel stenting of type a, b, and c de novo lesion(s) for the treatment of stable and unstable angina (ccs class i-iv).
boolean
C2348535 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
C2348535 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C0439064 (UMLS CUI [2,3])
C0332307 (UMLS CUI [2,4])
C0221198 (UMLS CUI [3,1])
C1515568 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0340288 (UMLS CUI [4,2])
C1879987 (UMLS CUI [4,3])
C0087111 (UMLS CUI [5,1])
C0002965 (UMLS CUI [5,2])
C1879987 (UMLS CUI [5,3])
Thienopyridine Bolus Oral | Pretreatment | Status post Stenting
Item
patients will be treated with thienopyridine oral bolus, either as a pre-treatment or immediately after stenting, and recommended to be continued on daily.
boolean
C1120149 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,3])
C3539076 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C2348535 (UMLS CUI [3,2])
Anticoagulation Therapy | Intravenous heparin | Bivalirudin Injection
Item
patients will be anticoagulated with intravenous heparin or bilvalirudin during the procedure and stopped immediately after completion of the procedure.
boolean
C0003281 (UMLS CUI [1])
C0354566 (UMLS CUI [2])
C4034102 (UMLS CUI [3])
Arterial Access Site Femoral artery | Catheter sheath Size | Incision of artery Site | Appropriateness Hemostatic Catheter Closure | TIMI Flow Grade | Left ventricular ejection fraction
Item
arterial access via the femoral artery (sheath 5, 6, 7 or 8 french) and an arteriotomy site suitable for hemostatic device closure. suitability for closure, defined as at least 5 mm from a bifurcation, puncture must not include the artery femoralis profunda or the superficial femoral artery, timi iii coronary flow upon completion of the intervention and left ventricular ejection fraction (lvef) less than 40 per cent.
boolean
C3272298 (UMLS CUI [1,1])
C0015801 (UMLS CUI [1,2])
C1299426 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0189583 (UMLS CUI [3,1])
C1515974 (UMLS CUI [3,2])
C0814634 (UMLS CUI [4,1])
C0179761 (UMLS CUI [4,2])
C0185003 (UMLS CUI [4,3])
C3272266 (UMLS CUI [5,1])
C4263591 (UMLS CUI [5,2])
C0428772 (UMLS CUI [6])
Residence Near Hospital
Item
patients who live less than an hour away from the hospital.
boolean
C0237096 (UMLS CUI [1,1])
C1706276 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Age
Item
age less than 30 years old or greater than 80 years old
boolean
C0001779 (UMLS CUI [1])
ST segment elevation myocardial infarction
Item
acute stemi
boolean
C1536220 (UMLS CUI [1])
Non-ST Elevated Myocardial Infarction | Troponin measurement
Item
non-stemi with documented troponin greater than 10 at presentation to the catheterization laboratory
boolean
C4255010 (UMLS CUI [1])
C0523952 (UMLS CUI [2])
Shock, Cardiogenic | Hemodynamic instability
Item
cardiogenic shock or hemodynamic instability
boolean
C0036980 (UMLS CUI [1])
C0948268 (UMLS CUI [2])
Heart valve disease Severe
Item
severe valvular heart disease
boolean
C0018824 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Medical contraindication Anticoagulation Therapy
Item
any contraindication to anticoagulation
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Bleeding tendency | Thrombocytopenia | Platelet Count measurement | Thrombasthenia | von Willebrand Disease | Anemia | Hemoglobin measurement | Hematocrit level | Blood Coagulation Disorder
Item
patients with bleeding diathesis (including thrombocytopenia (platelets less than 100,000), thrombasthenia, von willebrand's disease, or anemia (hgb less than 10 mg per dl, hct less than 30) or coagulopathy
boolean
C1458140 (UMLS CUI [1])
C0040034 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0040015 (UMLS CUI [4])
C0042974 (UMLS CUI [5])
C0002871 (UMLS CUI [6])
C0518015 (UMLS CUI [7])
C0518014 (UMLS CUI [8])
C0005779 (UMLS CUI [9])
Creatinine measurement, serum
Item
patients with a creatinine greater than 1.5 mg/ml
boolean
C0201976 (UMLS CUI [1])
International Normalized Ratio
Item
patients with an inr greater than 1.5
boolean
C0525032 (UMLS CUI [1])
Malignant Neoplasms | Autoimmune Disease
Item
patients with cancer or autoimmune disease
boolean
C0006826 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
Residence Remote Hospital
Item
patients who live greater than 60 minutes away from the hospital
boolean
C0237096 (UMLS CUI [1,1])
C0205157 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,3])
Follow-up Unable
Item
patients who will not be able to follow-up
boolean
C3274571 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Social support Inadequate | Support at home Inadequate | Homeless | Living Alone
Item
patients with inadequate social or home support (homeless, lives alone, etc)
boolean
C0037438 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C3161503 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0237154 (UMLS CUI [3])
C0439044 (UMLS CUI [4])
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