Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-03-25
2021-08-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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SLE Vasculitis
20 SLE Female patients will subjected to study of the all vasculitic pattern that may occur.
Vasculitis In SLE
20 SLE female Egyptian patients, among them we are going to study the vasculitic pattern incidence.
Interventions
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Vasculitis In SLE
20 SLE female Egyptian patients, among them we are going to study the vasculitic pattern incidence.
Eligibility Criteria
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Inclusion Criteria
* Ability to give informed consent
* Adult and minor relatives (first and second degree) of individuals Included in IV-G (only for genetic studies)
* Ability of the patient or minor relative s parents to give informed consent
* Affected individuals age greater than or equal to 9 years with no upper age limit
* Healthy Volunteers (non-related) age greater than or equal to 18 with no upper age limit
* Healthy Volunteers (first- and second-degree relatives) age greater than or equal to 9 with no upper age limit
* Vascular studies adults only age greater than or equal to 18 with no upper age limit
Exclusion Criteria
* Concomitant medical, surgical or other conditions for which inadequate facilities are available to support their care at NIH.
Inability or unwillingness to comply with follow up requirements (e.g. distance, social, physical limitations)
* Any comorbidity of medical or psychological/psychiatric condition or treatment after reviewing of patients previous or outside medical records, that in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g. Patient requiring urgent and/or acute medical care, surgical or other procedures)
* Unwilling to participate in research studies or to provide research samples or data.
Criteria for exclusion:
\- Any concomitant medical problems or are taking medications which would confound the interpretation of studies they are considered for
* Subjects with a contraindication to MRI scanning will not receive the optional Cardiovascular MRI. These contraindications include subjects with the following devices:
* Central nervous system aneurysm clips unless it is labeled safe or conditional for MRI
* Implanted neural stimulator (e.g.TENS-Unit) unless it is labeled safe or conditional for MRI
* Implanted cardiac pacemaker or defibrillator
* Cochlearor any type of ear implant unless it is labeled safe or conditional for MRI
* Ocular foreign body (e.g. metal shavings)
* Implanted Insulin pump or drug infusion device unless it is labeled safe or conditional for MRI
* Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI
* Subjects with renal excretory dysfunction, estimated glomerular filtration rate \< 60 mL/min/1.73m(2) using the CKD-EPI equation or equivalent (using the CRIS-calculated eGFR to define the threshold) and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but will not be exposed to the cardiac CT angiography, or gadolinium-based contrast agents.
* Any clinical instability precluding subject from getting MRI as determined by the enrolling clinician.
* Pregnant or lactating women will be excluded from vascular studies.
* Healthy controls with known history of coronary artery disease, peripheral vascular disease or atherosclerosis.
* Individuals younger than 18 years old will be excluded given the radiation exposure as well as the lack of proper validation for the proposed vascular function studies.
22 Years
45 Years
FEMALE
Yes
Sponsors
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Tabarak New Cairo Hospital (TNCH)
OTHER
Responsible Party
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Prof. Dr. /Tayseer Abdulaal
Prof. Dr.
Locations
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Tabarak New Cairo Hospital
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Tayseer A Abdulaal, M.D.
Role: primary
Other Identifiers
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SLE Tabarak 01
Identifier Type: -
Identifier Source: org_study_id