SLENCT05479071
Relation of Antibodies Against Oxidized Low Density Lipoproteins to Disease Activity and Cardiovascular Affection in Systemic Lupus.
An observational study of SLE, run by Assiut University.
Trial summary
The aim of this study is to correlate the autoantibody against oxidized LDL with disease activity and cardiovascular affection in patients with SLE. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- SLE
- What is being tested?
- Blood test
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Oct 2023
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 1. Patients aged ≥ 18 years. 2. Patients fulfilling the American College of Rheumatology (ACE) criteria for SLE (Aringer et al., 2019).
- 3. Patients diagnosed with SLE and without cardiovascular disease (CVD) impairment before the diagnosis of SLE was established.
Who cannot join
- Patients aged less than18 years.
- Patients not fulfilling the American College of Rheumatology (ACE) criteria for SLE (Aringer et al., 2019).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Relation of Antibodies Against Oxidized Low Density Lipoproteins to Disease Activit y and Cardiovascular Affection in Systemic Lupus.
The aim of this study is to correlate the autoantibody against oxidized LDL with disease activity and cardiovascular affection in patients with SLE.
Read the detailed description
Systemic lupus erythematosus (SLE) is an autoimmune inflammatory disease affecting mainly women of fertile age. It is characterized by hyperactivity of B-cells and by overproduction of autoantibodies without organ specificity, many of which contribute to the formation of immunocomplexes. Their deposition in tissues and blood vessels results in inflammatory organ impairment (Khairy et al., 2017). As for the laboratory findings in SLE, production of autoantibodies without organ specificity aimed at nuclear, cytoplasmic, and surface antigens of the patient's body is typical. The most common SLE manifestations include involvement of skin, joints, cardiovascular system, lungs, renal glomeruli, central nervous system or hematopoiesis.
SLE can result in failure of the involved organs, severe forms of SLE thus bein gassociated with significant mortality (Pashnina et al., 2021).
Cardiovascular involvement is associated with increased morbidity and mortality of SLE patients. The most common SLE-related cardiovascular events are myocardial infarctions (MIs), cerebrovascular events, thromboembolic events (TEs), heart failure, and sudden death.
Cardiovascular events are proportionally higher in SLE compared to general populations of comparable age and sex (Ramirez et al., 2020). The pathogenic mechanisms of different cardiac diseases in SLE are still incompletely understood. Traditional risk factors for Cardiovascular affection, such as older age, high blood pressure (BP), high cholesterol and triglycerides, smoking, obesity, diabetes mellitus, and - last but not least - SLE therapy all play a critical role. These factors alone cannot adequately explain the increased incidence of cardiovascular disease commonly reported in patients with SLE. Metabolic syndrome was considered a remarkable risk factor for the development of subclinical atherosclerosis and increased carotid intima-media thickness The non-traditional biomarkers included both leptin and homocysteine, where leptin acts on the immune system as aproinflammatory cytokine. It promotes the proliferation and activation of T lymphocytes and induces production of Th1 cytokines. Homocysteinelevels have been identified as a predictor of atherosclerosis in patients with SLE, in whom high levels may be predictive levels of coronary calcification, platelet progression and increased IMT (Khairy et al., 2017).
Specific antibodies cause oxidation of low density lipoprotein (LDL) particles, thus accentuating their atherogenic effect, or exert a negative influence on the character of physiologically protective High density lipoprotein (HDL) particles. Endothelial dysfunction within the vascular system ensues, increasing its vulnerability, affinity to lipoproteins and activity of enzymes accelerating the development of atherosclerosis (Li et al., 2020).
LDLs are transported into artery walls, where they become trapped and bound in the extracellular matrix of the subendothelial space. These trapped LDLs are then seeded with reactive oxygen species produced by nearby artery wall cells, resulting in the formation of proinflammatory Oxidized LDL (OxLDL). oxLDL plays an important role in atherogenesisand may contribute to the immune activation and inflammation present in the atherosclerotic lesions, because it has chemotactic, immune-stimulatory, and toxic properties and is taken up by macrophages and other cells in the atherosclerotic plaque, which develop into foam cells. Epitopes characteristic of oxidized LDL can be found in atherosclerotic lesions by immunocytochemical techniques and atherosclerotic lesions contain immunoglobulins that recognize oxLDL (Ammar et al., 2021).
- Conditions
- SLE
- Being tested
- Blood test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDiagnostic test
Screening of antibodies against LDL
| Study group | Role | What they receive |
|---|---|---|
| SLE patients WITH cardiovascular disease | Relation of antibodies against LDL to disease activity in pt with cardiovascular disease Receives: Diagnostic Test: Blood test | |
| SLE Patients without cardiovascular disease | Relation of antibodies against LDL to disease activity in pt without cardiovascular disease Receives: Diagnostic Test: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SLEStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HADDEEL AHMED MOHMED SAYED AHMED, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479071
- Sponsor's protocol ID
- SLE
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10193434Wu 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.
PubMed 10192509Kurien 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.
PubMed 18625446Tektonidou 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.
PubMed 35247655Tso 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.
PubMed 19037607
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Antibodies Against Oxidized Low Density Lipoproteins to Disease Activit y and Cardiovascular Affection in Systemic Lupus.
- ClinicalTrials.gov ID
- NCT05479071
- Acronym / sponsor ID
- SLE
- Conditions
- SLE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to correlate the autoantibody against oxidized LDL with disease activity and cardiovascular affection in patients with SLE.
Detailed description
Systemic lupus erythematosus (SLE) is an autoimmune inflammatory disease affecting mainly women of fertile age. It is characterized by hyperactivity of B-cells and by overproduction of autoantibodies without organ specificity, many of which contribute to the formation of immunocomplexes. Their deposition in tissues and blood vessels results in inflammatory organ impairment (Khairy et al., 2017). As for the laboratory findings in SLE, production of autoantibodies without organ specificity aimed at nuclear, cytoplasmic, and surface antigens of the patient's body is typical. The most common SLE manifestations include involvement of skin, joints, cardiovascular system, lungs, renal glomeruli, central nervous system or hematopoiesis.
SLE can result in failure of the involved organs, severe forms of SLE thus bein gassociated with significant mortality (Pashnina et al., 2021).
Cardiovascular involvement is associated with increased morbidity and mortality of SLE patients. The most common SLE-related cardiovascular events are myocardial infarctions (MIs), cerebrovascular events, thromboembolic events (TEs), heart failure, and sudden death.
Cardiovascular events are proportionally higher in SLE compared to general populations of comparable age and sex (Ramirez et al., 2020). The pathogenic mechanisms of different cardiac diseases in SLE are still incompletely understood. Traditional risk factors for Cardiovascular affection, such as older age, high blood pressure (BP), high cholesterol and triglycerides, smoking, obesity, diabetes mellitus, and - last but not least - SLE therapy all play a critical role. These factors alone cannot adequately explain the increased incidence of cardiovascular disease commonly reported in patients with SLE. Metabolic syndrome was considered a remarkable risk factor for the development of subclinical atherosclerosis and increased carotid intima-media thickness The non-traditional biomarkers included both leptin and homocysteine, where leptin acts on the immune system as aproinflammatory cytokine. It promotes the proliferation and activation of T lymphocytes and induces production of Th1 cytokines. Homocysteinelevels have been identified as a predictor of atherosclerosis in patients with SLE, in whom high levels may be predictive levels of coronary calcification, platelet progression and increased IMT (Khairy et al., 2017).
Specific antibodies cause oxidation of low density lipoprotein (LDL) particles, thus accentuating their atherogenic effect, or exert a negative influence on the character of physiologically protective High density lipoprotein (HDL) particles. Endothelial dysfunction within the vascular system ensues, increasing its vulnerability, affinity to lipoproteins and activity of enzymes accelerating the development of atherosclerosis (Li et al., 2020).
LDLs are transported into artery walls, where they become trapped and bound in the extracellular matrix of the subendothelial space. These trapped LDLs are then seeded with reactive oxygen species produced by nearby artery wall cells, resulting in the formation of proinflammatory Oxidized LDL (OxLDL). oxLDL plays an important role in atherogenesisand may contribute to the immune activation and inflammation present in the atherosclerotic lesions, because it has chemotactic, immune-stimulatory, and toxic properties and is taken up by macrophages and other cells in the atherosclerotic plaque, which develop into foam cells. Epitopes characteristic of oxidized LDL can be found in atherosclerotic lesions by immunocytochemical techniques and atherosclerotic lesions contain immunoglobulins that recognize oxLDL (Ammar et al., 2021).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLE patients WITH cardiovascular disease | – | Diagnostic Test: Blood testRelation of antibodies against LDL to disease activity in pt with cardiovascular disease |
| SLE Patients without cardiovascular disease | – | Diagnostic Test: Blood testRelation of antibodies against LDL to disease activity in pt without cardiovascular disease |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 1. Patients aged ≥ 18 years. 2. Patients fulfilling the American College of Rheumatology (ACE) criteria for SLE (Aringer et al., 2019).
- 3. Patients diagnosed with SLE and without cardiovascular disease (CVD) impairment before the diagnosis of SLE was established.
Key exclusion criteria (2 listed)
- Patients aged less than18 years.
- Patients not fulfilling the American College of Rheumatology (ACE) criteria for SLE (Aringer et al., 2019).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testScreening of antibodies against LDL | Diagnostic test | SLE Patients without cardiovascular disease, SLE patients WITH cardiovascular disease |
Primary outcome
Checking level of oxidized LDL.
Time frame: Baseline
We expect that oxidized LDL is increasing in patient with SLE and those patients will be at risk for cardiovascular disaeses.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Background: PubMed 10193434Wu 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.
- Results publication: PubMed 10192509Wu 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.
- Results publication: PubMed 18625446Kurien 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.
- Results publication: PubMed 35247655Tektonidou 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.
- Results publication: PubMed 19037607Tso 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of SLE, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haddeel Sayed ahmed, Dr (0020109427161, Drhaddeel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Checking level of oxidized LDL. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05479071, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.