ID

16510

Description

Rapamycin+Estradiol- vs. Rapamycin-Eluting Stents to Reduce Restenosis (ISAR-PEACE); ODM derived from: https://clinicaltrials.gov/show/NCT00402636

Link

https://clinicaltrials.gov/show/NCT00402636

Keywords

Versions (2)
  1. 7/17/16 7/17/16 -
  2. 7/21/16 7/21/16 - Julian Varghese
Uploaded on

July 21, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Heart Disease NCT00402636

English

Eligibility Coronary Heart Disease NCT00402636

1 forms  
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, ischemic symptoms or evidence of myocardial ischemia, coronary vessel stenosis

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0151744
UMLS CUI [3]
C0242231
written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

target lesion located in the left main trunk or bypass graft

Data type

boolean

Alias
UMLS CUI [1,1]
C2184261
UMLS CUI [1,2]
C0226069
UMLS CUI [2,1]
C2184261
UMLS CUI [2,2]
C0185098
in-stent restenosis.
Description

In-stent restenosis

Data type

boolean

Alias
UMLS CUI [1]
C3272317
acute st-elevation myocardial infarction.
Description

acute st-elevation myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C1303258
cardiogenic shock.
Description

Cardiogenic shock

Data type

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

Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
known allergy to the study medications: aspirin, clopidogrel, rapamycin, estradiol, stainless steel.
Description

Allergy to the study medications

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0072980
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0014912
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0038126
pregnancy (present, suspected or planned) or positive pregnancy test.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
previous enrollment in this trial.
Description

Previous enrollment in this trial

Data type

boolean

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

inability to cooperate with the study protocol

Data type

boolean

Alias
UMLS CUI [1]
C0525058
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Similar models

Eligibility Coronary Heart Disease NCT00402636

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age, ischemic symptoms or evidence of myocardial ischemia, coronary vessel stenosis
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])
C0151744 (UMLS CUI [2])
C0242231 (UMLS CUI [3])
informed consent
Item
written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
target lesion located in the left main trunk or bypass graft
Item
target lesion located in the left main trunk or bypass graft.
boolean
C2184261 (UMLS CUI [1,1])
C0226069 (UMLS CUI [1,2])
C2184261 (UMLS CUI [2,1])
C0185098 (UMLS CUI [2,2])
In-stent restenosis
Item
in-stent restenosis.
boolean
C3272317 (UMLS CUI [1])
acute st-elevation myocardial infarction
Item
acute st-elevation myocardial infarction.
boolean
C1303258 (UMLS CUI [1])
Cardiogenic shock
Item
cardiogenic shock.
boolean
C0036980 (UMLS CUI [1])
Comorbidity
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
C0009488 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Allergy to the study medications
Item
known allergy to the study medications: aspirin, clopidogrel, rapamycin, estradiol, stainless steel.
boolean
C0020517 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0072980 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0014912 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0038126 (UMLS CUI [5,2])
Pregnancy
Item
pregnancy (present, suspected or planned) or positive pregnancy test.
boolean
C0032961 (UMLS CUI [1])
Previous enrollment in this trial
Item
previous enrollment in this trial.
boolean
C2348568 (UMLS CUI [1])
inability to cooperate with the study protocol
Item
patient's inability to fully cooperate with the study protocol.
boolean
C0525058 (UMLS CUI [1])
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