ID

19767

Beschrijving

The STRETCH Study: Distensibility on Endothelial-Dependent Vasoreactivity in Subjects With Systolic Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00302250

Link

https://clinicaltrials.gov/show/NCT00302250

Trefwoorden

Versies (2)
  1. 27-01-17 27-01-17 -
  2. 27-01-17 27-01-17 -
Geüploaded op

27 januari 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00302250

Engels

Eligibility Cardiovascular Disease NCT00302250

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

boolean

Alias
UMLS CUI [1]
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

Systolic hypertension | Systolic Pressure | Diastolic blood pressure | Pulse pressure increased

Datatype

boolean

Alias
UMLS CUI [1]
C0221155
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4]
C0855323
3. normal left ventricular function (ejection fraction > 55%) at baseline (visit 3).
Beschrijving

normal left ventricular function | Cardiac ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C1532664
UMLS CUI [2]
C0232174
4. brachial artery must be able to be visualized for fmd and ppmv determinations.
Beschrijving

brachial artery Dilatation

Datatype

boolean

Alias
UMLS CUI [1,1]
C1278940
UMLS CUI [1,2]
C1322279
5. able to perform bicycle exercise.
Beschrijving

Able to ride a bicycle Exercise Related

Datatype

boolean

Alias
UMLS CUI [1,1]
C0577366
UMLS CUI [1,2]
C0015259
UMLS CUI [1,3]
C0439849
6. 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
7. if sexually active, the subject 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

Sexually active Contraceptive methods | Female Sterilization | Postmenopausal state | Gender Serum pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0241028
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0232970
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
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 | Myocardial Infarction | Cerebrovascular accident | Peripheral Vascular Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0003507
UMLS CUI [2]
C1956346
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0085096
2. uncontrolled hypertension (sbp > 200/dbp > 95 mm hg).
Beschrijving

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
3. atrial fibrillation, diabetes mellitus treated with insulin, or chronic lung disease.
Beschrijving

Atrial Fibrillation | Diabetes Mellitus insulin treatment | Chronic lung disease

Datatype

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0745343
UMLS CUI [3]
C0746102
4. any additional condition(s) which, in the opinion of the investigator, would prohibit the subject from completing the study, or not be in the best interest of the subject.
Beschrijving

Condition Excludes Clinical Trial Completion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205197
5. treatment with nitrates, or a change in antihypertensive medications within the last 1 month.
Beschrijving

Nitrates | Antihypertensive Agents Change

Datatype

boolean

Alias
UMLS CUI [1]
C0028125
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0392747
6. treatment with any investigational drug within 1 month prior to study drug administration.
Beschrijving

Investigational New Drugs

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

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
9. serum creatinine > 2.0 mg/dl.
Beschrijving

Creatinine measurement, serum

Datatype

boolean

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

Tobacco use

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

User of smokeless tobacco | Nicotine Dependence | Caffeine dependence | Alcoholic Intoxication, Chronic | Antioxidants Use

Datatype

boolean

Alias
UMLS CUI [1]
C4075678
UMLS CUI [2]
C0028043
UMLS CUI [3]
C1386553
UMLS CUI [4]
C0001973
UMLS CUI [5,1]
C0003402
UMLS CUI [5,2]
C1524063
12. positive drug screen.
Beschrijving

Drug screen positive

Datatype

boolean

Alias
UMLS CUI [1]
C0743295
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Similar models

Eligibility Cardiovascular Disease NCT00302250

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female 50 years of age or greater.
boolean
C0001779 (UMLS CUI [1])
Systolic hypertension | Systolic Pressure | Diastolic blood pressure | Pulse pressure increased
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
C0221155 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0855323 (UMLS CUI [4])
normal left ventricular function | Cardiac ejection fraction
Item
3. normal left ventricular function (ejection fraction > 55%) at baseline (visit 3).
boolean
C1532664 (UMLS CUI [1])
C0232174 (UMLS CUI [2])
brachial artery Dilatation
Item
4. brachial artery must be able to be visualized for fmd and ppmv determinations.
boolean
C1278940 (UMLS CUI [1,1])
C1322279 (UMLS CUI [1,2])
Able to ride a bicycle Exercise Related
Item
5. able to perform bicycle exercise.
boolean
C0577366 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Informed Consent
Item
6. able to read, understand and sign the informed consent after the nature of the study has been explained.
boolean
C0021430 (UMLS CUI [1])
Sexually active Contraceptive methods | Female Sterilization | Postmenopausal state | Gender Serum pregnancy test negative
Item
7. if sexually active, the subject 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
C0241028 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0430061 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Aortic Stenosis | Coronary Artery Disease | Myocardial Infarction | Cerebrovascular accident | Peripheral Vascular Diseases
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])
C0027051 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0085096 (UMLS CUI [5])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
2. uncontrolled hypertension (sbp > 200/dbp > 95 mm hg).
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Atrial Fibrillation | Diabetes Mellitus insulin treatment | Chronic lung disease
Item
3. atrial fibrillation, diabetes mellitus treated with insulin, or chronic lung disease.
boolean
C0004238 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0745343 (UMLS CUI [2,2])
C0746102 (UMLS CUI [3])
Condition Excludes Clinical Trial Completion
Item
4. any additional condition(s) which, in the opinion of the investigator, would prohibit the subject from completing the study, or not be in the best interest of the subject.
boolean
C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Nitrates | Antihypertensive Agents Change
Item
5. treatment with nitrates, or a change in antihypertensive medications within the last 1 month.
boolean
C0028125 (UMLS CUI [1])
C0003364 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
Investigational New Drugs
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])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
8. ast (sgot) or alt (sgpt) > 2x normal limit.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
9. serum creatinine > 2.0 mg/dl.
boolean
C0201976 (UMLS CUI [1])
Tobacco use
Item
10. cigar/cigarette smoking.
boolean
C0543414 (UMLS CUI [1])
User of smokeless tobacco | Nicotine Dependence | Caffeine dependence | Alcoholic Intoxication, Chronic | Antioxidants Use
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
C4075678 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
C0001973 (UMLS CUI [4])
C0003402 (UMLS CUI [5,1])
C1524063 (UMLS CUI [5,2])
Drug screen positive
Item
12. positive drug screen.
boolean
C0743295 (UMLS CUI [1])
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