ID

16879

Beschreibung

Effect of Nitric Oxide Donor on Endothelial Progenitor Cells in Patients With Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00090558

Link

https://clinicaltrials.gov/show/NCT00090558

Stichworte

Versionen (1)
  1. 11.08.16 11.08.16 -
Hochgeladen am

11. August 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00090558

Englisch

Eligibility Coronary Artery Disease NCT00090558

1 Formulare  
Criteria
Beschreibung

Criteria

1. adults older than 21 years.
Beschreibung

Age | Adult

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0001675
2. coronary artery disease established by angiography.
Beschreibung

Coronary Artery Disease | angiography

Datentyp

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0002978
3. no myocardial infarction within 1 month.
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
4. left ventricular ejection fraction greater than 30%.
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
5. no congestive heart failure symptoms within 2 months.
Beschreibung

Congestive heart failure Symptoms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1457887
6. no associated medical, neurological or orthopedic condition that might prohibit safe performance of exercise.
Beschreibung

medical condition Excludes Exercise performance Successful | nervous system disorder Excludes Exercise performance Successful | orthopedic problem Excludes Exercise performance Successful

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0015259
UMLS CUI [1,4]
C1882330
UMLS CUI [1,5]
C1272703
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0015259
UMLS CUI [2,4]
C1882330
UMLS CUI [2,5]
C1272703
UMLS CUI [3,1]
C0029354
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0015259
UMLS CUI [3,4]
C1882330
UMLS CUI [3,5]
C1272703
7. subject understands protocol and provides written, informed consent in addition to willingness to comply with specified follow-up evaluations.
Beschreibung

Informed Consent | Protocol Compliance | Follow-up Evaluation

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
UMLS CUI [3,1]
C3274571
UMLS CUI [3,2]
C1261322
patient exclusion criteria
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
1. significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, valvular heart disease) as determined by echocardiography.
Beschreibung

Structural disorder of heart Significant | Hypertrophic Cardiomyopathy | Cardiomyopathy, Dilated | Heart valve disease | Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1290384
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0007194
UMLS CUI [3]
C0007193
UMLS CUI [4]
C0018824
UMLS CUI [5]
C0013516
2. history of recent (within 2 months) rest or nocturnal angina
Beschreibung

Angina, Unstable | Nocturnal angina

Datentyp

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0264679
3. organic nitrate (e.g., nitroglycerin) use other than study medication within 24 hours of exercise testing
Beschreibung

Nitrate organic | Nitroglycerin | Investigational New Drugs | Exercise testing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0028125
UMLS CUI [1,2]
C0747055
UMLS CUI [2]
C0017887
UMLS CUI [3]
C0013230
UMLS CUI [4]
C0015260
4. hypersensitivity to organic nitrates.
Beschreibung

Hypersensitivity Nitrates organic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0028125
UMLS CUI [1,3]
C0747055
5. women of childbearing age unless recent pregnancy test is negative.
Beschreibung

Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
6. lactating women.
Beschreibung

Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
eligibility criteria - healthy subjects
Beschreibung

Eligibility Criteria | Healthy Subjects

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
UMLS CUI [2]
C1708335
healthy subjects must be older than 50 years of age (to approximate the anticipated age of cad patients), without known cad, and be free of the following risk factors: blood pressure greater than 140/90 mmhg, fasting glucose greater than 110 mg/dl, smoking, total cholesterol greater than 250 mg/dl. healthy subjects taking chronic prescription medications will be excluded.
Beschreibung

Healthy Subjects | Age | Coronary Artery Disease | Risk factors Free of | Blood Pressure | Glucose measurement, fasting | Smoking | Serum total cholesterol measurement | Drug Prescriptions chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0001779
UMLS CUI [3]
C1956346
UMLS CUI [4,1]
C0035648
UMLS CUI [4,2]
C0332296
UMLS CUI [5]
C0005823
UMLS CUI [6]
C0202045
UMLS CUI [7]
C0037369
UMLS CUI [8]
C1445957
UMLS CUI [9,1]
C0033081
UMLS CUI [9,2]
C0205191
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT00090558

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age | Adult
Item
1. adults older than 21 years.
boolean
C0001779 (UMLS CUI [1])
C0001675 (UMLS CUI [2])
Coronary Artery Disease | angiography
Item
2. coronary artery disease established by angiography.
boolean
C1956346 (UMLS CUI [1])
C0002978 (UMLS CUI [2])
Myocardial Infarction
Item
3. no myocardial infarction within 1 month.
boolean
C0027051 (UMLS CUI [1])
Left ventricular ejection fraction
Item
4. left ventricular ejection fraction greater than 30%.
boolean
C0428772 (UMLS CUI [1])
Congestive heart failure Symptoms
Item
5. no congestive heart failure symptoms within 2 months.
boolean
C0018802 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
medical condition Excludes Exercise performance Successful | nervous system disorder Excludes Exercise performance Successful | orthopedic problem Excludes Exercise performance Successful
Item
6. no associated medical, neurological or orthopedic condition that might prohibit safe performance of exercise.
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C1882330 (UMLS CUI [1,4])
C1272703 (UMLS CUI [1,5])
C0027765 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0015259 (UMLS CUI [2,3])
C1882330 (UMLS CUI [2,4])
C1272703 (UMLS CUI [2,5])
C0029354 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0015259 (UMLS CUI [3,3])
C1882330 (UMLS CUI [3,4])
C1272703 (UMLS CUI [3,5])
Informed Consent | Protocol Compliance | Follow-up Evaluation
Item
7. subject understands protocol and provides written, informed consent in addition to willingness to comply with specified follow-up evaluations.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C3274571 (UMLS CUI [3,1])
C1261322 (UMLS CUI [3,2])
Exclusion Criteria
Item
patient exclusion criteria
boolean
C0680251 (UMLS CUI [1])
Structural disorder of heart Significant | Hypertrophic Cardiomyopathy | Cardiomyopathy, Dilated | Heart valve disease | Echocardiography
Item
1. significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, valvular heart disease) as determined by echocardiography.
boolean
C1290384 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0007194 (UMLS CUI [2])
C0007193 (UMLS CUI [3])
C0018824 (UMLS CUI [4])
C0013516 (UMLS CUI [5])
Angina, Unstable | Nocturnal angina
Item
2. history of recent (within 2 months) rest or nocturnal angina
boolean
C0002965 (UMLS CUI [1])
C0264679 (UMLS CUI [2])
Nitrate organic | Nitroglycerin | Investigational New Drugs | Exercise testing
Item
3. organic nitrate (e.g., nitroglycerin) use other than study medication within 24 hours of exercise testing
boolean
C0028125 (UMLS CUI [1,1])
C0747055 (UMLS CUI [1,2])
C0017887 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C0015260 (UMLS CUI [4])
Hypersensitivity Nitrates organic
Item
4. hypersensitivity to organic nitrates.
boolean
C0020517 (UMLS CUI [1,1])
C0028125 (UMLS CUI [1,2])
C0747055 (UMLS CUI [1,3])
Childbearing Potential Pregnancy test negative
Item
5. women of childbearing age unless recent pregnancy test is negative.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Breast Feeding
Item
6. lactating women.
boolean
C0006147 (UMLS CUI [1])
Eligibility Criteria | Healthy Subjects
Item
eligibility criteria - healthy subjects
boolean
C1516637 (UMLS CUI [1])
C1708335 (UMLS CUI [2])
Healthy Subjects | Age | Coronary Artery Disease | Risk factors Free of | Blood Pressure | Glucose measurement, fasting | Smoking | Serum total cholesterol measurement | Drug Prescriptions chronic
Item
healthy subjects must be older than 50 years of age (to approximate the anticipated age of cad patients), without known cad, and be free of the following risk factors: blood pressure greater than 140/90 mmhg, fasting glucose greater than 110 mg/dl, smoking, total cholesterol greater than 250 mg/dl. healthy subjects taking chronic prescription medications will be excluded.
boolean
C1708335 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1956346 (UMLS CUI [3])
C0035648 (UMLS CUI [4,1])
C0332296 (UMLS CUI [4,2])
C0005823 (UMLS CUI [5])
C0202045 (UMLS CUI [6])
C0037369 (UMLS CUI [7])
C1445957 (UMLS CUI [8])
C0033081 (UMLS CUI [9,1])
C0205191 (UMLS CUI [9,2])
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