NON CANONICAL ACTIVATION OF BOOD COAGULATION

NCT07242521 | Not Yet Recruiting

• 1 other identifier: 7843
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cardiovascular diseases (CVD) are the major cause of mortality and morbidity worldwide and most of them are characterized by enhanced generation of active -thrombin (T) from the inactive Prothrombin zymogen (ProT), a reaction catalysed by factor Xa. CVD may be idiopathic, but also appear as the expression of thrombotic complications occurring with variable incidence and severity in different (apparently unrelated) diseases, such as for instance Type-2 Diabetes (T2D) , Chronic Kidney Disease (CKD), Inflammatory Bowel Disease (IBD) , Cancer , rheumatoid (RA) arthritis , autoimmune diseases such as the AntiPhospholipid Syndrome (APS), bacterial and viral infectious diseases, and amyloid-related diseases such as Alzheimer's disease, IgG light-chain amyloidosis and human transthyretin (hTTR) Senile Systemic Amyloidosis.This Project aims at combining different and complementary expertise with the general purpose of identifying new pathogenetic mechanisms for CVD and explored the possibility to devise novel and more effective therapeutic strategies.

Conditions

Oxidative Stress; vonWillebrand Disease; Carotid Artery Stenosis Symptomatic; Carotid Artery Stenosis Asymptomatic

Outcome Measures

Primary Outcomes (1)

• Determination of total plasma protein carbonyls and VWF content and distribution of VWF multimers in T2D plasma samples.

  Determination of total plasma protein carbonyls and VWF content and distribution of VWF multimers in T2D plasma samples. The total carbonyl content of plasma samples will be measured as stable markers of oxidative modification of proteins, using the ELISA Kit. VWF antigen (VWF:Ag), VWF as collagen binding activity (VWF:CBA), coagulation FVIII levels will be determined according to standard clinical assays.

  six months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with carotid artery stenosis (CAS); asymptomatic form of CAS (Cohort A) and symptomatic CAS (Cohort B). In each cohort, T2DM and not diabetic patients will be enrolled with a 1:1 ratio.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Central Study Contacts

Tinelli Giovanni Prof. Giovanni Tinelli

CONTACT

+39 3474864020; giovanni.tinelli@unicatt..it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Giovanni Tinelli

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: February 6, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-10