ID

18274

Description

The Effect of Sildenafil Citrate (Viagra® (Registered Trademark)) on Brain Blood Flow in Multiple Sclerosis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00094068

Link

https://clinicaltrials.gov/show/NCT00094068

Keywords

Versions (2)
  1. 10/27/16 10/27/16 -
  2. 10/27/16 10/27/16 -
Uploaded on

October 27, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00094068

English

Eligibility Multiple Sclerosis NCT00094068

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
any healthy normal volunteer above the age of 18 who is capable of giving informed consent recruited or self referred through the nih volunteer office will be eligible for this study.
Description

Healthy Volunteers | Age

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0001779
all healthy normal volunteers will be included as long as there is no recorded or documented signs or symptoms of cns disease, contraindications to a mri and have a "normal age appropriate" mri of the brain.
Description

Healthy Volunteers | CNS disorder Sign or Symptom | Medical contraindication Magnetic Resonance Imaging | MRI brain procedure Normal

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0007682
UMLS CUI [2,2]
C3540840
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0024485
UMLS CUI [4,1]
C0412675
UMLS CUI [4,2]
C0205307
patients seen in the neuroimmunology ms clinic with a confirmed diagnosis of multiple sclerosis based upon previous history of two clinical neurological attacks separated in time and in spatial location or combination of clinical and mri findings of a single enhancing lesion in the brain or spine along with multiple t2 hyperintensities in the juxtacortical, periventricular or infratentorial white matter according to the mcdonald criteria will be included in this study.
Description

Multiple Sclerosis | Attack Neurologic Quantity | Magnetic Resonance Imaging | Lesion of brain | Spinal Injuries | Focal T2 hyperintense brainstem lesion | White matter Cerebral cortex Adjacent | Periventricular white matter | White matter Infratentorial

Data type

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2,1]
C1304680
UMLS CUI [2,2]
C0205494
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0024485
UMLS CUI [4]
C0221505
UMLS CUI [5]
C0037937
UMLS CUI [6]
C4022748
UMLS CUI [7,1]
C0682708
UMLS CUI [7,2]
C0007776
UMLS CUI [7,3]
C0205117
UMLS CUI [8]
C0228157
UMLS CUI [9,1]
C0682708
UMLS CUI [9,2]
C0441939
relapsing-remitting or secondary progressive ms who have had more than one relapse within 18 months preceding study enrollment will be recruited from the ms 7th floor clinic in the ninds at the nih. ms patients will have edss score between 1.0 - 6.5, inclusive. ms patients seen and treated in the ninds ms clinic are representative of the general ms population that is female: male ratio of approximately 3:2, caucasian and african american, between ages of 18-55 years old.
Description

Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Relapse Quantity | Kurtzke multiple sclerosis rating scale | Gender | Caucasian American | African American | Age

Data type

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2]
C0751965
UMLS CUI [3,1]
C0035020
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0451246
UMLS CUI [5]
C0079399
UMLS CUI [6]
C0221786
UMLS CUI [7]
C0085756
UMLS CUI [8]
C0001779
give written informed consent prior to any testing under this protocol, including screening/pre-treatment tests and evaluations that are not considered part of the patient's routine care.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
healthy controls and ms patients will be excluded if they have contraindications to mr scanning, such as the following:
Description

Medical contraindication Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
1. aneurysm clip
Description

Aneurysm clip

Data type

boolean

Alias
UMLS CUI [1]
C0179977
2. implanted neural stimulator
Description

Neurostimulator

Data type

boolean

Alias
UMLS CUI [1]
C0582124
3. implanted cardiac pacemaker or autodefibrillator
Description

Artificial cardiac pacemaker | cardiac defibrillator

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C1391956
4. cochlear implant
Description

Cochlear Implants

Data type

boolean

Alias
UMLS CUI [1]
C0009199
5. ocular foreign body (e.g., metal shavings)
Description

Ocular Foreign Body

Data type

boolean

Alias
UMLS CUI [1]
C3898107
6. insulin pump
Description

insulin pump

Data type

boolean

Alias
UMLS CUI [1]
C1140609
healthy controls and ms patients will be excluded from this study if they have the following:
Description

Healthy Control Exclusion Criteria | Multiple Sclerosis Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C2986479
UMLS CUI [1,2]
C0680251
UMLS CUI [2,1]
C0026769
UMLS CUI [2,2]
C0680251
1. history of heart attack
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
2. history of treatment with nitrates for heart condition
Description

Nitrates Heart condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0028125
UMLS CUI [1,2]
C3842523
3. history of carotid artery stenosis or evidence of greater than 50% carotid stenosis on screening mr angiogram
Description

Carotid Stenosis | Carotid Stenosis Percentage Evidence | Magnetic Resonance Angiography

Data type

boolean

Alias
UMLS CUI [1]
C0007282
UMLS CUI [2,1]
C0007282
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C3887511
UMLS CUI [3]
C0243032
4. history of known vascular disease
Description

Vascular Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0042373
5. history of stroke
Description

Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0038454
6. history of migraine
Description

Migraine Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0149931
7. subjects who have a history of a reaction to mr contrast agents specifically gadopentetate dimeglumine will be excluded from participating in the contrast agent administration part of this protocol.
Description

Allergic Reaction Magnetic resonance imaging contrast media | Allergic Reaction Gadopentetate Dimeglumine

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0180108
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0060934
8. healthy controls will be excluded if have history of alcohol or drug abuse.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
9. healthy controls will be excluded if concurrent, clinically significant (as determined by the investigator) gastrointestinal, immunologic, pulmonary, neurologic, renal, and/or other major disease.
Description

Gastrointestinal Diseases Clinical Significance | Immune System Diseases Clinical Significance | Lung diseases Clinical Significance | nervous system disorder Clinical Significance | Kidney Diseases Clinical Significance | Disease Major

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0021053
UMLS CUI [2,2]
C2826293
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C2826293
UMLS CUI [4,1]
C0027765
UMLS CUI [4,2]
C2826293
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C2826293
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0205164
10. healthy controls will be excluded if they have a previous known abnormality on brain mri examination.
Description

MRI brain procedure Abnormality

Data type

boolean

Alias
UMLS CUI [1,1]
C0412675
UMLS CUI [1,2]
C1704258
11. pregnant and lactating women will be excluded from the study.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
12. since certain drugs may interfere with the ability of the vessels in your brain to respond to viagra, subjects taking steroids or sildenafil (within 24 hours) will be excluded from this study.
Description

Steroids | sildenafil | Viagra

Data type

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C0529793
UMLS CUI [3]
C0663448
ms patients will also be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment:
Description

Exclusion Criteria Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0026769
1. pregnant and lactating women who are ms patients will be excluded from the study.
Description

Pregnancy | Breast Feeding | Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0026769
2. diagnosis of primary progressive ms, defined as gradual progression of disability from the onset without relapses.
Description

Multiple Sclerosis, Primary Progressive | Gradual progression Disability | Relapse

Data type

boolean

Alias
UMLS CUI [1]
C0751964
UMLS CUI [2,1]
C1854645
UMLS CUI [2,2]
C0231170
UMLS CUI [3]
C0035020
3. concurrent, clinically significant (as determined by the investigator) immunologic, pulmonary, gastrointestinal, neurologic, renal, and/or other major disease in ms patients.
Description

Immune System Diseases Clinical Significance | Lung diseases Clinical Significance | Gastrointestinal Diseases Clinical Significance | nervous system disorder Clinical Significance | Kidney Diseases Clinical Significance | Disease Major | Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0021053
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C2826293
UMLS CUI [3,1]
C0017178
UMLS CUI [3,2]
C2826293
UMLS CUI [4,1]
C0027765
UMLS CUI [4,2]
C2826293
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C2826293
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0205164
UMLS CUI [7]
C0026769
treatment history in ms patients
Description

Therapeutic procedure Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0026769
if prior treatment with steroids was received, the subject must have been off treatment for the required period prior to enrollment (see below).
Description

Steroids To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C1272691
agent: corticosteroids
Description

Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0001617
time required off agent prior to enrollment: 8 weeks
Description

Period Requirement Pharmaceutical Preparations To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C1948053
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C1272691
unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returning for follow-up visits to the ninds, neuroimmunology clinic will be sufficient reason to exclude a subject.
Description

Protocol Compliance Unwilling | Condition Affecting Follow-up visits

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0589121
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Similar models

Eligibility Multiple Sclerosis NCT00094068

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers | Age
Item
any healthy normal volunteer above the age of 18 who is capable of giving informed consent recruited or self referred through the nih volunteer office will be eligible for this study.
boolean
C1708335 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Healthy Volunteers | CNS disorder Sign or Symptom | Medical contraindication Magnetic Resonance Imaging | MRI brain procedure Normal
Item
all healthy normal volunteers will be included as long as there is no recorded or documented signs or symptoms of cns disease, contraindications to a mri and have a "normal age appropriate" mri of the brain.
boolean
C1708335 (UMLS CUI [1])
C0007682 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
C0412675 (UMLS CUI [4,1])
C0205307 (UMLS CUI [4,2])
Multiple Sclerosis | Attack Neurologic Quantity | Magnetic Resonance Imaging | Lesion of brain | Spinal Injuries | Focal T2 hyperintense brainstem lesion | White matter Cerebral cortex Adjacent | Periventricular white matter | White matter Infratentorial
Item
patients seen in the neuroimmunology ms clinic with a confirmed diagnosis of multiple sclerosis based upon previous history of two clinical neurological attacks separated in time and in spatial location or combination of clinical and mri findings of a single enhancing lesion in the brain or spine along with multiple t2 hyperintensities in the juxtacortical, periventricular or infratentorial white matter according to the mcdonald criteria will be included in this study.
boolean
C0026769 (UMLS CUI [1])
C1304680 (UMLS CUI [2,1])
C0205494 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0024485 (UMLS CUI [3])
C0221505 (UMLS CUI [4])
C0037937 (UMLS CUI [5])
C4022748 (UMLS CUI [6])
C0682708 (UMLS CUI [7,1])
C0007776 (UMLS CUI [7,2])
C0205117 (UMLS CUI [7,3])
C0228157 (UMLS CUI [8])
C0682708 (UMLS CUI [9,1])
C0441939 (UMLS CUI [9,2])
Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Relapse Quantity | Kurtzke multiple sclerosis rating scale | Gender | Caucasian American | African American | Age
Item
relapsing-remitting or secondary progressive ms who have had more than one relapse within 18 months preceding study enrollment will be recruited from the ms 7th floor clinic in the ninds at the nih. ms patients will have edss score between 1.0 - 6.5, inclusive. ms patients seen and treated in the ninds ms clinic are representative of the general ms population that is female: male ratio of approximately 3:2, caucasian and african american, between ages of 18-55 years old.
boolean
C0751967 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0035020 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0451246 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
C0221786 (UMLS CUI [6])
C0085756 (UMLS CUI [7])
C0001779 (UMLS CUI [8])
Informed Consent
Item
give written informed consent prior to any testing under this protocol, including screening/pre-treatment tests and evaluations that are not considered part of the patient's routine care.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Magnetic Resonance Imaging
Item
healthy controls and ms patients will be excluded if they have contraindications to mr scanning, such as the following:
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Aneurysm clip
Item
1. aneurysm clip
boolean
C0179977 (UMLS CUI [1])
Neurostimulator
Item
2. implanted neural stimulator
boolean
C0582124 (UMLS CUI [1])
Artificial cardiac pacemaker | cardiac defibrillator
Item
3. implanted cardiac pacemaker or autodefibrillator
boolean
C0030163 (UMLS CUI [1])
C1391956 (UMLS CUI [2])
Cochlear Implants
Item
4. cochlear implant
boolean
C0009199 (UMLS CUI [1])
Ocular Foreign Body
Item
5. ocular foreign body (e.g., metal shavings)
boolean
C3898107 (UMLS CUI [1])
insulin pump
Item
6. insulin pump
boolean
C1140609 (UMLS CUI [1])
Healthy Control Exclusion Criteria | Multiple Sclerosis Exclusion Criteria
Item
healthy controls and ms patients will be excluded from this study if they have the following:
boolean
C2986479 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0026769 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
Myocardial Infarction
Item
1. history of heart attack
boolean
C0027051 (UMLS CUI [1])
Nitrates Heart condition
Item
2. history of treatment with nitrates for heart condition
boolean
C0028125 (UMLS CUI [1,1])
C3842523 (UMLS CUI [1,2])
Carotid Stenosis | Carotid Stenosis Percentage Evidence | Magnetic Resonance Angiography
Item
3. history of carotid artery stenosis or evidence of greater than 50% carotid stenosis on screening mr angiogram
boolean
C0007282 (UMLS CUI [1])
C0007282 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C3887511 (UMLS CUI [2,3])
C0243032 (UMLS CUI [3])
Vascular Diseases
Item
4. history of known vascular disease
boolean
C0042373 (UMLS CUI [1])
Cerebrovascular accident
Item
5. history of stroke
boolean
C0038454 (UMLS CUI [1])
Migraine Disorders
Item
6. history of migraine
boolean
C0149931 (UMLS CUI [1])
Allergic Reaction Magnetic resonance imaging contrast media | Allergic Reaction Gadopentetate Dimeglumine
Item
7. subjects who have a history of a reaction to mr contrast agents specifically gadopentetate dimeglumine will be excluded from participating in the contrast agent administration part of this protocol.
boolean
C1527304 (UMLS CUI [1,1])
C0180108 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0060934 (UMLS CUI [2,2])
Substance Use Disorders
Item
8. healthy controls will be excluded if have history of alcohol or drug abuse.
boolean
C0038586 (UMLS CUI [1])
Gastrointestinal Diseases Clinical Significance | Immune System Diseases Clinical Significance | Lung diseases Clinical Significance | nervous system disorder Clinical Significance | Kidney Diseases Clinical Significance | Disease Major
Item
9. healthy controls will be excluded if concurrent, clinically significant (as determined by the investigator) gastrointestinal, immunologic, pulmonary, neurologic, renal, and/or other major disease.
boolean
C0017178 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0021053 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0024115 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0027765 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C0012634 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
MRI brain procedure Abnormality
Item
10. healthy controls will be excluded if they have a previous known abnormality on brain mri examination.
boolean
C0412675 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
11. pregnant and lactating women will be excluded from the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Steroids | sildenafil | Viagra
Item
12. since certain drugs may interfere with the ability of the vessels in your brain to respond to viagra, subjects taking steroids or sildenafil (within 24 hours) will be excluded from this study.
boolean
C0038317 (UMLS CUI [1])
C0529793 (UMLS CUI [2])
C0663448 (UMLS CUI [3])
Exclusion Criteria Multiple Sclerosis
Item
ms patients will also be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment:
boolean
C0680251 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Multiple Sclerosis
Item
1. pregnant and lactating women who are ms patients will be excluded from the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0026769 (UMLS CUI [3])
Multiple Sclerosis, Primary Progressive | Gradual progression Disability | Relapse
Item
2. diagnosis of primary progressive ms, defined as gradual progression of disability from the onset without relapses.
boolean
C0751964 (UMLS CUI [1])
C1854645 (UMLS CUI [2,1])
C0231170 (UMLS CUI [2,2])
C0035020 (UMLS CUI [3])
Immune System Diseases Clinical Significance | Lung diseases Clinical Significance | Gastrointestinal Diseases Clinical Significance | nervous system disorder Clinical Significance | Kidney Diseases Clinical Significance | Disease Major | Multiple Sclerosis
Item
3. concurrent, clinically significant (as determined by the investigator) immunologic, pulmonary, gastrointestinal, neurologic, renal, and/or other major disease in ms patients.
boolean
C0021053 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0017178 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0027765 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C0012634 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C0026769 (UMLS CUI [7])
Therapeutic procedure Multiple Sclerosis
Item
treatment history in ms patients
boolean
C0087111 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
Steroids To be stopped
Item
if prior treatment with steroids was received, the subject must have been off treatment for the required period prior to enrollment (see below).
boolean
C0038317 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Adrenal Cortex Hormones
Item
agent: corticosteroids
boolean
C0001617 (UMLS CUI [1])
Period Requirement Pharmaceutical Preparations To be stopped
Item
time required off agent prior to enrollment: 8 weeks
boolean
C1948053 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1272691 (UMLS CUI [1,4])
Protocol Compliance Unwilling | Condition Affecting Follow-up visits
Item
unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returning for follow-up visits to the ninds, neuroimmunology clinic will be sufficient reason to exclude a subject.
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0589121 (UMLS CUI [2,3])
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