ID

20857

Descrição

Predicting Response to Cardiac Resynchronization Therapy in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00359372

Link

https://clinicaltrials.gov/show/NCT00359372

Palavras-chave

Versões (1)
  1. 22/03/2017 22/03/2017 -
Transferido a

22 de março de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00359372

Inglês

Eligibility Heart Failure NCT00359372

1 Formulários  
Criteria
Descrição

Criteria

no one will be excluded from this study based on race, gender, and ethnicity.
Descrição

Racial group Any | Gender Both | Ethnic group Any

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C1552551
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C1706086
UMLS CUI [3,1]
C0015031
UMLS CUI [3,2]
C1552551
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. lv dysfunction with an lv ejection fraction less than or equal to 35% (by clinical echocardiography, cardiac catheterization, radionuclide ventriculography, or mri).
Descrição

Ventricular Dysfunction, Left | Left ventricular ejection fraction | Echocardiography | Cardiac Catheterization Procedures | Radionuclide Ventriculography | Magnetic Resonance Imaging

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242698
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0013516
UMLS CUI [4]
C0018795
UMLS CUI [5]
C0034610
UMLS CUI [6]
C0024485
2. new york heart association (nyha) class iii or iv functional status
Descrição

New York Heart Association Classification Functional Status

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1275491
UMLS CUI [1,2]
C0598463
3. qrs interval greater than or equal to 120msec (measured on clinical ecg)
Descrição

electrocardiogram: QRS interval

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2168881
4. optimal pharmacological therapy for heart failure with at least 1 month on an ace-inhibitor or angiotensin ii receptor blocker (arb) and if on a beta blocker, 3 months on a stable dose of a beta blocker. patients need to be taking their medicines consistently to be enrolled in this study.
Descrição

Pharmacotherapy Optimal Heart failure | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists Dose Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C2698651
UMLS CUI [1,3]
C0018801
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0521942
UMLS CUI [4,1]
C0304516
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. coronary artery bypass graft surgery or percutaneous coronary intervention within 60 days of enrollment.
Descrição

Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2]
C1532338
2. chronic medically refractory atrial tachyarrhythmias
Descrição

Tachyarrhythmia Atrial chronic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0080203
UMLS CUI [1,2]
C0018792
UMLS CUI [1,3]
C0205191
3. history of medical non-compliance
Descrição

Patient Non-Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0376405
4. women who are pregnant or not using medically acceptable birth control (since the x-rays used to guide pacemaker therapy may increase the risk to the fetus and the fetal risks of gadolinium are not well known).
Descrição

Pregnancy Contraceptive methods Missing | Gadolinium Risk Fetal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1705492
UMLS CUI [2,1]
C0016911
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0521457
5. contraindication to mri scanning including patients with the following devices:
Descrição

Medical contraindication Magnetic Resonance Imaging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
i. central nervous system aneurysm clips
Descrição

Central Nervous System Aneurysm clip

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3714787
UMLS CUI [1,2]
C0179977
ii. implanted neural stimulator
Descrição

Neurostimulator Implanted

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0582124
UMLS CUI [1,2]
C0021102
iii. implanted cardiac pacemaker or defibrillator prior to enrollment
Descrição

implanted pacemaker | defibrillator implanted

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0848753
UMLS CUI [2]
C0850291
iv. cochlear implant
Descrição

Cochlear Implant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009199
v. ocular foreign body (e.g. metal shavings)
Descrição

Ocular Foreign Body

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3898107
vi. insulin pump
Descrição

Insulin pump

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1140609
vii. metal shrapnel or bullet
Descrição

Shrapnel | Bullet

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0522670
UMLS CUI [2]
C0336699
6. contraindications to mri contrast agent administration:
Descrição

Medical contraindication Magnetic resonance imaging contrast media

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0180108
i. lactating women
Descrição

Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006147
ii. patients with hemoglobinopathies
Descrição

Hemoglobinopathies

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019045
iii. severe renal disease (crcl less than 20 ml/min)
Descrição

Kidney Disease Severe | Creatinine clearance measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0373595
7. baseline 6-minute hall walk distance more than 450 meters (to exclude patients who are unlikely to truly have nyha class iii to iv heart failure)
Descrição

6-minute walk test Distance | Heart failure New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C0012751
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
8. enrollment in any concurrent study that may confound the results of this study
Descrição

Study Subject Participation Status Interferes with Research results

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
9. life expectancy less than 6 months because of other medical conditions.
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
10. age less than 18 years since this disease is not prevalent in children.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
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Similar models

Eligibility Heart Failure NCT00359372

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Racial group Any | Gender Both | Ethnic group Any
Item
no one will be excluded from this study based on race, gender, and ethnicity.
boolean
C0034510 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C1706086 (UMLS CUI [2,2])
C0015031 (UMLS CUI [3,1])
C1552551 (UMLS CUI [3,2])
Item Group
C1512693 (UMLS CUI)
Ventricular Dysfunction, Left | Left ventricular ejection fraction | Echocardiography | Cardiac Catheterization Procedures | Radionuclide Ventriculography | Magnetic Resonance Imaging
Item
1. lv dysfunction with an lv ejection fraction less than or equal to 35% (by clinical echocardiography, cardiac catheterization, radionuclide ventriculography, or mri).
boolean
C0242698 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C0013516 (UMLS CUI [3])
C0018795 (UMLS CUI [4])
C0034610 (UMLS CUI [5])
C0024485 (UMLS CUI [6])
New York Heart Association Classification Functional Status
Item
2. new york heart association (nyha) class iii or iv functional status
boolean
C1275491 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
electrocardiogram: QRS interval
Item
3. qrs interval greater than or equal to 120msec (measured on clinical ecg)
boolean
C2168881 (UMLS CUI [1])
Pharmacotherapy Optimal Heart failure | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists Dose Stable
Item
4. optimal pharmacological therapy for heart failure with at least 1 month on an ace-inhibitor or angiotensin ii receptor blocker (arb) and if on a beta blocker, 3 months on a stable dose of a beta blocker. patients need to be taking their medicines consistently to be enrolled in this study.
boolean
C0013216 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
C0304516 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
1. coronary artery bypass graft surgery or percutaneous coronary intervention within 60 days of enrollment.
boolean
C0010055 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
Tachyarrhythmia Atrial chronic
Item
2. chronic medically refractory atrial tachyarrhythmias
boolean
C0080203 (UMLS CUI [1,1])
C0018792 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
Patient Non-Compliance
Item
3. history of medical non-compliance
boolean
C0376405 (UMLS CUI [1])
Pregnancy Contraceptive methods Missing | Gadolinium Risk Fetal
Item
4. women who are pregnant or not using medically acceptable birth control (since the x-rays used to guide pacemaker therapy may increase the risk to the fetus and the fetal risks of gadolinium are not well known).
boolean
C0032961 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1705492 (UMLS CUI [1,3])
C0016911 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0521457 (UMLS CUI [2,3])
Medical contraindication Magnetic Resonance Imaging
Item
5. contraindication to mri scanning including patients with the following devices:
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Central Nervous System Aneurysm clip
Item
i. central nervous system aneurysm clips
boolean
C3714787 (UMLS CUI [1,1])
C0179977 (UMLS CUI [1,2])
Neurostimulator Implanted
Item
ii. implanted neural stimulator
boolean
C0582124 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
implanted pacemaker | defibrillator implanted
Item
iii. implanted cardiac pacemaker or defibrillator prior to enrollment
boolean
C0848753 (UMLS CUI [1])
C0850291 (UMLS CUI [2])
Cochlear Implant
Item
iv. cochlear implant
boolean
C0009199 (UMLS CUI [1])
Ocular Foreign Body
Item
v. ocular foreign body (e.g. metal shavings)
boolean
C3898107 (UMLS CUI [1])
Insulin pump
Item
vi. insulin pump
boolean
C1140609 (UMLS CUI [1])
Shrapnel | Bullet
Item
vii. metal shrapnel or bullet
boolean
C0522670 (UMLS CUI [1])
C0336699 (UMLS CUI [2])
Medical contraindication Magnetic resonance imaging contrast media
Item
6. contraindications to mri contrast agent administration:
boolean
C1301624 (UMLS CUI [1,1])
C0180108 (UMLS CUI [1,2])
Breast Feeding
Item
i. lactating women
boolean
C0006147 (UMLS CUI [1])
Hemoglobinopathies
Item
ii. patients with hemoglobinopathies
boolean
C0019045 (UMLS CUI [1])
Kidney Disease Severe | Creatinine clearance measurement
Item
iii. severe renal disease (crcl less than 20 ml/min)
boolean
C0022658 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
6-minute walk test Distance | Heart failure New York Heart Association Classification
Item
7. baseline 6-minute hall walk distance more than 450 meters (to exclude patients who are unlikely to truly have nyha class iii to iv heart failure)
boolean
C0430515 (UMLS CUI [1,1])
C0012751 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Study Subject Participation Status Interferes with Research results
Item
8. enrollment in any concurrent study that may confound the results of this study
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Life Expectancy
Item
9. life expectancy less than 6 months because of other medical conditions.
boolean
C0023671 (UMLS CUI [1])
Age
Item
10. age less than 18 years since this disease is not prevalent in children.
boolean
C0001779 (UMLS CUI [1])
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