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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

lobna ahmed hassan mohamed, resident doctor contact

01063919340

lolo0559@gmail.com

Eman mohamed, doctor contact

01007179120

Emanmibrahem@gmail.com

Egypt1 site, 1 recruiting
  • Assuit University

    Asyut

    lobna ahmed

    eman ibrahem

    Recruiting

Other trials in Egypt

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.

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 groups in NCT05342285
Study groupRoleWhat they receive
normal FMDSLE femals patientd with normal flow mediated whose ages from 18 to 45yrs
Receives: Diagnostic Test: Flow mediated dilation
abnormal FMDSLE femals with abnormal flow mediated dikation ages between 18 to 45yrs old
Receives: Diagnostic Test: Flow mediated dilation
Normal femalenormal 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.

  1. 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

  2. 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.

  1. First posted22 Apr 2022
  2. Study start30 Jul 2022 (estimated)
  3. Primary completion27 Dec 2022 (estimated)
  4. Study completion27 Dec 2023 (estimated)

Resources

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)
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 15507132
  • Crawley 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

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.

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