Peripheral Vascular Diseases and Presentation in Patient With Autoimmune DiseasesNCT06169865
Prevalence of Peripheral Vascular Diseases and Presentation in Patients With Autoimmune Diseases
An observational study of Peripheral Vascular Diseases and Presentation in Patient With Autoimmune Diseases, run by Hossam Adly Mohamed at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Vascular Diseases and Presentation in Patient With Autoimmune Diseases
- What is being tested?
- cross sectional study
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2023to 10 May 2024
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: * All ages * Both sexes * Recent or past history of vascular diseases or presentation in any proven autoimmune diseases according to the guidlines.
Who may be able to join
- all ages
- Both sexes
- Recent or past history of vascular diseases or presentation in any proven autoimmune diseases according to the guidlines.
Who cannot join
- patients refuse the study
- patients do not have established diagnosis of vascular diseases .
- patients not completely approved to have autoimmune diseases.
Trial locations and contacts
1 site in 1 country.
Ahmed s Abd Alfatah, assistant professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
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.
Read more
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.
- Being tested
- cross sectional study
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross sectional studyOther
cross sectional study to explore magnitude of peripheral vascular diseases and presentations in patients with autoimmune diseases in sohag society.
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of peripheral vascular diseases and presentations in patients with autoimmune diseases .
old and new vascular diseases and presentations in patients with autoimmune diseases
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start10 Sep 2023
- Primary completion10 May 2024 (estimated)
- Study completion10 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular Diseases and Presentation in Patient With Autoimmune DiseasesStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hossam Adly Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hossam Adly Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169865
- Sponsor's protocol ID
- soh-Med-23-10-03MS
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19819109Zoller 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.
PubMed 22937487Bashal 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/
PubMed 36315801Pyrpasopoulou 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.
PubMed 22957213
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Peripheral Vascular Diseases and Presentation in Patients With Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT06169865
- Acronym / sponsor ID
- soh-Med-23-10-03MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hossam Adly MohamedUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 10 May 2024 (estimated)
- Study completion
- 10 May 2024 (estimated)
- First posted
- 14 Dec 2023 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- * All ages * Both sexes * Recent or past history of vascular diseases or presentation in any proven autoimmune diseases according to the guidlines.
Key inclusion criteria (3 listed)
- all ages
- Both sexes
- Recent or past history of vascular diseases or presentation in any proven autoimmune diseases according to the guidlines.
Key exclusion criteria (3 listed)
- patients refuse the study
- patients do not have established diagnosis of vascular diseases .
- patients not completely approved to have autoimmune diseases.
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 |
|---|---|---|
| cross sectional studycross sectional study to explore magnitude of peripheral vascular diseases and presentations in patients with autoimmune diseases in sohag society. | Other | – |
Primary outcome
prevalence of peripheral vascular diseases and presentations in patients with autoimmune diseases .
Time frame: 6 months
old and new vascular diseases and presentations in patients with autoimmune diseases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Background: PubMed 19819109Cooper 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.
- Background: PubMed 22937487Zoller 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.
- Background: PubMed 36315801Bashal 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/
- Background: PubMed 22957213Pyrpasopoulou 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.
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.
Ahmed s Abd Alfatah, assistant professor contact
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 Peripheral Vascular Diseases and Presentation in Patient With Autoimmune Diseases, run by Hossam Adly Mohamed 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 3 inclusion and 3 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 14 Dec 2023. 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 hosam A Mohamed, resident (01023012244, hosamadly@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of peripheral vascular diseases and presentations in patients with autoimmune diseases . (time frame: 6 months). 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 NCT06169865, which also lists 4 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 14 Dec 2023.