NCT06169865

Brief Summary

Rheumatic autoimmune diseases include conditions such as systemic lupus rheumatoid arthritis systemic sclerosis in which connective tissues are frequently targeted. Autoimmune diseases as a group are among the leading causes of death and morbidity in the industrial world and pose an immense socioeconomic burden despite the considerable accumulative burden of these diseases only a small number of multinational registries for a few selected autoimmune diseases have been devised. Numerous autoimmune inflammatory diseases have been associated with various forms of vasculopathy and increase vascular disease risk such as accelerated atherogenesis and thromboembolic events as digital and acral gangrene secondary Raynaud syndrome arterial aneurysm and different cutaneous ulcer. The etiopathogenesis os increased risk of peripheral vascular diseases and presentation in autoimmune diseases is not entirely clear but multiple contibutors have been explored especially in the context of systemic inflammation and disordered thrombogenesis.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

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

Study Start

First participant enrolled

September 10, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2024

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

December 5, 2023

Last Update Submit

December 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • prevalence of peripheral vascular diseases and presentations in patients with autoimmune diseases .

    old and new vascular diseases and presentations in patients with autoimmune diseases

    6 months

Interventions

cross sectional study to explore magnitude of peripheral vascular diseases and presentations in patients with autoimmune diseases in sohag society.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* All ages * Both sexes * Recent or past history of vascular diseases or presentation in any proven autoimmune diseases according to the guidlines.

You may qualify if:

  • all ages
  • Both sexes
  • Recent or past history of vascular diseases or presentation in any proven autoimmune diseases according to the guidlines.

You may not qualify if:

  • patients refuse the study
  • patients do not have established diagnosis of vascular diseases .
  • patients not completely approved to have autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

  • Cooper GS, Bynum ML, Somers EC. Recent insights in the epidemiology of autoimmune diseases: improved prevalence estimates and understanding of clustering of diseases. J Autoimmun. 2009 Nov-Dec;33(3-4):197-207. doi: 10.1016/j.jaut.2009.09.008. Epub 2009 Oct 9.

    PMID: 19819109BACKGROUND
  • Zoller B, Li X, Sundquist J, Sundquist K. Autoimmune diseases and venous thromboembolism: a review of the literature. Am J Cardiovasc Dis. 2012;2(3):171-83. Epub 2012 Jul 25.

    PMID: 22937487BACKGROUND
  • Bashal F. Thrombosis in Rheumatological Diseases. 2021 Jan 6. In: Almoallim H, Cheikh M, editors. Skills in Rheumatology [Internet]. Singapore: Springer; 2021. Chapter 12. Available from http://www.ncbi.nlm.nih.gov/books/NBK585742/

    PMID: 36315801BACKGROUND
  • Pyrpasopoulou A, Chatzimichailidou S, Aslanidis S. Vascular disease in systemic lupus erythematosus. Autoimmune Dis. 2012;2012:876456. doi: 10.1155/2012/876456. Epub 2012 Aug 22.

    PMID: 22957213BACKGROUND

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Cross-Sectional Studies

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

hosam A Mohamed, resident

CONTACT

Ahmed s Abd Alfatah, assistant professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
resident at vascular surgery department

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 14, 2023

Study Start

September 10, 2023

Primary Completion

May 10, 2024

Study Completion

May 10, 2024

Last Updated

December 14, 2023

Record last verified: 2023-12

Locations