ID

20491

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00350454

Trefwoorden

Versies (1)
  1. 26-02-17 26-02-17 -
Geüploaded op

26 februari 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Coronary Heart Disease NCT00350454

Engels

Eligibility Coronary Heart Disease NCT00350454

1 Formulieren  
Inclusion Criteria
Beschrijving

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.
Beschrijving

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

Datatype

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.
Beschrijving

Informed Consent | Informed Consent Patient Representatives

Datatype

boolean

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

Exclusion Criteria

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

Target Lesion Identification Left coronary artery main stem | Bypass graft

Datatype

boolean

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

In-stent coronary artery restenosis

Datatype

boolean

Alias
UMLS CUI [1]
C1868718
cardiogenic shock.
Beschrijving

Shock, Cardiogenic

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Study Subject Participation Status

Datatype

boolean

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

Protocol Compliance Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
Terug naar het begin van de pagina

Similar models

Eligibility Coronary Heart Disease NCT00350454

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial