ID

39498

Description

Carbohydrate Antigen 125-guided Therapy in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02008110

Link

https://clinicaltrials.gov/show/NCT02008110

Keywords

Versions (1)
  1. 1/19/20 1/19/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 19, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02008110

English

Eligibility Heart Failure NCT02008110

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
at least 1 admission for ahf, in the last 180 days.
Description

Admission Quantity Acute heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0264714
demonstrates functional new york heart association status of class ≥ii at the moment of enrollment.
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
objective evidence, either during the index admission or at least 180 days before enrollment, of a structural or functional abnormality of the heart at rest, and defined as: n terminal-pro-brain natriuretic peptide >1000 pg/ml or brain natriuretic peptide >100 pg/ml or echocardiographic abnormalities congruent with hf diagnosis such as: systolic left ventricular dysfunction (lvef <50%); left ventricular hypertrophy (defined as left ventricular septum or left ventricular posterior wall thickness ≥12 millimeters or left ventricular mass index >104 g/m2 in women or 116 g/m2 in men); ee`>15 or significant valvular heart disease (moderate-severe).
Description

Structural Heart Abnormality | Cardiac function Abnormality At rest | N-Terminal ProB-type Natriuretic Peptide Measurement | Brain natriuretic peptide measurement | Echocardiography Abnormality Congruent Heart failure | Left ventricular systolic dysfunction | Left ventricular ejection fraction | Left Ventricular Hypertrophy | Left Ventricular septum Thickness | Inferior wall of left ventricle Thickness | Mass index of left ventricle | Gender | Heart valve disease Moderate | Heart valve disease Severe

Data type

boolean

Alias
UMLS CUI [1]
C3274789
UMLS CUI [2,1]
C0232164
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0443144
UMLS CUI [3]
C3272900
UMLS CUI [4]
C1095989
UMLS CUI [5,1]
C0013516
UMLS CUI [5,2]
C1704258
UMLS CUI [5,3]
C0439853
UMLS CUI [5,4]
C0018801
UMLS CUI [6]
C1277187
UMLS CUI [7]
C0428772
UMLS CUI [8]
C0149721
UMLS CUI [9,1]
C0225870
UMLS CUI [9,2]
C0443246
UMLS CUI [9,3]
C1280412
UMLS CUI [10,1]
C0504056
UMLS CUI [10,2]
C1280412
UMLS CUI [11]
C2059474
UMLS CUI [12]
C0079399
UMLS CUI [13,1]
C0018824
UMLS CUI [13,2]
C0205081
UMLS CUI [14,1]
C0018824
UMLS CUI [14,2]
C0205082
a plasma ca125 value >35 u/ml in a recent test evaluation (at least 30 days before enrollment, and preferably assessed before hospital discharge).
Description

Increased plasma CA 125

Data type

boolean

Alias
UMLS CUI [1]
C4476918
patient must be capable of understanding and signing an informed consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
life expectancy <12 months due to other diseases different from hf.
Description

Life Expectancy Due to Disease | Exception Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0012634
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018801
having undergone a cardiac transplantation, coronary revascularization procedure (percutaneous coronary intervention and/or coronary artery bypass grafting) or cardiac valve replacement in the past 3 months.
Description

Heart Transplantation | Coronary revascularisation | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery | Heart valve replacement

Data type

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2]
C0877341
UMLS CUI [3]
C1532338
UMLS CUI [4]
C0010055
UMLS CUI [5]
C0190173
angina pectoris higher than class ii (canadian cardiovascular society classification).
Description

Angina Pectoris Canadian Cardiovascular Society classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C1277207
pregnancy at the moment of enrollment.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
valvular heart disease already scheduled for surgical intervention.
Description

Heart valve disease Scheduled Surgical intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205539
UMLS CUI [1,3]
C0549433
severe chronic obstructive and/or restrictive pulmonary disease, requiring continuous oxygen administration.
Description

Severe chronic obstructive pulmonary disease | Restrictive pulmonary disease severe chronic | Oxygen Therapy Continuous Required

Data type

boolean

Alias
UMLS CUI [1]
C0730607
UMLS CUI [2,1]
C0877013
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0205191
UMLS CUI [3,1]
C0184633
UMLS CUI [3,2]
C0549178
UMLS CUI [3,3]
C1514873
serum creatinine level > 3 mg/dl or chronic renal insufficiency on dialysis treatment.
Description

Creatinine measurement, serum | Chronic Kidney Insufficiency | Dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0403447
UMLS CUI [3]
C0011946
patients receiving resynchronization therapy during the index admission.
Description

Cardiac Resynchronization Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1167956
significant concurrent medical diseases including cancer or a history of cancer within 5 years of entering the screening period, endometriosis, cirrhosis, acute coronary syndrome within 6 months, uncontrolled hypertension, history of human immunodeficiency virus (hiv) infection, or a significant active infection.
Description

Comorbidity | Malignant Neoplasms | History of cancer | Endometriosis | Liver Cirrhosis | Acute Coronary Syndrome | Uncontrolled hypertension | HIV Infection | Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0455471
UMLS CUI [4]
C0014175
UMLS CUI [5]
C0023890
UMLS CUI [6]
C0948089
UMLS CUI [7]
C1868885
UMLS CUI [8]
C0019693
UMLS CUI [9]
C0009450
participating in another randomized study.
Description

Study Subject Participation Status | Clinical Trial, Randomized

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0206034
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Similar models

Eligibility Heart Failure NCT02008110

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Admission Quantity Acute heart failure
Item
at least 1 admission for ahf, in the last 180 days.
boolean
C0184666 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0264714 (UMLS CUI [1,3])
New York Heart Association Classification
Item
demonstrates functional new york heart association status of class ≥ii at the moment of enrollment.
boolean
C1275491 (UMLS CUI [1])
Structural Heart Abnormality | Cardiac function Abnormality At rest | N-Terminal ProB-type Natriuretic Peptide Measurement | Brain natriuretic peptide measurement | Echocardiography Abnormality Congruent Heart failure | Left ventricular systolic dysfunction | Left ventricular ejection fraction | Left Ventricular Hypertrophy | Left Ventricular septum Thickness | Inferior wall of left ventricle Thickness | Mass index of left ventricle | Gender | Heart valve disease Moderate | Heart valve disease Severe
Item
objective evidence, either during the index admission or at least 180 days before enrollment, of a structural or functional abnormality of the heart at rest, and defined as: n terminal-pro-brain natriuretic peptide >1000 pg/ml or brain natriuretic peptide >100 pg/ml or echocardiographic abnormalities congruent with hf diagnosis such as: systolic left ventricular dysfunction (lvef <50%); left ventricular hypertrophy (defined as left ventricular septum or left ventricular posterior wall thickness ≥12 millimeters or left ventricular mass index >104 g/m2 in women or 116 g/m2 in men); ee`>15 or significant valvular heart disease (moderate-severe).
boolean
C3274789 (UMLS CUI [1])
C0232164 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0443144 (UMLS CUI [2,3])
C3272900 (UMLS CUI [3])
C1095989 (UMLS CUI [4])
C0013516 (UMLS CUI [5,1])
C1704258 (UMLS CUI [5,2])
C0439853 (UMLS CUI [5,3])
C0018801 (UMLS CUI [5,4])
C1277187 (UMLS CUI [6])
C0428772 (UMLS CUI [7])
C0149721 (UMLS CUI [8])
C0225870 (UMLS CUI [9,1])
C0443246 (UMLS CUI [9,2])
C1280412 (UMLS CUI [9,3])
C0504056 (UMLS CUI [10,1])
C1280412 (UMLS CUI [10,2])
C2059474 (UMLS CUI [11])
C0079399 (UMLS CUI [12])
C0018824 (UMLS CUI [13,1])
C0205081 (UMLS CUI [13,2])
C0018824 (UMLS CUI [14,1])
C0205082 (UMLS CUI [14,2])
Increased plasma CA 125
Item
a plasma ca125 value >35 u/ml in a recent test evaluation (at least 30 days before enrollment, and preferably assessed before hospital discharge).
boolean
C4476918 (UMLS CUI [1])
Informed Consent
Item
patient must be capable of understanding and signing an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Life Expectancy Due to Disease | Exception Heart failure
Item
life expectancy <12 months due to other diseases different from hf.
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
Heart Transplantation | Coronary revascularisation | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery | Heart valve replacement
Item
having undergone a cardiac transplantation, coronary revascularization procedure (percutaneous coronary intervention and/or coronary artery bypass grafting) or cardiac valve replacement in the past 3 months.
boolean
C0018823 (UMLS CUI [1])
C0877341 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C0190173 (UMLS CUI [5])
Angina Pectoris Canadian Cardiovascular Society classification
Item
angina pectoris higher than class ii (canadian cardiovascular society classification).
boolean
C0002962 (UMLS CUI [1,1])
C1277207 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy at the moment of enrollment.
boolean
C0032961 (UMLS CUI [1])
Heart valve disease Scheduled Surgical intervention
Item
valvular heart disease already scheduled for surgical intervention.
boolean
C0018824 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0549433 (UMLS CUI [1,3])
Severe chronic obstructive pulmonary disease | Restrictive pulmonary disease severe chronic | Oxygen Therapy Continuous Required
Item
severe chronic obstructive and/or restrictive pulmonary disease, requiring continuous oxygen administration.
boolean
C0730607 (UMLS CUI [1])
C0877013 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0184633 (UMLS CUI [3,1])
C0549178 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
Creatinine measurement, serum | Chronic Kidney Insufficiency | Dialysis
Item
serum creatinine level > 3 mg/dl or chronic renal insufficiency on dialysis treatment.
boolean
C0201976 (UMLS CUI [1])
C0403447 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
Cardiac Resynchronization Therapy
Item
patients receiving resynchronization therapy during the index admission.
boolean
C1167956 (UMLS CUI [1])
Comorbidity | Malignant Neoplasms | History of cancer | Endometriosis | Liver Cirrhosis | Acute Coronary Syndrome | Uncontrolled hypertension | HIV Infection | Communicable Disease
Item
significant concurrent medical diseases including cancer or a history of cancer within 5 years of entering the screening period, endometriosis, cirrhosis, acute coronary syndrome within 6 months, uncontrolled hypertension, history of human immunodeficiency virus (hiv) infection, or a significant active infection.
boolean
C0009488 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0455471 (UMLS CUI [3])
C0014175 (UMLS CUI [4])
C0023890 (UMLS CUI [5])
C0948089 (UMLS CUI [6])
C1868885 (UMLS CUI [7])
C0019693 (UMLS CUI [8])
C0009450 (UMLS CUI [9])
Study Subject Participation Status | Clinical Trial, Randomized
Item
participating in another randomized study.
boolean
C2348568 (UMLS CUI [1])
C0206034 (UMLS CUI [2])
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