ID

44638

Description

Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation; ODM derived from: https://clinicaltrials.gov/show/NCT02378064

Link

https://clinicaltrials.gov/show/NCT02378064

Keywords

Versions (2)
  1. 5/27/16 5/27/16 -
  2. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Inflammation Plaque, Atherosclerotic NCT02378064

English

Eligibility Inflammation Plaque, Atherosclerotic NCT02378064

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women at least 18 years of age inclusive
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with acute coronary syndromes or unstable angina pectoris
Description

Acute Coronary Syndrome | Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0002965
hypertension or blood pressure more than 140/90mmhg
Description

Hypertensive disease | Blood Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0005823
fdg pet/ct shows at least 1 hot uptakes at carotid and or ascending aorta
Description

FDG-Positron Emission Tomography | Fluorodeoxyglucose F18 X-Ray Computed Tomography | Uptake measurement | Carotid | Ascending aorta

Data type

boolean

Alias
UMLS CUI [1]
C3641247
UMLS CUI [2,1]
C0046056
UMLS CUI [2,2]
C0040405
UMLS CUI [3]
C0201807
UMLS CUI [4]
C0007272
UMLS CUI [5]
C1269009
the patient or guardian agrees to the study protocol and the schedule of clinical and fdg pet/ct follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site.
Description

Informed Consent Institutional Review Board Approval | Compliance behavior Study Protocol follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2346499
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C1522577
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients treated with carotid endarterectomy or stent placement
Description

Carotid Endarterectomy | Placement of stent

Data type

boolean

Alias
UMLS CUI [1]
C0014099
UMLS CUI [2]
C0522776
chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
Description

Chronic disease Requirement Therapeutic procedure | Adrenal Cortex Hormones | Intravenous steroid injection | Adrenal Cortex Hormones Intraarticular | Topical steroids | Inhaled steroids | Adrenal Cortex Hormones Nasal

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0563322
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C1522204
UMLS CUI [5]
C2064827
UMLS CUI [6]
C2065041
UMLS CUI [7,1]
C0001617
UMLS CUI [7,2]
C1522019
untreated hyperthyroidism, or hypothyroidism
Description

Hyperthyroidism untreated | Hypothyroidism

Data type

boolean

Alias
UMLS CUI [1,1]
C0020550
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0020676
any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study.
Description

Abnormality Compliance behavior Limited | Physical Examination | Laboratory Procedures | Electrocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0022885
UMLS CUI [4]
C1623258
evidence of congestive heart failure, or left ventricular ejection fraction < 40%.
Description

Congestive heart failure | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0428772
significant renal disease manifested by serum creatinine > 2.0mg/dl, or creatinine clearance of < 40 ml/min (by cockcroft-gault method).
Description

Kidney Diseases | Creatinine measurement, serum | Creatinine renal clearance Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0201976
UMLS CUI [3]
C1507751
hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alt or ast > 3 times upper limit of normal).
Description

Liver diseases | Obstruction of biliary tree | Elevated liver enzymes | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0400979
UMLS CUI [3]
C0235996
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201899
history of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s).
Description

Asthma Adult | Bronchial Spasm | Anti-Asthmatic Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0001675
UMLS CUI [2]
C0006266
UMLS CUI [3]
C0282556
unwillingness or inability to comply with the procedures described in this protocol.
Description

Study Protocol Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
patient's pregnant or breast-feeding or child-bearing potential.
Description

Pregnancy | Breast Feeding | Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
type i diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
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Similar models

Eligibility Inflammation Plaque, Atherosclerotic NCT02378064

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men or women at least 18 years of age inclusive
boolean
C0001779 (UMLS CUI [1])
Acute Coronary Syndrome | Angina, Unstable
Item
patients with acute coronary syndromes or unstable angina pectoris
boolean
C0948089 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Hypertensive disease | Blood Pressure
Item
hypertension or blood pressure more than 140/90mmhg
boolean
C0020538 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
FDG-Positron Emission Tomography | Fluorodeoxyglucose F18 X-Ray Computed Tomography | Uptake measurement | Carotid | Ascending aorta
Item
fdg pet/ct shows at least 1 hot uptakes at carotid and or ascending aorta
boolean
C3641247 (UMLS CUI [1])
C0046056 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0201807 (UMLS CUI [3])
C0007272 (UMLS CUI [4])
C1269009 (UMLS CUI [5])
Informed Consent Institutional Review Board Approval | Compliance behavior Study Protocol follow-up
Item
the patient or guardian agrees to the study protocol and the schedule of clinical and fdg pet/ct follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site.
boolean
C0021430 (UMLS CUI [1,1])
C2346499 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C1522577 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Carotid Endarterectomy | Placement of stent
Item
patients treated with carotid endarterectomy or stent placement
boolean
C0014099 (UMLS CUI [1])
C0522776 (UMLS CUI [2])
Chronic disease Requirement Therapeutic procedure | Adrenal Cortex Hormones | Intravenous steroid injection | Adrenal Cortex Hormones Intraarticular | Topical steroids | Inhaled steroids | Adrenal Cortex Hormones Nasal
Item
chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
boolean
C0008679 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2])
C0563322 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C1522204 (UMLS CUI [4,2])
C2064827 (UMLS CUI [5])
C2065041 (UMLS CUI [6])
C0001617 (UMLS CUI [7,1])
C1522019 (UMLS CUI [7,2])
Hyperthyroidism untreated | Hypothyroidism
Item
untreated hyperthyroidism, or hypothyroidism
boolean
C0020550 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0020676 (UMLS CUI [2])
Abnormality Compliance behavior Limited | Physical Examination | Laboratory Procedures | Electrocardiography
Item
any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study.
boolean
C1704258 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0031809 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
C1623258 (UMLS CUI [4])
Congestive heart failure | Left ventricular ejection fraction
Item
evidence of congestive heart failure, or left ventricular ejection fraction < 40%.
boolean
C0018802 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Kidney Diseases | Creatinine measurement, serum | Creatinine renal clearance Cockcroft-Gault formula
Item
significant renal disease manifested by serum creatinine > 2.0mg/dl, or creatinine clearance of < 40 ml/min (by cockcroft-gault method).
boolean
C0022658 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1507751 (UMLS CUI [3])
Liver diseases | Obstruction of biliary tree | Elevated liver enzymes | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alt or ast > 3 times upper limit of normal).
boolean
C0023895 (UMLS CUI [1])
C0400979 (UMLS CUI [2])
C0235996 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
Asthma Adult | Bronchial Spasm | Anti-Asthmatic Agents
Item
history of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s).
boolean
C0004096 (UMLS CUI [1,1])
C0001675 (UMLS CUI [1,2])
C0006266 (UMLS CUI [2])
C0282556 (UMLS CUI [3])
Study Protocol Compliance behavior Limited
Item
unwillingness or inability to comply with the procedures described in this protocol.
boolean
C2348563 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Childbearing Potential
Item
patient's pregnant or breast-feeding or child-bearing potential.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent
Item
type i diabetes
boolean
C0011854 (UMLS CUI [1])
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