ID

16747

Descrição

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

Palavras-chave

Versões (1)
  1. 03/08/2016 03/08/2016 -
Transferido a

3 de agosto de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00277875

Inglês

Eligibility Cardiovascular Disease NCT00277875

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

gender, age

Tipo de dados

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).
Descrição

diagnosis, hypertension, elevated pulse pressure

Tipo de dados

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).
Descrição

ejection fraction

Tipo de dados

boolean

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

physcial performance

Tipo de dados

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.
Descrição

informed consent

Tipo de dados

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.
Descrição

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

Tipo de dados

boolean

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

Exclusion Criteria

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

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

Tipo de dados

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).
Descrição

uncontrolled hypertension

Tipo de dados

boolean

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

atrial fibrillation, diabetes mellitus or chronic lung disease

Tipo de dados

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.
Descrição

comorbidity

Tipo de dados

boolean

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

nitrates, change in antihypertensive medication

Tipo de dados

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.
Descrição

investigational drug

Tipo de dados

boolean

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

exposure to alagebrium

Tipo de dados

boolean

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

ast, alt

Tipo de dados

boolean

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

serum creatinine

Tipo de dados

boolean

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

smoking

Tipo de dados

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.
Descrição

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

Tipo de dados

boolean

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

positive drug screen

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0743295
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Similar models

Eligibility Cardiovascular Disease NCT00277875

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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