ID

35949

Beschrijving

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

Trefwoorden

Versies (1)
  1. 05-04-19 05-04-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 april 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02450110

Engels

Eligibility Heart Failure NCT02450110

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Chronic heart failure New York Heart Association Classification

Datatype

boolean

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

Age

Datatype

boolean

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

Left ventricular ejection fraction

Datatype

boolean

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

Heart failure | Disease Management Optimal

Datatype

boolean

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

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. heart transplant list;
Beschrijving

Heart Transplantation Waiting List

Datatype

boolean

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

Acute Disease | Sepsis

Datatype

boolean

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

Cause Reversible Heart failure | Thyroid Diseases | Alcoholic Intoxication

Datatype

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;
Beschrijving

Cardiac Surgery procedures elective Planned | Heart Intervention Planned

Datatype

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;
Beschrijving

Myocardial Infarction | Percutaneous Coronary Intervention

Datatype

boolean

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

Decompensated cardiac failure

Datatype

boolean

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

Cardiac Resynchronization Therapy Device Implanted

Datatype

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;
Beschrijving

Medical contraindication Spinal Puncture | Electrode implant Pacing Spinal Cord

Datatype

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;
Beschrijving

Permanent atrial fibrillation

Datatype

boolean

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

Cerebrovascular accident | Transient Ischemic Attack

Datatype

boolean

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

Pulmonary Thromboembolism

Datatype

boolean

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

HOCM

Datatype

boolean

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

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

Datatype

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;
Beschrijving

Study Subject Participation Status

Datatype

boolean

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

Childbearing Potential Contraceptive methods Absent | Pregnancy | Breast Feeding

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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