ID

29479

Beschrijving

Effectiveness of a Walking Program Modulating Cardioreparative Factors in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00937443

Link

https://clinicaltrials.gov/show/NCT00937443

Trefwoorden

Versies (1)
  1. 03-04-18 03-04-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

3 april 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00937443

Engels

Eligibility Heart Failure NCT00937443

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects 30-65 years old.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. subjects able to give informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
3. subjects who will give permission for collection of clinical and demographic data from the electronic medical records.
Beschrijving

Permission Data Collection Electronic Health Records

Datatype

boolean

Alias
UMLS CUI [1,1]
C0521104
UMLS CUI [1,2]
C0010995
UMLS CUI [1,3]
C2362543
4. subjects with symptomatic ischemic or non-ischemic heart failure in a stable condition with new york heart association class ii-iii for at least the last 3 months before study enrollment.
Beschrijving

Heart failure Symptomatic New York Heart Association Classification | Heart failure Ischemic Symptomatic | Heart failure Stable Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0475224
UMLS CUI [2,3]
C0231220
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C0205360
UMLS CUI [3,3]
C0872146
left ventricular ejection fraction (lvef) < 40%.
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
peak volume of oxygen utilization (peak vo2) of < 25 ml/kg/min.
Beschrijving

VO2 Peak

Datatype

boolean

Alias
UMLS CUI [1,1]
C1305742
UMLS CUI [1,2]
C0444505
5. patient on a stable dose of statin or who can be initiated on statin therapy.
Beschrijving

Statin Dose Stable | Initiation Statin therapy possible

Datatype

boolean

Alias
UMLS CUI [1,1]
C0360714
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C1704686
UMLS CUI [2,2]
C1278454
UMLS CUI [2,3]
C0332149
6. subjects with ischemic cardiomyopathy must have had either a negative stress test within the last 6 months or a cardiac catheterization within the last year confirming stable disease.
Beschrijving

Ischemic cardiomyopathy Stress Test Negative | Disease Stable Cardiac Catheterization

Datatype

boolean

Alias
UMLS CUI [1,1]
C0349782
UMLS CUI [1,2]
C3494508
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0018795
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects with myocardial infarction or unstable angina within the last six months.
Beschrijving

Myocardial Infarction | Angina, Unstable

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
2. subjects with symptomatic or severe aortic stenosis.
Beschrijving

Aortic stenosis symptomatic | Aortic stenosis, severe

Datatype

boolean

Alias
UMLS CUI [1]
C0741183
UMLS CUI [2]
C3806272
3. subjects with severe htn (sbp > 180) or hypotension (sbp < 100).
Beschrijving

Hypertension, severe | Systolic Pressure | Hypotension, severe

Datatype

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2]
C0871470
UMLS CUI [3]
C2678378
4. subjects who are pregnant.
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
5. subjects who have bone marrow suppression.
Beschrijving

Bone Marrow Suppression

Datatype

boolean

Alias
UMLS CUI [1]
C0280962
6. subjects with exercise limiting peripheral arterial disease.
Beschrijving

Peripheral Arterial Disease Limiting Exercise

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704436
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0015259
7. subjects with history of ventricular tachycardia without an implantable defibrillator
Beschrijving

Tachycardia, Ventricular | Implantable defibrillator Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0042514
UMLS CUI [2,1]
C0162589
UMLS CUI [2,2]
C0332197
8. subjects with decompensated diabetes (hga1c >10).
Beschrijving

DIABETES MELLITUS DECOMPENSATED | Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0743120
UMLS CUI [2]
C0474680
9. subjects with orthopedic limitations.
Beschrijving

Orthopedic problem

Datatype

boolean

Alias
UMLS CUI [1]
C0029354
10. subjects with any other clinical condition precluding regular participation in walking exercise regimen.
Beschrijving

Medical condition Excludes Walking Exercise

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0080331
UMLS CUI [1,4]
C0015259
11. subjects who already participate in regular physical exercise regimen for greater than 30 minutes a day 5 days per week.
Beschrijving

Participates in regular exercise Duration Frequency

Datatype

boolean

Alias
UMLS CUI [1,1]
C1821438
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0439603
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Similar models

Eligibility Heart Failure NCT00937443

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. subjects 30-65 years old.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
2. subjects able to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Permission Data Collection Electronic Health Records
Item
3. subjects who will give permission for collection of clinical and demographic data from the electronic medical records.
boolean
C0521104 (UMLS CUI [1,1])
C0010995 (UMLS CUI [1,2])
C2362543 (UMLS CUI [1,3])
Heart failure Symptomatic New York Heart Association Classification | Heart failure Ischemic Symptomatic | Heart failure Stable Disease length
Item
4. subjects with symptomatic ischemic or non-ischemic heart failure in a stable condition with new york heart association class ii-iii for at least the last 3 months before study enrollment.
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0475224 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
C0018801 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0872146 (UMLS CUI [3,3])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) < 40%.
boolean
C0428772 (UMLS CUI [1])
VO2 Peak
Item
peak volume of oxygen utilization (peak vo2) of < 25 ml/kg/min.
boolean
C1305742 (UMLS CUI [1,1])
C0444505 (UMLS CUI [1,2])
Statin Dose Stable | Initiation Statin therapy possible
Item
5. patient on a stable dose of statin or who can be initiated on statin therapy.
boolean
C0360714 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1704686 (UMLS CUI [2,1])
C1278454 (UMLS CUI [2,2])
C0332149 (UMLS CUI [2,3])
Ischemic cardiomyopathy Stress Test Negative | Disease Stable Cardiac Catheterization
Item
6. subjects with ischemic cardiomyopathy must have had either a negative stress test within the last 6 months or a cardiac catheterization within the last year confirming stable disease.
boolean
C0349782 (UMLS CUI [1,1])
C3494508 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0018795 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Myocardial Infarction | Angina, Unstable
Item
1. subjects with myocardial infarction or unstable angina within the last six months.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Aortic stenosis symptomatic | Aortic stenosis, severe
Item
2. subjects with symptomatic or severe aortic stenosis.
boolean
C0741183 (UMLS CUI [1])
C3806272 (UMLS CUI [2])
Hypertension, severe | Systolic Pressure | Hypotension, severe
Item
3. subjects with severe htn (sbp > 180) or hypotension (sbp < 100).
boolean
C4013784 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C2678378 (UMLS CUI [3])
Pregnancy
Item
4. subjects who are pregnant.
boolean
C0032961 (UMLS CUI [1])
Bone Marrow Suppression
Item
5. subjects who have bone marrow suppression.
boolean
C0280962 (UMLS CUI [1])
Peripheral Arterial Disease Limiting Exercise
Item
6. subjects with exercise limiting peripheral arterial disease.
boolean
C1704436 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
Tachycardia, Ventricular | Implantable defibrillator Absent
Item
7. subjects with history of ventricular tachycardia without an implantable defibrillator
boolean
C0042514 (UMLS CUI [1])
C0162589 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
DIABETES MELLITUS DECOMPENSATED | Hemoglobin A1c measurement
Item
8. subjects with decompensated diabetes (hga1c >10).
boolean
C0743120 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Orthopedic problem
Item
9. subjects with orthopedic limitations.
boolean
C0029354 (UMLS CUI [1])
Medical condition Excludes Walking Exercise
Item
10. subjects with any other clinical condition precluding regular participation in walking exercise regimen.
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0080331 (UMLS CUI [1,3])
C0015259 (UMLS CUI [1,4])
Participates in regular exercise Duration Frequency
Item
11. subjects who already participate in regular physical exercise regimen for greater than 30 minutes a day 5 days per week.
boolean
C1821438 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
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