NCT05479071

Brief Summary

The aim of this study is to correlate the autoantibody against oxidized LDL with disease activity and cardiovascular affection in patients with SLE.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

July 27, 2022

Last Update Submit

July 27, 2022

Conditions

SLE

Outcome Measures

Primary Outcomes (1)

  • Checking level of oxidized LDL.

    We expect that oxidized LDL is increasing in patient with SLE and those patients will be at risk for cardiovascular disaeses.

    Baseline

Study Arms (2)

SLE patients WITH cardiovascular disease

Relation of antibodies against LDL to disease activity in pt with cardiovascular disease

Diagnostic Test: Blood test

SLE Patients without cardiovascular disease

Relation of antibodies against LDL to disease activity in pt without cardiovascular disease

Diagnostic Test: Blood test

Interventions

Blood testDIAGNOSTIC_TEST

Screening of antibodies against LDL

SLE Patients without cardiovascular diseaseSLE patients WITH cardiovascular disease

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients in our study will be subjected to: * History taking including: age, sex, special habit, BMI, comorbid diseases. * Pharmacological history. * Abdominal, neurological and locomotor systems examination. * Laboratory tests including: * Current activity of antibodies (antinucleolar antibodies (ANA) -, antinucleosomal antibodies, and anticardiolipin antibodies). * High sensitivity C-reactive protein (hsCRP) * oxidized LDL (oxLDL). * Lipid spectrum analysis comprised: the total cholesterol, LDL- cholesterol concentration, and HDL-cholesterol concentration. * ECG, and Echo. * Carotid intima- media thickness by carotid doppler.

You may qualify if:

  • \- 1. Patients aged ≥ 18 years. 2. Patients fulfilling the American College of Rheumatology (ACE) criteria for SLE (Aringer et al., 2019).
  • \. Patients diagnosed with SLE and without cardiovascular disease (CVD) impairment before the diagnosis of SLE was established.

You may not qualify if:

  • Patients aged less than18 years.
  • Patients not fulfilling the American College of Rheumatology (ACE) criteria for SLE (Aringer et al., 2019).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Wu R, Svenungsson E, Gunnarsson I, Haegerstrand-Gillis C, Andersson B, Lundberg I, Elinder LS, Frostegard J. Antibodies to adult human endothelial cells cross-react with oxidized low-density lipoprotein and beta 2-glycoprotein I (beta 2-GPI) in systemic lupus erythematosus. Clin Exp Immunol. 1999 Mar;115(3):561-6. doi: 10.1046/j.1365-2249.1999.00830.x.

    PMID: 10193434BACKGROUND

  • Wu R, Svenungsson E, Gunnarsson I, Andersson B, Lundberg I, Schafer Elinder L, Frostegard J. Antibodies against lysophosphatidylcholine and oxidized LDL in patients with SLE. Lupus. 1999;8(2):142-50. doi: 10.1191/096120399678847434.

    PMID: 10192509RESULT

  • Kurien BT, Scofield RH. Autoimmunity and oxidatively modified autoantigens. Autoimmun Rev. 2008 Jul;7(7):567-73. doi: 10.1016/j.autrev.2008.04.019. Epub 2008 May 27.

    PMID: 18625446RESULT

  • Tektonidou MG. Cardiovascular disease risk in antiphospholipid syndrome: Thrombo-inflammation and atherothrombosis. J Autoimmun. 2022 Apr;128:102813. doi: 10.1016/j.jaut.2022.102813. Epub 2022 Mar 2.

    PMID: 35247655RESULT

  • Tso TK, Huang WN. Elevation of fasting insulin and its association with cardiovascular disease risk in women with systemic lupus erythematosus. Rheumatol Int. 2009 May;29(7):735-42. doi: 10.1007/s00296-008-0781-7. Epub 2008 Nov 27.

    PMID: 19037607RESULT

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Haddeel Sayed ahmed, Dr

CONTACT

0020109427161Drhaddeel@gmail.com

Osama Ibraheem, Pro

CONTACT

00201006372498Oibrahiem@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 27, 2022

First Posted

July 29, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share