ID

20491

Description

Rapamycin-Eluting Stents With Different Polymer Coating to Reduce Restenosis (ISAR-TEST-3); ODM derived from: https://clinicaltrials.gov/show/NCT00350454

Lien

https://clinicaltrials.gov/show/NCT00350454

Mots-clés

Versions (1)
  1. 26/02/2017 26/02/2017 -
Téléchargé le

26 février 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Coronary Heart Disease NCT00350454

Anglais

Eligibility Coronary Heart Disease NCT00350454

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50% de novo stenosis located in native coronary vessels.
Description

Age | Symptoms Ischemic | Myocardial Ischemia Evidence of | Stenosis de novo Coronary Vessels

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0475224
UMLS CUI [3,1]
C0151744
UMLS CUI [3,2]
C0332120
UMLS CUI [4,1]
C1261287
UMLS CUI [4,2]
C1515568
UMLS CUI [4,3]
C0010075
written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
Description

Informed Consent | Informed Consent Patient Representatives

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
target lesion located in the left main trunk or bypass graft.
Description

Target Lesion Identification Left coronary artery main stem | Bypass graft

Type de données

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0226031
UMLS CUI [2]
C0185098
in-stent restenosis.
Description

In-stent coronary artery restenosis

Type de données

boolean

Alias
UMLS CUI [1]
C1868718
cardiogenic shock.
Description

Shock, Cardiogenic

Type de données

boolean

Alias
UMLS CUI [1]
C0036980
malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
Description

Malignant Neoplasms | Comorbidity Protocol Compliance Unable | Liver disease Severe | Kidney Disease Severe | Pancreatic Disease Severe | Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0022658
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0030286
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0023671
known allergy to the study medications: aspirin, clopidogrel, rapamycin, stainless steel.
Description

Hypersensitivity Investigational New Drugs | Aspirin allergy | Hypersensitivity clopidogrel | Hypersensitivity Sirolimus | Hypersensitivity Stainless Steel

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2]
C0004058
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0070166
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0072980
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0038126
pregnancy (present, suspected or planned) or positive pregnancy test.
Description

Pregnancy | Pregnancy Suspected | Pregnancy, Planned | Pregnancy test positive

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0032992
UMLS CUI [4]
C0240802
previous enrollment in this trial.
Description

Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
patient's inability to fully cooperate with the study protocol.
Description

Protocol Compliance Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Coronary Heart Disease NCT00350454

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age | Symptoms Ischemic | Myocardial Ischemia Evidence of | Stenosis de novo Coronary Vessels
Item
patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50% de novo stenosis located in native coronary vessels.
boolean
C0001779 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0475224 (UMLS CUI [2,2])
C0151744 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
C1261287 (UMLS CUI [4,1])
C1515568 (UMLS CUI [4,2])
C0010075 (UMLS CUI [4,3])
Informed Consent | Informed Consent Patient Representatives
Item
written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Target Lesion Identification Left coronary artery main stem | Bypass graft
Item
target lesion located in the left main trunk or bypass graft.
boolean
C2986546 (UMLS CUI [1,1])
C0226031 (UMLS CUI [1,2])
C0185098 (UMLS CUI [2])
In-stent coronary artery restenosis
Item
in-stent restenosis.
boolean
C1868718 (UMLS CUI [1])
Shock, Cardiogenic
Item
cardiogenic shock.
boolean
C0036980 (UMLS CUI [1])
Malignant Neoplasms | Comorbidity Protocol Compliance Unable | Liver disease Severe | Kidney Disease Severe | Pancreatic Disease Severe | Life Expectancy
Item
malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
boolean
C0006826 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0023895 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0022658 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0030286 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0023671 (UMLS CUI [6])
Hypersensitivity Investigational New Drugs | Aspirin allergy | Hypersensitivity clopidogrel | Hypersensitivity Sirolimus | Hypersensitivity Stainless Steel
Item
known allergy to the study medications: aspirin, clopidogrel, rapamycin, stainless steel.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0004058 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0072980 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0038126 (UMLS CUI [5,2])
Pregnancy | Pregnancy Suspected | Pregnancy, Planned | Pregnancy test positive
Item
pregnancy (present, suspected or planned) or positive pregnancy test.
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3])
C0240802 (UMLS CUI [4])
Study Subject Participation Status
Item
previous enrollment in this trial.
boolean
C2348568 (UMLS CUI [1])
Protocol Compliance Unable
Item
patient's inability to fully cooperate with the study protocol.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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