ID

35949

Description

A Pilot Study of Spinal Cord Stimulation in Heart Failure Patients With Depressed Left Ventricular Function; ODM derived from: https://clinicaltrials.gov/show/NCT02450110

Link

https://clinicaltrials.gov/show/NCT02450110

Keywords

Versions (1)
  1. 4/5/19 4/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02450110

English

Eligibility Heart Failure NCT02450110

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with chronic heart failure ii-iii class (nyha);
Description

Chronic heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C1275491
2. age 18-70 years;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. left ventricle ejection fraction ≤35%;
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
4. optimal heart failure management according to the guidelines;
Description

Heart failure | Disease Management Optimal

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2,1]
C0376636
UMLS CUI [2,2]
C2698651
5. signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. heart transplant list;
Description

Heart Transplantation Waiting List

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C0043010
2. acute conditions, including systemic infection;
Description

Acute Disease | Sepsis

Data type

boolean

Alias
UMLS CUI [1]
C0001314
UMLS CUI [2]
C0243026
3. reversible cause of heart failure (thyroid gland diseases, alcoholic intoxication etc);
Description

Cause Reversible Heart failure | Thyroid Diseases | Alcoholic Intoxication

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205343
UMLS CUI [1,3]
C0018801
UMLS CUI [2]
C0040128
UMLS CUI [3]
C0001969
4. planned elective heart surgery or intervention;
Description

Cardiac Surgery procedures elective Planned | Heart Intervention Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C0439608
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C0018787
UMLS CUI [2,2]
C0184661
UMLS CUI [2,3]
C1301732
5. recent (3 months) myocardial infarction, coronary intervention;
Description

Myocardial Infarction | Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C1532338
6. heart failure decompensation;
Description

Decompensated cardiac failure

Data type

boolean

Alias
UMLS CUI [1]
C0581377
7. implanted cardiac resynchronization device < 6 months ago;
Description

Cardiac Resynchronization Therapy Device Implanted

Data type

boolean

Alias
UMLS CUI [1,1]
C2936377
UMLS CUI [1,2]
C0021102
8. contraindications for lumbal puncture or placement of a spinal cord pacing electrode;
Description

Medical contraindication Spinal Puncture | Electrode implant Pacing Spinal Cord

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0037943
UMLS CUI [2,1]
C0013814
UMLS CUI [2,2]
C1285520
UMLS CUI [2,3]
C0037925
9. permanent atrial fibrillation;
Description

Permanent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2586056
10. stroke or tia < 6 months ago;
Description

Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
11. pulmonary thromboembolist < 3 months ago;
Description

Pulmonary Thromboembolism

Data type

boolean

Alias
UMLS CUI [1]
C0524702
12. hypertrophic cardiomyopathy with obstruction;
Description

HOCM

Data type

boolean

Alias
UMLS CUI [1]
C0007194
13. angina iii-iv class, or congestive heart failure iv class;
Description

Angina Pectoris New York Heart Association Classification | Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
14. participation in any other clinical trial;
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
15. women of childbearing possibility without appropriate contraception, pregnant, or breastfeeding women.
Description

Childbearing Potential Contraceptive methods Absent | Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
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Similar models

Eligibility Heart Failure NCT02450110

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic heart failure New York Heart Association Classification
Item
1. patients with chronic heart failure ii-iii class (nyha);
boolean
C0264716 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Age
Item
2. age 18-70 years;
boolean
C0001779 (UMLS CUI [1])
Left ventricular ejection fraction
Item
3. left ventricle ejection fraction ≤35%;
boolean
C0428772 (UMLS CUI [1])
Heart failure | Disease Management Optimal
Item
4. optimal heart failure management according to the guidelines;
boolean
C0018801 (UMLS CUI [1])
C0376636 (UMLS CUI [2,1])
C2698651 (UMLS CUI [2,2])
Informed Consent
Item
5. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart Transplantation Waiting List
Item
1. heart transplant list;
boolean
C0018823 (UMLS CUI [1,1])
C0043010 (UMLS CUI [1,2])
Acute Disease | Sepsis
Item
2. acute conditions, including systemic infection;
boolean
C0001314 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
Cause Reversible Heart failure | Thyroid Diseases | Alcoholic Intoxication
Item
3. reversible cause of heart failure (thyroid gland diseases, alcoholic intoxication etc);
boolean
C0015127 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0040128 (UMLS CUI [2])
C0001969 (UMLS CUI [3])
Cardiac Surgery procedures elective Planned | Heart Intervention Planned
Item
4. planned elective heart surgery or intervention;
boolean
C0018821 (UMLS CUI [1,1])
C0439608 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0018787 (UMLS CUI [2,1])
C0184661 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Myocardial Infarction | Percutaneous Coronary Intervention
Item
5. recent (3 months) myocardial infarction, coronary intervention;
boolean
C0027051 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
Decompensated cardiac failure
Item
6. heart failure decompensation;
boolean
C0581377 (UMLS CUI [1])
Cardiac Resynchronization Therapy Device Implanted
Item
7. implanted cardiac resynchronization device < 6 months ago;
boolean
C2936377 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
Medical contraindication Spinal Puncture | Electrode implant Pacing Spinal Cord
Item
8. contraindications for lumbal puncture or placement of a spinal cord pacing electrode;
boolean
C1301624 (UMLS CUI [1,1])
C0037943 (UMLS CUI [1,2])
C0013814 (UMLS CUI [2,1])
C1285520 (UMLS CUI [2,2])
C0037925 (UMLS CUI [2,3])
Permanent atrial fibrillation
Item
9. permanent atrial fibrillation;
boolean
C2586056 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack
Item
10. stroke or tia < 6 months ago;
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Pulmonary Thromboembolism
Item
11. pulmonary thromboembolist < 3 months ago;
boolean
C0524702 (UMLS CUI [1])
HOCM
Item
12. hypertrophic cardiomyopathy with obstruction;
boolean
C0007194 (UMLS CUI [1])
Angina Pectoris New York Heart Association Classification | Congestive heart failure New York Heart Association Classification
Item
13. angina iii-iv class, or congestive heart failure iv class;
boolean
C0002962 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Study Subject Participation Status
Item
14. participation in any other clinical trial;
boolean
C2348568 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Absent | Pregnancy | Breast Feeding
Item
15. women of childbearing possibility without appropriate contraception, pregnant, or breastfeeding women.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
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