ID

43012

Description

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

Link

https://clinicaltrials.gov/show/NCT00293852

Keywords

Versions (2)
  1. 4/12/17 4/12/17 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure, Congestive NCT00293852

English

Eligibility Heart Failure, Congestive NCT00293852

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Heart failure

Data type

boolean

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

Age

Data type

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)
Description

Hospital admission: Primary diagnosis of heart failure

Data type

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):
Description

Modified framingham criteria

Data type

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
Description

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

Data type

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
Description

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

Data type

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):
Description

Metabolic syndrome

Data type

boolean

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

Waist

Data type

boolean

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

Blood pressure

Data type

boolean

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

Triglycerides

Data type

boolean

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

Fasting glucose measurement or diabetes mellitus

Data type

boolean

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

HDL measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428472
Exclusion Criteria
Description

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:
Description

No heart failure, metabolic syndrome, acute heart failure exacerbation

Data type

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.)
Description

Life expectancy

Data type

boolean

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

Affecting comorbidity

Data type

boolean

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

Informed consent

Data type

boolean

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

Mental incapacity

Data type

boolean

Alias
UMLS CUI [1]
C2229018
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Similar models

Eligibility Heart Failure, Congestive NCT00293852

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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