ID

20481

Description

RIAPRE - Non-interventional Registry of Anticoagulation Treatment (BI-006-IT); ODM derived from: https://clinicaltrials.gov/show/NCT00317343

Link

https://clinicaltrials.gov/show/NCT00317343

Keywords

Versions (1)
  1. 2/24/17 2/24/17 -
Uploaded on

February 24, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Disease NCT00317343

English

Eligibility Coronary Disease NCT00317343

1 forms  
Criteria
Description

Criteria

medical condition or disease to be studied: age > 18 years.
Description

Medical condition | Disease | Age

Data type

boolean

Alias
UMLS CUI [1]
C3843040
UMLS CUI [2]
C0012634
UMLS CUI [3]
C0001779
patients are candidates for a pci with a planned anticoagulation regime other than unfractionated heparin in monotherapy. taking into consideration the national and international guidelines for this area and the registered indications of the drugs currently used for this purpose it is predicted that the patients will probably receive one of the following:
Description

Indication Percutaneous Coronary Intervention | Anticoagulation Therapy Planned | Unfractionated Heparin

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1532338
UMLS CUI [2,1]
C0003281
UMLS CUI [2,2]
C1301732
UMLS CUI [3]
C2825026
unfractionated heparin as an intravenous (iv) bolus followed by iv bolus +
Description

Unfractionated Heparin Intravenous Bolus

Data type

boolean

Alias
UMLS CUI [1,1]
C2825026
UMLS CUI [1,2]
C1522229
infusion of a gpi (abciximab, tirofiban or eptifibatide); or
Description

infusion of GP IIB-IIIa inhibitor Intravenous Bolus | abciximab | tirofiban | eptifibatide

Data type

boolean

Alias
UMLS CUI [1,1]
C0864559
UMLS CUI [1,2]
C1522229
UMLS CUI [2]
C0288672
UMLS CUI [3]
C0247025
UMLS CUI [4]
C0253563
bivalirudin as an iv bolus followed by iv infusion, as per the pertinent summary of product characteristics (spcs).
Description

bivalirudin Intravenous Bolus | Intravenous infusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0168273
UMLS CUI [1,2]
C1522229
UMLS CUI [2]
C0021440
having provided an informed consent (to anonymous data treatment).
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
a planned anticoagulation regime means that any candidate patient should be identified on the basis of pre-procedural factors and requested to give his/her consent before the pci is initiated. patients receiving bail-out gpi for intraprocedural complications should not be considered for the inclusion. however, a pre-included patient could receive a bail-out gpi if deemed necessary.
Description

Anticoagulation Therapy Planned | Percutaneous Coronary Intervention | infusion of GP IIB-IIIa inhibitor Procedural complication

Data type

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C1532338
UMLS CUI [3,1]
C0864559
UMLS CUI [3,2]
C1141861
the allocation of any individual patient to the category of "high risk" elective pci will be made independently and autonomously by the caring physician. however, it is recommended to consider the suitability of patients on the basis of these indicative elements:
Description

Percutaneous Coronary Intervention elective High risk

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0439608
UMLS CUI [1,3]
C0332167
age > 75 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
known diabetes mellitus (type i or type ii).
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
known renal insufficiency, i.e. serum creatinine > 1.8 mg or glomerular filtration rate (gfr) > 60 ml/min (calculated with the cockroft formula).
Description

Renal Insufficiency | Creatinine measurement, serum | Glomerular Filtration Rate Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C0017654
UMLS CUI [3,2]
C2924627
multivessel or complex procedure.
Description

Interventional procedure Blood Vessel multiple | Complex procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C0439064
UMLS CUI [2]
C1292781
planned stent on a bifurcation.
Description

Planned Stent, Vascular, Coronary, Bifurcation

Data type

boolean

Alias
UMLS CUI [1,1]
C3856927
UMLS CUI [1,2]
C1301732
planned stent > 6 cm long.
Description

Length of stent Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0449462
UMLS CUI [1,2]
C1301732
pci on a degenerated venous bypass: in this particular case a distal protection device should always be used.
Description

Percutaneous Coronary Intervention Bypass Venous

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0741847
UMLS CUI [1,3]
C0348013
non st elevation acute coronary syndrome with a pci planned later than 72 hours after the diagnosis without clinical instability (= "cooled" non st elevation acute coronary syndrome). this type of patient is considered to be essentially stable and his/her level of risk can be comparable to the risk of patients who are candidates for elective pci with additional risk factors as listed above.
Description

Non ST segment elevation acute coronary syndrome | Percutaneous Coronary Intervention Planned | Patients Risk factors Additional

Data type

boolean

Alias
UMLS CUI [1]
C3160886
UMLS CUI [2,1]
C1532338
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0035648
UMLS CUI [3,3]
C1524062
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
there will be no specific exclusion criteria other than those listed in the summary of product characteristics of every individual agent.
Description

Exclusion Criteria Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205370
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Similar models

Eligibility Coronary Disease NCT00317343

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Medical condition | Disease | Age
Item
medical condition or disease to be studied: age > 18 years.
boolean
C3843040 (UMLS CUI [1])
C0012634 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Indication Percutaneous Coronary Intervention | Anticoagulation Therapy Planned | Unfractionated Heparin
Item
patients are candidates for a pci with a planned anticoagulation regime other than unfractionated heparin in monotherapy. taking into consideration the national and international guidelines for this area and the registered indications of the drugs currently used for this purpose it is predicted that the patients will probably receive one of the following:
boolean
C3146298 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0003281 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C2825026 (UMLS CUI [3])
Unfractionated Heparin Intravenous Bolus
Item
unfractionated heparin as an intravenous (iv) bolus followed by iv bolus +
boolean
C2825026 (UMLS CUI [1,1])
C1522229 (UMLS CUI [1,2])
infusion of GP IIB-IIIa inhibitor Intravenous Bolus | abciximab | tirofiban | eptifibatide
Item
infusion of a gpi (abciximab, tirofiban or eptifibatide); or
boolean
C0864559 (UMLS CUI [1,1])
C1522229 (UMLS CUI [1,2])
C0288672 (UMLS CUI [2])
C0247025 (UMLS CUI [3])
C0253563 (UMLS CUI [4])
bivalirudin Intravenous Bolus | Intravenous infusion
Item
bivalirudin as an iv bolus followed by iv infusion, as per the pertinent summary of product characteristics (spcs).
boolean
C0168273 (UMLS CUI [1,1])
C1522229 (UMLS CUI [1,2])
C0021440 (UMLS CUI [2])
Informed Consent
Item
having provided an informed consent (to anonymous data treatment).
boolean
C0021430 (UMLS CUI [1])
Anticoagulation Therapy Planned | Percutaneous Coronary Intervention | infusion of GP IIB-IIIa inhibitor Procedural complication
Item
a planned anticoagulation regime means that any candidate patient should be identified on the basis of pre-procedural factors and requested to give his/her consent before the pci is initiated. patients receiving bail-out gpi for intraprocedural complications should not be considered for the inclusion. however, a pre-included patient could receive a bail-out gpi if deemed necessary.
boolean
C0003281 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1532338 (UMLS CUI [2])
C0864559 (UMLS CUI [3,1])
C1141861 (UMLS CUI [3,2])
Percutaneous Coronary Intervention elective High risk
Item
the allocation of any individual patient to the category of "high risk" elective pci will be made independently and autonomously by the caring physician. however, it is recommended to consider the suitability of patients on the basis of these indicative elements:
boolean
C1532338 (UMLS CUI [1,1])
C0439608 (UMLS CUI [1,2])
C0332167 (UMLS CUI [1,3])
Age
Item
age > 75 years.
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
known diabetes mellitus (type i or type ii).
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Renal Insufficiency | Creatinine measurement, serum | Glomerular Filtration Rate Cockcroft-Gault formula
Item
known renal insufficiency, i.e. serum creatinine > 1.8 mg or glomerular filtration rate (gfr) > 60 ml/min (calculated with the cockroft formula).
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0017654 (UMLS CUI [3,1])
C2924627 (UMLS CUI [3,2])
Interventional procedure Blood Vessel multiple | Complex procedure
Item
multivessel or complex procedure.
boolean
C0184661 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
C1292781 (UMLS CUI [2])
Planned Stent, Vascular, Coronary, Bifurcation
Item
planned stent on a bifurcation.
boolean
C3856927 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Length of stent Planned
Item
planned stent > 6 cm long.
boolean
C0449462 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Percutaneous Coronary Intervention Bypass Venous
Item
pci on a degenerated venous bypass: in this particular case a distal protection device should always be used.
boolean
C1532338 (UMLS CUI [1,1])
C0741847 (UMLS CUI [1,2])
C0348013 (UMLS CUI [1,3])
Non ST segment elevation acute coronary syndrome | Percutaneous Coronary Intervention Planned | Patients Risk factors Additional
Item
non st elevation acute coronary syndrome with a pci planned later than 72 hours after the diagnosis without clinical instability (= "cooled" non st elevation acute coronary syndrome). this type of patient is considered to be essentially stable and his/her level of risk can be comparable to the risk of patients who are candidates for elective pci with additional risk factors as listed above.
boolean
C3160886 (UMLS CUI [1])
C1532338 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C0035648 (UMLS CUI [3,2])
C1524062 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Unspecified
Item
there will be no specific exclusion criteria other than those listed in the summary of product characteristics of every individual agent.
boolean
C0680251 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
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