ID

20857

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00359372

Stichworte

Versionen (1)
  1. 22.03.17 22.03.17 -
Hochgeladen am

22. März 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00359372

Englisch

Eligibility Heart Failure NCT00359372

1 Formulare  
Criteria
Beschreibung

Criteria

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

Racial group Any | Gender Both | Ethnic group Any

Datentyp

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
Beschreibung

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).
Beschreibung

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

Datentyp

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
Beschreibung

New York Heart Association Classification Functional Status

Datentyp

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)
Beschreibung

electrocardiogram: QRS interval

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Datentyp

boolean

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

Tachyarrhythmia Atrial chronic

Datentyp

boolean

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

Patient Non-Compliance

Datentyp

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).
Beschreibung

Pregnancy Contraceptive methods Missing | Gadolinium Risk Fetal

Datentyp

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:
Beschreibung

Medical contraindication Magnetic Resonance Imaging

Datentyp

boolean

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

Central Nervous System Aneurysm clip

Datentyp

boolean

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

Neurostimulator Implanted

Datentyp

boolean

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

implanted pacemaker | defibrillator implanted

Datentyp

boolean

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

Cochlear Implant

Datentyp

boolean

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

Ocular Foreign Body

Datentyp

boolean

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

Insulin pump

Datentyp

boolean

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

Shrapnel | Bullet

Datentyp

boolean

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

Medical contraindication Magnetic resonance imaging contrast media

Datentyp

boolean

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

Breast Feeding

Datentyp

boolean

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

Hemoglobinopathies

Datentyp

boolean

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

Kidney Disease Severe | Creatinine clearance measurement

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Study Subject Participation Status Interferes with Research results

Datentyp

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.
Beschreibung

Life Expectancy

Datentyp

boolean

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

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
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Ähnliche Modelle

Eligibility Heart Failure NCT00359372

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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