SLENCT05342285
Flow Mediated Dilation in Association With Hyperuricemia
An observational study of SLE and Cardiovascular Diseases, run by Assiut University at 1 site in Egypt.
Trial summary
Assess cardiovascular affection and subclinical atherosclerosis in patients with systemic lupus using the non invasive flow mediated dilation. evaluate the role of uric acid as independent marker of cardiovascular risk in systemic lupus patient Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- SLE, Cardiovascular Diseases, Atherosclerosis
- What is being tested?
- Flow mediated dilation
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2022to 27 Dec 2023
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: femals patient whose age from 18 to 45yrs old
Who may be able to join
- female patient with SLE aged more than 18
Who cannot join
- male patients
- patient with established cardiovascular disease, patients with end stage renal disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assuit University
Asyut
lobna ahmed
eman ibrahem
About this study
Official title: Flow Mediated Dilation in Association With Hyperuricemia as Predictors of Cardiovascular Affection in Patients With Systemic Lupus
Assess cardiovascular affection and subclinical atherosclerosis in patients with systemic lupus using the non invasive flow mediated dilation.
evaluate the role of uric acid as independent marker of cardiovascular risk in systemic lupus patient
Read the detailed description
Systemic lupus erythematosus (SLE) is a complex autoimmune disease that is characterized by multiple end-organ damage and predominantly affects premenopausal women.
Cardiovascular disease is a major cause of morbidity and mortality in systemic lupus erythematosus (SLE) patients. These patients have a higher incidence and an earlier age of onset of ischemic heart disease, carotid atherosclerosis, cerebrovascular stroke, and peripheral vascular Disease. Traditional cardiovascular risk factors, including hypertension, diabetes mellitus, dyslipidemia, and physical inactivity, only account partially for the elevated vascular risk in SLE patients .
Vascular stiffness proven to have better predictive value for fatal and non-fatal cardiovascular events than traditional risk factors in hypertensives and patients with end-stage renal disease or coronary artery disease . Endothelial dysfunction represents the initial step of atherosclerosis and correlates with arterial stiffness which is associated with incident cardiovascular events.
Brachial artery reactivity testing (BART) is used to noninvasively assess responsiveness to reactive hyperemia (flow-mediated dilation [FMD]) and evaluate nitric oxide [NO]-dependent large vessel endothelial function. Reduced FMD reflects impaired endothelial-dependent vasodilation indicative of vascular dysfunction.
Uric acid (UA), the final product of purine degradation, is formed in the liver from precursor proteins and is excreted by the kidneys and intestines. At physiologic concentrations, UA exhibits excellent antioxidant activity; however, when UA exceeds its physiologic levels, it can propagate oxidative damage. Furthermore, chronic elevation of UA constitutes a risk factor for many diseases, as it can promote inflammation and endothelial dysfunction .
Higher prevalence of hyperuricemia in patients with SLE might be owing to several endogenous and exogenous mechanisms such as inflammation, hypertension, and renal involvement, which are prevalent in patients with SLE and have been identified as provoking hyperuricemia through different mechanisms. On the contrary, increased levels of UA can aggravate inflammation, hypertension, and renal disease, thus creating a vicious cycle. Hyperactivity of the xanthine oxidase enzyme in patients with SLE and some of the drugs used in the treatment of SLE are among the other possible reasons for the higher prevalence of hyperuricemia in patients with SLE.
Studies have shown that increases in serum uric acid levels may be tied to an increased risk of cardiovascular disease and mortality. In addition, hyperuricemia has been shown to be associated with endothelial dysfunction as well as the oxidation of lipoproteins within atherosclerotic plaques (contributors to cardiovascular disease risk).
Several studies have highlighted the role of uric acid as an independent biomarker of cardiovascular disease risk. . The link between hyperuricemia and the risk of atherosclerotic cardiovascular and cerebrovascular disease has been well-established. .
In an observational cohort study testing the association between hyperuricemia and coronary artery calcification, the results showed that hyperuricemia is an independent risk factor for sub-clinical atherosclerosis in young adults .
Depending on the microenvironment, uric acid may act as an antioxidant or an oxidant. Under ischemic conditions, xanthine oxidase uses oxygen as an electron acceptor instead of nicotinamide adenine dinucleotide (NAD+) resulting in the formation of superoxide anion and hydrogen peroxide. Oxidants cause endothelial dysfunction by reacting with and removing nitric oxide (NO), which prevents vasodilation of the endothelium. This promotes a pro-inflammatory state that causes endothelial dysfunction and contributes to atherosclerosis and cardiovascular disease .Uric acid can also induce vascular smooth muscle cell proliferation in vitro by producing pro-inflammatory, pro-oxidative, and vasoconstrictive substances. Uric acid stimulates the production of monocyte chemoattractant protein-1 (MCP-1), a chemokine involved in atherosclerosis. Increased production of MCP-1 increases cell proliferation and production of pro-inflammatory mediators. Uric acid stimulates monocyte chemoattractant protein-1 production in vascular smooth muscle cells via mitogen-activated protein kinase and cyclooxygenase-2 .
This study aims to emphasize the role of flow mediated dilation in the detection of endothelial dysfunction in SLE patients and linking it to hyperuricemia as a predictor and contributor of cardiovascular affection which can be useful to guide therapeutic decisions in these patients in the future.
- Conditions
- SLE, Cardiovascular Diseases, Atherosclerosis
- Being tested
- Flow mediated dilation
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow mediated dilationDiagnostic test
flow mediated dilation in brachial artery
| Study group | Role | What they receive |
|---|---|---|
| normal FMD | SLE femals patientd with normal flow mediated whose ages from 18 to 45yrs Receives: Diagnostic Test: Flow mediated dilation | |
| abnormal FMD | SLE femals with abnormal flow mediated dikation ages between 18 to 45yrs old Receives: Diagnostic Test: Flow mediated dilation | |
| Normal female | normal femals whise ages from 18 to 45yrs old Receives: Diagnostic Test: Flow mediated dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of SLE patients who have premature atherosclerosis based on abnormal flow mediated dilation FMD in assiciation with hyperuricemia as predictors of cardiovascular affection in SLE patient
Measured: about 1 yrs
percentage of hyperuricemic patients wh have premature atherosclerosis based on flow mediated dilation
Measured: about 1 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start30 Jul 2022 (estimated)
- Primary completion27 Dec 2022 (estimated)
- Study completion27 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lobna Ahmed Hassan, Assiut University
- Investigators
- Rafaat fathy, Principal investigator, Rafaatfathy@yahoo.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342285
- Sponsor's protocol ID
- FMD
- Status last verified
- Jul 2022
- First submitted
- 21 Mar 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Individual data sharing
- No
Publications
Hayden MR, Tyagi SC. Uric acid: A new look at an old risk marker for cardiovascular disease, metabolic syndrome, and type 2 diabetes mellitus: The urate redox shuttle. Nutr Metab (Lond). 2004 Oct 19;1(1):10. doi: 10.1186/1743-7075-1-10.
PubMed 15507132Crawley WT, Jungels CG, Stenmark KR, Fini MA. U-shaped association of uric acid to overall-cause mortality and its impact on clinical management of hyperuricemia. Redox Biol. 2022 May;51:102271. doi: 10.1016/j.redox.2022.102271. Epub 2022 Feb 17.
PubMed 35228125
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Mediated Dilation in Association With Hyperuricemia as Predictors of Cardiovascular Affection in Patients With Systemic Lupus
- ClinicalTrials.gov ID
- NCT05342285
- Acronym / sponsor ID
- FMD
- Conditions
- SLE, Cardiovascular Diseases, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jul 2022 (estimated)
- Primary completion
- 27 Dec 2022 (estimated)
- Study completion
- 27 Dec 2023 (estimated)
- First posted
- 22 Apr 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.
Assess cardiovascular affection and subclinical atherosclerosis in patients with systemic lupus using the non invasive flow mediated dilation.
evaluate the role of uric acid as independent marker of cardiovascular risk in systemic lupus patient
Detailed description
Systemic lupus erythematosus (SLE) is a complex autoimmune disease that is characterized by multiple end-organ damage and predominantly affects premenopausal women.
Cardiovascular disease is a major cause of morbidity and mortality in systemic lupus erythematosus (SLE) patients. These patients have a higher incidence and an earlier age of onset of ischemic heart disease, carotid atherosclerosis, cerebrovascular stroke, and peripheral vascular Disease. Traditional cardiovascular risk factors, including hypertension, diabetes mellitus, dyslipidemia, and physical inactivity, only account partially for the elevated vascular risk in SLE patients .
Vascular stiffness proven to have better predictive value for fatal and non-fatal cardiovascular events than traditional risk factors in hypertensives and patients with end-stage renal disease or coronary artery disease . Endothelial dysfunction represents the initial step of atherosclerosis and correlates with arterial stiffness which is associated with incident cardiovascular events.
Brachial artery reactivity testing (BART) is used to noninvasively assess responsiveness to reactive hyperemia (flow-mediated dilation [FMD]) and evaluate nitric oxide [NO]-dependent large vessel endothelial function. Reduced FMD reflects impaired endothelial-dependent vasodilation indicative of vascular dysfunction.
Uric acid (UA), the final product of purine degradation, is formed in the liver from precursor proteins and is excreted by the kidneys and intestines. At physiologic concentrations, UA exhibits excellent antioxidant activity; however, when UA exceeds its physiologic levels, it can propagate oxidative damage. Furthermore, chronic elevation of UA constitutes a risk factor for many diseases, as it can promote inflammation and endothelial dysfunction .
Higher prevalence of hyperuricemia in patients with SLE might be owing to several endogenous and exogenous mechanisms such as inflammation, hypertension, and renal involvement, which are prevalent in patients with SLE and have been identified as provoking hyperuricemia through different mechanisms. On the contrary, increased levels of UA can aggravate inflammation, hypertension, and renal disease, thus creating a vicious cycle. Hyperactivity of the xanthine oxidase enzyme in patients with SLE and some of the drugs used in the treatment of SLE are among the other possible reasons for the higher prevalence of hyperuricemia in patients with SLE.
Studies have shown that increases in serum uric acid levels may be tied to an increased risk of cardiovascular disease and mortality. In addition, hyperuricemia has been shown to be associated with endothelial dysfunction as well as the oxidation of lipoproteins within atherosclerotic plaques (contributors to cardiovascular disease risk).
Several studies have highlighted the role of uric acid as an independent biomarker of cardiovascular disease risk. . The link between hyperuricemia and the risk of atherosclerotic cardiovascular and cerebrovascular disease has been well-established. .
In an observational cohort study testing the association between hyperuricemia and coronary artery calcification, the results showed that hyperuricemia is an independent risk factor for sub-clinical atherosclerosis in young adults .
Depending on the microenvironment, uric acid may act as an antioxidant or an oxidant. Under ischemic conditions, xanthine oxidase uses oxygen as an electron acceptor instead of nicotinamide adenine dinucleotide (NAD+) resulting in the formation of superoxide anion and hydrogen peroxide. Oxidants cause endothelial dysfunction by reacting with and removing nitric oxide (NO), which prevents vasodilation of the endothelium. This promotes a pro-inflammatory state that causes endothelial dysfunction and contributes to atherosclerosis and cardiovascular disease .Uric acid can also induce vascular smooth muscle cell proliferation in vitro by producing pro-inflammatory, pro-oxidative, and vasoconstrictive substances. Uric acid stimulates the production of monocyte chemoattractant protein-1 (MCP-1), a chemokine involved in atherosclerosis. Increased production of MCP-1 increases cell proliferation and production of pro-inflammatory mediators. Uric acid stimulates monocyte chemoattractant protein-1 production in vascular smooth muscle cells via mitogen-activated protein kinase and cyclooxygenase-2 .
This study aims to emphasize the role of flow mediated dilation in the detection of endothelial dysfunction in SLE patients and linking it to hyperuricemia as a predictor and contributor of cardiovascular affection which can be useful to guide therapeutic decisions in these patients in the future.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal FMD | – | Diagnostic Test: Flow mediated dilationSLE femals patientd with normal flow mediated whose ages from 18 to 45yrs |
| abnormal FMD | – | Diagnostic Test: Flow mediated dilationSLE femals with abnormal flow mediated dikation ages between 18 to 45yrs old |
| Normal female | – | Diagnostic Test: Flow mediated dilationnormal femals whise ages from 18 to 45yrs old |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- femals patient whose age from 18 to 45yrs old
Key inclusion criteria (1 listed)
- female patient with SLE aged more than 18
Key exclusion criteria (2 listed)
- male patients
- patient with established cardiovascular disease, patients with end stage renal disease
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 |
|---|---|---|
| Flow mediated dilationflow mediated dilation in brachial artery | Diagnostic test | Normal female, abnormal FMD, normal FMD |
Primary outcome
percentage of SLE patients who have premature atherosclerosis based on abnormal flow mediated dilation FMD in assiciation with hyperuricemia as predictors of cardiovascular affection in SLE patient
Time frame: about 1 yrs
percentage of hyperuricemic patients wh have premature atherosclerosis based on flow mediated dilation
Time frame: about 1 yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 15507132Hayden MR, Tyagi SC. Uric acid: A new look at an old risk marker for cardiovascular disease, metabolic syndrome, and type 2 diabetes mellitus: The urate redox shuttle. Nutr Metab (Lond). 2004 Oct 19;1(1):10. doi: 10.1186/1743-7075-1-10.
- Background: PubMed 35228125Crawley WT, Jungels CG, Stenmark KR, Fini MA. U-shaped association of uric acid to overall-cause mortality and its impact on clinical management of hyperuricemia. Redox Biol. 2022 May;51:102271. doi: 10.1016/j.redox.2022.102271. Epub 2022 Feb 17.
- 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.
Rafaat fathy principal investigator
Rafaatfathy@yahoo.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SLE and Cardiovascular Diseases, run by Assiut University at 1 site in Egypt.
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 1 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 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 lobna ahmed hassan mohamed, resident doctor (01063919340, lolo0559@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of SLE patients who have premature atherosclerosis based on abnormal flow mediated dilation FMD in assiciation with hyperuricemia as predictors of cardiovascular affection in SLE patient (time frame: about 1 yrs). The study lists 2 primary outcomes in all. 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 NCT05342285, which also lists 2 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 20 Jul 2022.