ID

42955

Description

Sodium Channel Splicing in Heart Failure Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01185587

Link

https://clinicaltrials.gov/show/NCT01185587

Keywords

Versions (2)
  1. 7/31/19 7/31/19 -
  2. 9/17/21 9/17/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01185587

English

Eligibility Atrial Fibrillation NCT01185587

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. all patients must be greater than 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with reduced left ventricular function (i.e., heart failure patients) must have acquired heart failure and an ejection fraction less than 35% documented in the last two years by any methodology
Description

Left Ventricular Function Reduced | Heart failure | Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1,1]
C0080310
UMLS CUI [1,2]
C0392756
UMLS CUI [2]
C0018801
UMLS CUI [3]
C0232174
3. control population patients must be free of heart failure symptoms, diastolic dysfunction, and left ventricular systolic dysfunction documented by any methodology within 1 year of study enrollment
Description

Control Group | Free of Heart failure Symptoms | Free of Diastolic dysfunction | Free of Left ventricular systolic dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0009932
UMLS CUI [2,1]
C0332296
UMLS CUI [2,2]
C0018801
UMLS CUI [2,3]
C1457887
UMLS CUI [3,1]
C0332296
UMLS CUI [3,2]
C0520863
UMLS CUI [4,1]
C0332296
UMLS CUI [4,2]
C1277187
4. patients with an icd in place for more than 1 year and evidence of icd events
Description

ICD Duration | ICD Events

Data type

boolean

Alias
UMLS CUI [1,1]
C0162589
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0162589
UMLS CUI [2,2]
C0441471
5. patients with an icd in place for more than 1 year and no evidence of icd events
Description

ICD Duration | ICD Events Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0162589
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0162589
UMLS CUI [2,2]
C0441471
UMLS CUI [2,3]
C0332197
6. all patients must be able to give informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients less than 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. history of congenital heart disease as cause of impaired left ventricular function.
Description

Impaired left ventricular function caused by Congenital heart disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0242698
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0152021
3. control patients with impaired left ventricular systolic function or the presence of diastolic dysfunction.
Description

Control Group | LEFT VENTRICULAR FUNCTION SYSTOLIC DYSFUNCTION | Diastolic dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0009932
UMLS CUI [2]
C0745679
UMLS CUI [3]
C0520863
4. control or study group patients with a history of congenital electrophysiological disorders like the long-qt syndrome or brugada disease will not be included.
Description

Control Group | Study Subject | Long QT Syndrome | Brugada Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0009932
UMLS CUI [2]
C0681850
UMLS CUI [3]
C0023976
UMLS CUI [4]
C1142166
5. control or study group patients who require antiarrhythmic drugs other than vaughn-williams class ii and iv agents.
Description

Control Group | Study Subject | Requirement Anti-Arrhythmia Agents | Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C0009932
UMLS CUI [2]
C0681850
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0003195
UMLS CUI [4]
C3846158
6. control patients with a history of significant illness that may otherwise impair cardiac function within 12 months of study enrollment. these conditions include: myocardial infarction, cardiac hospitalization, cardiac arrhythmia, infection, or cancer.
Description

Control Group | Illness Impairing Cardiac function | Myocardial Infarction | Hospitalization Due to Cardiac problem | Cardiac Arrhythmia | Communicable Disease | Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0009932
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0232164
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0019993
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0262402
UMLS CUI [5]
C0003811
UMLS CUI [6]
C0009450
UMLS CUI [7]
C0006826
7. icd patients suffering from any other terminal or chronic inflammatory illness.
Description

ICD Patients | Terminal illness | Chronic inflammatory disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0162589
UMLS CUI [1,2]
C0030705
UMLS CUI [2]
C0679247
UMLS CUI [3]
C1290886
8. patients taking immunosuppressive medications, have chronic infection, or have an acute or chronic inflammatory illness that might alter white cell mrna expression.
Description

Immunosuppressive Agents | Chronic infectious disease | Inflammatory disorder | Chronic inflammatory disorder

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0151317
UMLS CUI [3]
C1290884
UMLS CUI [4]
C1290886
9. patients with any illness expected to result in death within 18 months of enrollment.
Description

Illness Resulting in Death

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0011065
10. patients with white blood cell dyscrasia or cancers.
Description

White blood cell Dyscrasia | White blood cell Cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0023516
UMLS CUI [1,2]
C0334044
UMLS CUI [2,1]
C0023516
UMLS CUI [2,2]
C0006826
11. current illicit drug use.
Description

Illicit medication use

Data type

boolean

Alias
UMLS CUI [1]
C0281875
12. inability to give informed consent.
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Atrial Fibrillation NCT01185587

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. all patients must be greater than 18 years of age
boolean
C0001779 (UMLS CUI [1])
Left Ventricular Function Reduced | Heart failure | Cardiac ejection fraction
Item
2. patients with reduced left ventricular function (i.e., heart failure patients) must have acquired heart failure and an ejection fraction less than 35% documented in the last two years by any methodology
boolean
C0080310 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2])
C0232174 (UMLS CUI [3])
Control Group | Free of Heart failure Symptoms | Free of Diastolic dysfunction | Free of Left ventricular systolic dysfunction
Item
3. control population patients must be free of heart failure symptoms, diastolic dysfunction, and left ventricular systolic dysfunction documented by any methodology within 1 year of study enrollment
boolean
C0009932 (UMLS CUI [1])
C0332296 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0332296 (UMLS CUI [3,1])
C0520863 (UMLS CUI [3,2])
C0332296 (UMLS CUI [4,1])
C1277187 (UMLS CUI [4,2])
ICD Duration | ICD Events
Item
4. patients with an icd in place for more than 1 year and evidence of icd events
boolean
C0162589 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0162589 (UMLS CUI [2,1])
C0441471 (UMLS CUI [2,2])
ICD Duration | ICD Events Absent
Item
5. patients with an icd in place for more than 1 year and no evidence of icd events
boolean
C0162589 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0162589 (UMLS CUI [2,1])
C0441471 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Informed Consent
Item
6. all patients must be able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. patients less than 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Impaired left ventricular function caused by Congenital heart disease
Item
2. history of congenital heart disease as cause of impaired left ventricular function.
boolean
C0242698 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0152021 (UMLS CUI [1,3])
Control Group | LEFT VENTRICULAR FUNCTION SYSTOLIC DYSFUNCTION | Diastolic dysfunction
Item
3. control patients with impaired left ventricular systolic function or the presence of diastolic dysfunction.
boolean
C0009932 (UMLS CUI [1])
C0745679 (UMLS CUI [2])
C0520863 (UMLS CUI [3])
Control Group | Study Subject | Long QT Syndrome | Brugada Syndrome
Item
4. control or study group patients with a history of congenital electrophysiological disorders like the long-qt syndrome or brugada disease will not be included.
boolean
C0009932 (UMLS CUI [1])
C0681850 (UMLS CUI [2])
C0023976 (UMLS CUI [3])
C1142166 (UMLS CUI [4])
Control Group | Study Subject | Requirement Anti-Arrhythmia Agents | Other Coding
Item
5. control or study group patients who require antiarrhythmic drugs other than vaughn-williams class ii and iv agents.
boolean
C0009932 (UMLS CUI [1])
C0681850 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0003195 (UMLS CUI [3,2])
C3846158 (UMLS CUI [4])
Control Group | Illness Impairing Cardiac function | Myocardial Infarction | Hospitalization Due to Cardiac problem | Cardiac Arrhythmia | Communicable Disease | Malignant Neoplasm
Item
6. control patients with a history of significant illness that may otherwise impair cardiac function within 12 months of study enrollment. these conditions include: myocardial infarction, cardiac hospitalization, cardiac arrhythmia, infection, or cancer.
boolean
C0009932 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0232164 (UMLS CUI [2,3])
C0027051 (UMLS CUI [3])
C0019993 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0262402 (UMLS CUI [4,3])
C0003811 (UMLS CUI [5])
C0009450 (UMLS CUI [6])
C0006826 (UMLS CUI [7])
ICD Patients | Terminal illness | Chronic inflammatory disorder
Item
7. icd patients suffering from any other terminal or chronic inflammatory illness.
boolean
C0162589 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0679247 (UMLS CUI [2])
C1290886 (UMLS CUI [3])
Immunosuppressive Agents | Chronic infectious disease | Inflammatory disorder | Chronic inflammatory disorder
Item
8. patients taking immunosuppressive medications, have chronic infection, or have an acute or chronic inflammatory illness that might alter white cell mrna expression.
boolean
C0021081 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C1290884 (UMLS CUI [3])
C1290886 (UMLS CUI [4])
Illness Resulting in Death
Item
9. patients with any illness expected to result in death within 18 months of enrollment.
boolean
C0221423 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0011065 (UMLS CUI [1,3])
White blood cell Dyscrasia | White blood cell Cancer
Item
10. patients with white blood cell dyscrasia or cancers.
boolean
C0023516 (UMLS CUI [1,1])
C0334044 (UMLS CUI [1,2])
C0023516 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
Illicit medication use
Item
11. current illicit drug use.
boolean
C0281875 (UMLS CUI [1])
Informed Consent Unable
Item
12. inability to give informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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