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Status unknownNCT05342285Updated Jul 20, 2022

Flow Mediated Dilation in Association With Hyperuricemia

An observational study in SLE, Cardiovascular Diseases and Atherosclerosis, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years to 45 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • SLE
  • Cardiovascular Diseases
  • Atherosclerosis
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 60 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

femals patient whose age from 18 to 45yrs old

Inclusion criteria

  • female patient with SLE aged more than 18

Exclusion criteria

Exclusion Criteria:

  • male patients
  • patient with established cardiovascular disease, patients with end stage renal disease
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • normal FMD

    SLE femals patientd with normal flow mediated whose ages from 18 to 45yrs

    Diagnostic Test: Flow mediated dilation

  • abnormal FMD

    SLE femals with abnormal flow mediated dikation ages between 18 to 45yrs old

    Diagnostic Test: Flow mediated dilation

  • Normal female

    normal femals whise ages from 18 to 45yrs old

    Diagnostic Test: Flow mediated dilation

Interventions

  • Diagnostic testFlow mediated dilation

    flow mediated dilation in brachial artery

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What researchers measure

Primary outcomes

  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

    Time frame: about 1 yrs

  2. percentage of hyperuricemic patients wh have premature atherosclerosis based on flow mediated dilation

    Time frame: about 1 yrs

07

Study locations

1 of 1 sites recruiting
  • Assuit University
    Assiut, Egypt
    • lobna ahmed · Contact
    • eman ibrahem · Contact
    Recruiting
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References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05342285
Lead sponsor
Assiut University
Responsible party
Lobna Ahmed Hassan (principle investigator, Assiut University) — Principal investigator
First posted
Apr 22, 2022
Start date
Jul 30, 2022 (estimated)
Primary completion
Dec 27, 2022 (estimated)
Completion
Dec 27, 2023 (estimated)
Last update
Jul 20, 2022

Study contacts

lobna ahmed hassan mohamed, resident doctor
Contact
lolo0559@gmail.com
01063919340
Eman mohamed, doctor
Contact
Emanmibrahem@gmail.com
01007179120
Rafaat fathy
principal investigator · Rafaatfathy@yahoo.com
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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