ID

43012

Beschrijving

Collaborative Care for Heart Failure Patients With the Metabolic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT00293852

Link

https://clinicaltrials.gov/show/NCT00293852

Trefwoorden

Versies (2)
  1. 12-04-17 12-04-17 -
  2. 17-09-21 17-09-21 -
Geüploaded op

17 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Heart Failure, Congestive NCT00293852

Engels

Eligibility Heart Failure, Congestive NCT00293852

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
individuals with heart failure of ischemic or non-ischemic etiologies
Beschrijving

Heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
age ≥18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
admitted to the hospital with a primary diagnosis of heart failure (need not be their first admission for heart failure)
Beschrijving

Hospital admission: Primary diagnosis of heart failure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0332137
UMLS CUI [1,3]
C0184666
meets the modified framingham criteria for the diagnosis of heart failure (2 major or 1 major / 2 minor are required):
Beschrijving

Modified framingham criteria

Datatype

boolean

Alias
UMLS CUI [1]
C3174416
major: paroxysmal nocturnal dyspnea (sudden shortness of breath at night), orthopnea (shortness of breath when supine), elevated jugular venous pressure, rales, the presence of an s3 heart sound, cardiomegaly on chest x-ray, pulmonary edema on chest x-ray
Beschrijving

Paroxysmal nocturnal dyspnea, orthopnea, elevated jugular venous pressure, s3 heart sound, cardiomegaly, pulmonary edema

Datatype

boolean

Alias
UMLS CUI [1]
C1956415
UMLS CUI [2]
C0085619
UMLS CUI [3]
C0520861
UMLS CUI [4]
C0232237
UMLS CUI [5]
C0018800
UMLS CUI [6]
C0034063
minor: lower extremity edema, night cough, dyspnea on exertion, hepatomegaly, pleural effusion on chest x-ray, heart rate > 120 bpm, weight loss > 10 pounds in 5 days while in hospital
Beschrijving

Lower extremity edema, night cough, dyspnea on exertion, hepatomegaly, pleural effusion, heart rate, weight loss

Datatype

boolean

Alias
UMLS CUI [1]
C0745830
UMLS CUI [2]
C0231912
UMLS CUI [3]
C0231807
UMLS CUI [4]
C0019209
UMLS CUI [5]
C0032227
UMLS CUI [6]
C0018810
UMLS CUI [7]
C1262477
• meets the national cholesterol education panel criteria for the metabolic syndrome (3 of 5 criteria must be present):
Beschrijving

Metabolic syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0524620
waist > 40 in for men, 35 in for women
Beschrijving

Waist

Datatype

boolean

Alias
UMLS CUI [1]
C0455829
blood pressure ≥ 130/85 mmhg or hypertension
Beschrijving

Blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0005823
triglycerides ≥150 mg/dl
Beschrijving

Triglycerides

Datatype

boolean

Alias
UMLS CUI [1]
C0202236
fasting glucose ≥ 100 mg/dl or diabetes
Beschrijving

Fasting glucose measurement or diabetes mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0202045
UMLS CUI [2]
C0011849
high density lipoprotein level (hdl) < 40 mg/dl for men, <50 for women
Beschrijving

HDL measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0428472
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will be excluded if they do not meet the definitions for heart failure and the metabolic syndrome listed above. also, heart failure patients admitted for a diagnosis other than acute heart failure exacerbation will not be included. other exclusion criteria include:
Beschrijving

No heart failure, metabolic syndrome, acute heart failure exacerbation

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518422
UMLS CUI [1,2]
C0018801
UMLS CUI [2,1]
C1518422
UMLS CUI [2,2]
C0524620
UMLS CUI [3,1]
C1518422
UMLS CUI [3,2]
C0742743
a condition, other than heart failure, that limits a patient's survival (such as cancer, active hepatitis, advanced hiv infection etc.)
Beschrijving

Life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
factors that may limit adherence to interventions or affect conduct of the trial
Beschrijving

Affecting comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
unable or unwilling to given informed consent
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
mental incapacity that limits patient's ability to live independently and benefit from patient education
Beschrijving

Mental incapacity

Datatype

boolean

Alias
UMLS CUI [1]
C2229018
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Similar models

Eligibility Heart Failure, Congestive NCT00293852

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure
Item
individuals with heart failure of ischemic or non-ischemic etiologies
boolean
C0018801 (UMLS CUI [1])
Age
Item
age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Hospital admission: Primary diagnosis of heart failure
Item
admitted to the hospital with a primary diagnosis of heart failure (need not be their first admission for heart failure)
boolean
C0018801 (UMLS CUI [1,1])
C0332137 (UMLS CUI [1,2])
C0184666 (UMLS CUI [1,3])
Modified framingham criteria
Item
meets the modified framingham criteria for the diagnosis of heart failure (2 major or 1 major / 2 minor are required):
boolean
C3174416 (UMLS CUI [1])
Paroxysmal nocturnal dyspnea, orthopnea, elevated jugular venous pressure, s3 heart sound, cardiomegaly, pulmonary edema
Item
major: paroxysmal nocturnal dyspnea (sudden shortness of breath at night), orthopnea (shortness of breath when supine), elevated jugular venous pressure, rales, the presence of an s3 heart sound, cardiomegaly on chest x-ray, pulmonary edema on chest x-ray
boolean
C1956415 (UMLS CUI [1])
C0085619 (UMLS CUI [2])
C0520861 (UMLS CUI [3])
C0232237 (UMLS CUI [4])
C0018800 (UMLS CUI [5])
C0034063 (UMLS CUI [6])
Lower extremity edema, night cough, dyspnea on exertion, hepatomegaly, pleural effusion, heart rate, weight loss
Item
minor: lower extremity edema, night cough, dyspnea on exertion, hepatomegaly, pleural effusion on chest x-ray, heart rate > 120 bpm, weight loss > 10 pounds in 5 days while in hospital
boolean
C0745830 (UMLS CUI [1])
C0231912 (UMLS CUI [2])
C0231807 (UMLS CUI [3])
C0019209 (UMLS CUI [4])
C0032227 (UMLS CUI [5])
C0018810 (UMLS CUI [6])
C1262477 (UMLS CUI [7])
Metabolic syndrome
Item
• meets the national cholesterol education panel criteria for the metabolic syndrome (3 of 5 criteria must be present):
boolean
C0524620 (UMLS CUI [1])
Waist
Item
waist > 40 in for men, 35 in for women
boolean
C0455829 (UMLS CUI [1])
Blood pressure
Item
blood pressure ≥ 130/85 mmhg or hypertension
boolean
C0005823 (UMLS CUI [1])
Triglycerides
Item
triglycerides ≥150 mg/dl
boolean
C0202236 (UMLS CUI [1])
Fasting glucose measurement or diabetes mellitus
Item
fasting glucose ≥ 100 mg/dl or diabetes
boolean
C0202045 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
HDL measurement
Item
high density lipoprotein level (hdl) < 40 mg/dl for men, <50 for women
boolean
C0428472 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
No heart failure, metabolic syndrome, acute heart failure exacerbation
Item
patients will be excluded if they do not meet the definitions for heart failure and the metabolic syndrome listed above. also, heart failure patients admitted for a diagnosis other than acute heart failure exacerbation will not be included. other exclusion criteria include:
boolean
C1518422 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C1518422 (UMLS CUI [2,1])
C0524620 (UMLS CUI [2,2])
C1518422 (UMLS CUI [3,1])
C0742743 (UMLS CUI [3,2])
Life expectancy
Item
a condition, other than heart failure, that limits a patient's survival (such as cancer, active hepatitis, advanced hiv infection etc.)
boolean
C0023671 (UMLS CUI [1])
Affecting comorbidity
Item
factors that may limit adherence to interventions or affect conduct of the trial
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
Informed consent
Item
unable or unwilling to given informed consent
boolean
C0021430 (UMLS CUI [1])
Mental incapacity
Item
mental incapacity that limits patient's ability to live independently and benefit from patient education
boolean
C2229018 (UMLS CUI [1])
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