ID

15991

Description

Endothelial Dysfunction Evaluation for Coronary Heart Disease Risk Estimation in Rheumatoid Arthritis (EDRA Study); ODM derived from: https://clinicaltrials.gov/show/NCT02341066

Link

https://clinicaltrials.gov/show/NCT02341066

Keywords

Versions (3)
  1. 6/21/16 6/21/16 -
  2. 6/21/16 6/21/16 -
  3. 6/24/16 6/24/16 -
Uploaded on

June 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02341066

English

Eligibility Rheumatoid Arthritis NCT02341066

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ra as defined by american college of rheumatology/european league against rheumatisms 2010 ra classification criteria
Description

Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
in the opinion of investigators, patients must be able to adhere to the study visit schedule and must be capable of giving informed consent
Description

Compliance behavior Study Protocol | Informed Consent

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous cardiovascular or cerebrovascular events (acute coronary syndrome, stable angina, stroke, interventional procedures, carotid endarterectomy, symptomatic peripheral artery ischemia)
Description

Cardiovascular event Previous | Event Cerebrovascular Previous | Acute Coronary Syndrome | Stable angina | Cerebrovascular accident | Interventional procedure | Carotid Endarterectomy | Peripheral arterial ischemia Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C1880018
UMLS CUI [2,3]
C0205156
UMLS CUI [3]
C0948089
UMLS CUI [4]
C0340288
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0184661
UMLS CUI [7]
C0014099
UMLS CUI [8,1]
C3888991
UMLS CUI [8,2]
C0231220
pathological ecg at rest
Description

Electrocardiogram abnormal At rest

Data type

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0443144
sign or symptoms of autonomous nervous system dysfunction
Description

Dysfunction of the autonomic nervous system Sign or Symptom

Data type

boolean

Alias
UMLS CUI [1,1]
C3277919
UMLS CUI [1,2]
C3540840
serious infections in the previous 6 months
Description

Communicable Diseases Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
concomitant severe illness: overt hepatic insufficiency; end stage renal disease (glomerular filtration rate <30 ml/h at cockrofts-gault formula); recent diagnosis of cancer
Description

Comorbidity Severe | Hepatic Insufficiency | End stage renal disease | Glomerular Filtration Rate Cockcroft-Gault formula | cancer diagnosis Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1306571
UMLS CUI [3]
C0022661
UMLS CUI [4,1]
C0017654
UMLS CUI [4,2]
C2924627
UMLS CUI [5,1]
C0920688
UMLS CUI [5,2]
C0332185
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
plans to leave target areas of each study site within three years
Description

Target area Change Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0017446
UMLS CUI [1,3]
C0392747
UMLS CUI [1,4]
C1301732
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Similar models

Eligibility Rheumatoid Arthritis NCT02341066

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
ra as defined by american college of rheumatology/european league against rheumatisms 2010 ra classification criteria
boolean
C0003873 (UMLS CUI [1])
Compliance behavior Study Protocol | Informed Consent
Item
in the opinion of investigators, patients must be able to adhere to the study visit schedule and must be capable of giving informed consent
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Cardiovascular event Previous | Event Cerebrovascular Previous | Acute Coronary Syndrome | Stable angina | Cerebrovascular accident | Interventional procedure | Carotid Endarterectomy | Peripheral arterial ischemia Symptomatic
Item
previous cardiovascular or cerebrovascular events (acute coronary syndrome, stable angina, stroke, interventional procedures, carotid endarterectomy, symptomatic peripheral artery ischemia)
boolean
C1320716 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0441471 (UMLS CUI [2,1])
C1880018 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0948089 (UMLS CUI [3])
C0340288 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0184661 (UMLS CUI [6])
C0014099 (UMLS CUI [7])
C3888991 (UMLS CUI [8,1])
C0231220 (UMLS CUI [8,2])
Electrocardiogram abnormal At rest
Item
pathological ecg at rest
boolean
C0522055 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
Dysfunction of the autonomic nervous system Sign or Symptom
Item
sign or symptoms of autonomous nervous system dysfunction
boolean
C3277919 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
Communicable Diseases Serious
Item
serious infections in the previous 6 months
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Comorbidity Severe | Hepatic Insufficiency | End stage renal disease | Glomerular Filtration Rate Cockcroft-Gault formula | cancer diagnosis Recent
Item
concomitant severe illness: overt hepatic insufficiency; end stage renal disease (glomerular filtration rate <30 ml/h at cockrofts-gault formula); recent diagnosis of cancer
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1306571 (UMLS CUI [2])
C0022661 (UMLS CUI [3])
C0017654 (UMLS CUI [4,1])
C2924627 (UMLS CUI [4,2])
C0920688 (UMLS CUI [5,1])
C0332185 (UMLS CUI [5,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Target area Change Planned
Item
plans to leave target areas of each study site within three years
boolean
C1521840 (UMLS CUI [1,1])
C0017446 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
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