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SLE Vasculitis In Egyptian Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386889
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. /Tayseer Abdulaal, Tabarak New Cairo Hospital (TNCH)

Brief Summary:
Systemic lupus erythematosus (SLE) is a complex heterogeneous autoimmune disease with a wide variety of clinical and serological manifestations that may affect any organ. Vasculitis prevalence in SLE is reported to be between 11% and 36%.

Condition or disease Intervention/treatment Phase
Vasculitis Lupus Other: Vasculitis In SLE Not Applicable

Detailed Description:
Systemic lupus erythematosus (SLE) is a complex heterogeneous autoimmune disease with a wide variety of clinical and serological manifestations that may affect any organ. Vasculitis prevalence in SLE is reported to be between 11% and 36%. A diverse clinical spectrum, due to inflammatory involvement of vessels of all sizes, is present. Even though cutaneous lesions, representing small vessel involvement, are the most frequent, medium and large vessel vasculitis may present with visceral affection, with life-threatening manifestations such as mesenteric vasculitis, pulmonary hemorrhage, or mononeuritis multiplex, with detrimental consequences. Early recognition and an appropriate treatment are crucial. Recent studies have shown that vasculitis in patients with SLE may present different clinical forms based on the organ involved and the size of the affected vessel. It is noteworthy that the episodes of vasculitis are not always accompanied by high disease activity. Recent articles on this topic have focused on new treatments for the control of vascular disease, such as biological therapies such as Rituximab and Belimumab, among others.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: SLE Vasculitis Incidence In Female Egyptian Patients
Estimated Study Start Date : July 25, 2020
Estimated Primary Completion Date : November 25, 2020
Estimated Study Completion Date : December 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vasculitis

Arm Intervention/treatment
SLE Vasculitis
20 SLE Female patients will subjected to study of the all vasculitic pattern that may occur.
Other: Vasculitis In SLE
20 SLE female Egyptian patients, among them we are going to study the vasculitic pattern incidence.




Primary Outcome Measures :
  1. SLE Vasculitis [ Time Frame: 6 months ]
    Incidence of vasculitic pattern



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • LE or suspected SLE established by ACR 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 problems which would confound the interpretation of studies gathered by this protocol. Included in this is the presence of HIV in the blood, active malignancies, or other significant medical conditions that may interferes with interpretation of some lupus studies.
  • 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

EXCLUSION CRITERIA FOR VASCULAR STUDIES ONLY, FOR SLE AND HEALTHY CONTROLS:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386889


Contacts
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Contact: Tayseer A Abdulaal, M.D. +201223407675 tayseer@mail.com

Locations
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Egypt
Tabarak New Cairo Hospital Recruiting
Cairo, Egypt, 11613
Contact: Tayseer A Abdulaal, M.D.    +201223407675    tayseer@mail.com   
Sponsors and Collaborators
Tabarak New Cairo Hospital (TNCH)
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Responsible Party: Prof. Dr. /Tayseer Abdulaal, Prof. Dr., Tabarak New Cairo Hospital (TNCH)
ClinicalTrials.gov Identifier: NCT04386889    
Other Study ID Numbers: SLE Tabarak 01
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Vasculitis
Vascular Diseases
Cardiovascular Diseases