NCT05342285

Brief 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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

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

March 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 30, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

March 21, 2022

Last Update Submit

July 18, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    about 1 yrs

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

    about 1 yrs

Study Arms (3)

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

Flow mediated dilationDIAGNOSTIC_TEST

flow mediated dilation in brachial artery

Normal femaleabnormal FMDnormal FMD

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

femals patient whose age from 18 to 45yrs old

You may qualify if:

  • female patient with SLE aged more than 18

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit University

Asyut, Egypt

RECRUITING

Related Publications (2)

  • 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.

    PMID: 15507132BACKGROUND
  • 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.

    PMID: 35228125BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesAtherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Rafaat fathy

    Rafaatfathy@yahoo.com

    PRINCIPAL INVESTIGATOR

Central Study Contacts

lobna ahmed hassan mohamed, resident doctor

CONTACT

Eman mohamed, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

March 21, 2022

First Posted

April 22, 2022

Study Start

July 30, 2022

Primary Completion

December 27, 2022

Study Completion

December 27, 2023

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations