ID

16747

Beschrijving

STRETCH Study: Effect of Distensibility on Endothelial-Dependent Vasoreactivity in Patients With ISH; ODM derived from: https://clinicaltrials.gov/show/NCT00277875

Link

https://clinicaltrials.gov/show/NCT00277875

Trefwoorden

Versies (1)
  1. 03-08-16 03-08-16 -
Geüploaded op

3 augustus 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00277875

Engels

Eligibility Cardiovascular Disease NCT00277875

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female 50 years of age or greater.
Beschrijving

gender, age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. diagnosed with systolic hypertension (systolic blood pressure >140 mm hg and (less than or equal to) 200 mm hg, and a diastolic blood pressure (less than or equal to) 95 mm hg) and elevated pulse pressure (systolic blood pressure [sbp] minus diastolic blood pressure [dbp] greater than 60 mm hg).
Beschrijving

diagnosis, hypertension, elevated pulse pressure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0020538
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0855323
3. normal left ventricular function (ejection fraction >55%) at baseline (visit 3).
Beschrijving

ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0232174
4. able to perform bicycle exercise.
Beschrijving

physcial performance

Datatype

boolean

Alias
UMLS CUI [1]
C3714565
5. able to read, understand and sign the informed consent after the nature of the study has been explained.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
6. if sexually active, the patient agrees to use reliable contraception while participating in this study. if a woman, is surgically sterilized or post-menopausal, or has a negative serum pregnancy test.
Beschrijving

contraception, sexual sterilization, post-menopausal, negative serum pregnancy test

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0038288
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0430061
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. aortic stenosis, prior known coronary artery disease (including myocardial infarction), cerebrovascular accident, or peripheral vascular disease.
Beschrijving

aortic stenosis, coronary artery disease, cerebrovascular accident, or peripheral vascular disease

Datatype

boolean

Alias
UMLS CUI [1]
C0003507
UMLS CUI [2]
C1956346
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0085096
2. uncontrolled hypertension (sbp > 200/ dbp > 95 mm hg).
Beschrijving

uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
3. atrial fibrillation, diabetes mellitus treated with insulin, or chronic lung disease.
Beschrijving

atrial fibrillation, diabetes mellitus or chronic lung disease

Datatype

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0746102
4. any additional condition(s) which, in the opinion of the investigator, would prohibit the patient from completing the study, or not be in the best interest of the patient.
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
5. treatment with nitrates, or a change in antihypertensive medications within the last 1 month.
Beschrijving

nitrates, change in antihypertensive medication

Datatype

boolean

Alias
UMLS CUI [1]
C0028125
UMLS CUI [2,1]
C0580105
UMLS CUI [2,2]
C0585941
6. treatment with any investigational drug within 1 month prior to study drug administration.
Beschrijving

investigational drug

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
7. previous exposure to alagebrium.
Beschrijving

exposure to alagebrium

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0913630
8. ast (sgot) or alt (sgpt) > 2x normal limit.
Beschrijving

ast, alt

Datatype

boolean

Alias
UMLS CUI [1]
C0004002
UMLS CUI [2]
C0001899
9. serum creatinine > 2.0 ng/ml.
Beschrijving

serum creatinine

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
10. cigar/cigarette smoking.
Beschrijving

smoking

Datatype

boolean

Alias
UMLS CUI [1]
C0543414
11. necessity to use smokeless tobacco or nicotine-containing products, or to consume caffeine, alcohol, or antioxidants starting at midnight prior to study clinic visits. note: water is allowed ad libitim.
Beschrijving

smokeless tobacco or nicotine-containing products, caffeine, alcohol, or antioxidants

Datatype

boolean

Alias
UMLS CUI [1]
C0040338
UMLS CUI [2]
C0006644
UMLS CUI [3]
C0001948
UMLS CUI [4]
C0003402
12. positive drug screen.
Beschrijving

positive drug screen

Datatype

boolean

Alias
UMLS CUI [1]
C0743295
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Similar models

Eligibility Cardiovascular Disease NCT00277875

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
gender, age
Item
1. male or female 50 years of age or greater.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
diagnosis, hypertension, elevated pulse pressure
Item
2. diagnosed with systolic hypertension (systolic blood pressure >140 mm hg and (less than or equal to) 200 mm hg, and a diastolic blood pressure (less than or equal to) 95 mm hg) and elevated pulse pressure (systolic blood pressure [sbp] minus diastolic blood pressure [dbp] greater than 60 mm hg).
boolean
C0011900 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2,1])
C0855323 (UMLS CUI [2,2])
ejection fraction
Item
3. normal left ventricular function (ejection fraction >55%) at baseline (visit 3).
boolean
C0232174 (UMLS CUI [1])
physcial performance
Item
4. able to perform bicycle exercise.
boolean
C3714565 (UMLS CUI [1])
informed consent
Item
5. able to read, understand and sign the informed consent after the nature of the study has been explained.
boolean
C0021430 (UMLS CUI [1])
contraception, sexual sterilization, post-menopausal, negative serum pregnancy test
Item
6. if sexually active, the patient agrees to use reliable contraception while participating in this study. if a woman, is surgically sterilized or post-menopausal, or has a negative serum pregnancy test.
boolean
C0700589 (UMLS CUI [1])
C0038288 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0430061 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
aortic stenosis, coronary artery disease, cerebrovascular accident, or peripheral vascular disease
Item
1. aortic stenosis, prior known coronary artery disease (including myocardial infarction), cerebrovascular accident, or peripheral vascular disease.
boolean
C0003507 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0085096 (UMLS CUI [4])
uncontrolled hypertension
Item
2. uncontrolled hypertension (sbp > 200/ dbp > 95 mm hg).
boolean
C1868885 (UMLS CUI [1])
atrial fibrillation, diabetes mellitus or chronic lung disease
Item
3. atrial fibrillation, diabetes mellitus treated with insulin, or chronic lung disease.
boolean
C0004238 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0746102 (UMLS CUI [3])
comorbidity
Item
4. any additional condition(s) which, in the opinion of the investigator, would prohibit the patient from completing the study, or not be in the best interest of the patient.
boolean
C0009488 (UMLS CUI [1])
nitrates, change in antihypertensive medication
Item
5. treatment with nitrates, or a change in antihypertensive medications within the last 1 month.
boolean
C0028125 (UMLS CUI [1])
C0580105 (UMLS CUI [2,1])
C0585941 (UMLS CUI [2,2])
investigational drug
Item
6. treatment with any investigational drug within 1 month prior to study drug administration.
boolean
C0013230 (UMLS CUI [1])
exposure to alagebrium
Item
7. previous exposure to alagebrium.
boolean
C0332157 (UMLS CUI [1,1])
C0913630 (UMLS CUI [1,2])
ast, alt
Item
8. ast (sgot) or alt (sgpt) > 2x normal limit.
boolean
C0004002 (UMLS CUI [1])
C0001899 (UMLS CUI [2])
serum creatinine
Item
9. serum creatinine > 2.0 ng/ml.
boolean
C0201976 (UMLS CUI [1])
smoking
Item
10. cigar/cigarette smoking.
boolean
C0543414 (UMLS CUI [1])
smokeless tobacco or nicotine-containing products, caffeine, alcohol, or antioxidants
Item
11. necessity to use smokeless tobacco or nicotine-containing products, or to consume caffeine, alcohol, or antioxidants starting at midnight prior to study clinic visits. note: water is allowed ad libitim.
boolean
C0040338 (UMLS CUI [1])
C0006644 (UMLS CUI [2])
C0001948 (UMLS CUI [3])
C0003402 (UMLS CUI [4])
positive drug screen
Item
12. positive drug screen.
boolean
C0743295 (UMLS CUI [1])
Terug naar het begin van de pagina 

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