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The Role of Pyroptosis in Chronic Venous Disease

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StatusAktivan, ne regrutuje
Sponzori
University of Catanzaro

Ključne riječi

Sažetak

Enrollment criteria and clinical data collection: following the principles of medical ethics, the development of inclusion and exclusion criteria. Selecting 200 cases of chronic venous disease (CVD) according to the Comprehensive Classification System for Chronic Venous Disorders (CEAP) divided into 6 Clinical stages (C1-C6) (Group A). Selecting 200 healthy participants without CVD (C0) as controls (Group B). Blood samples will be collected from both groups. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated between the two groups and between the subgroups, according to clinical stage, in group A.

Opis

Pyroptosis is a pro-inflammatory form of regulated cell death and is dependent on networks of extracellular fibers (NET,s), on the enzymatic activity of inflammatory proteases that belong to the family of cysteine-dependent aspartate-specific proteases (caspase), and cytokines. The role of inflammation has been previously demonstrated in chronic venous disease (CVD), which is a condition that affects up to 80% of adult population in western countries.

According to the Comprehensive Classification System for Chronic Venous Disorders (CEAP) divided into 6 Clinical stages:

C0: no visible or palpable signs of venous disease. C1: telangiectasies or reticular veins. C2: varicose veins. C3: edema. C4a: pigmentation and eczema. C4b: lipodermatosclerosis and atrophie blanche. C5: healed venous ulcer. C6: active venous ulcer.

The aim of this study is to evaluate the role of pyroptosis in the onset and progression of CVD.

The Investigators will select 200 participants with chronic venous disease (CVD) according to Clinical stage of CEAP (C1-C6 patients) [Group A] . The investigators will also select 200 healthy participants without CVD (C0) as controls [Group B].

Peripheral vein blood samples will be collected from both groups. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated between the two groups and between the subgroups of group A, according to clinical stage.

Datumi

Posljednja provjera: 10/31/2018
Prvo podneseno: 11/11/2018
Predviđena prijava predata: 11/14/2018
Prvo objavljeno: 11/15/2018
Zadnje ažuriranje poslato: 11/14/2018
Posljednje ažuriranje objavljeno: 11/15/2018
Stvarni datum početka studija: 11/11/2018
Procijenjeni datum primarnog završetka: 11/11/2019
Predviđeni datum završetka studije: 11/11/2020

Stanje ili bolest

Inflammation
Veins
Complication
Varicose Veins
Varicose Ulcer

Intervencija / liječenje

Procedure: Peripheral blood draw

Faza

-

Grupe ruku

ArmIntervencija / liječenje
Group A - Participants with CVD
Patients with chronic venous disease (CVD) will undergo peripheral blood draw. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated in blood samples.
Group B - Healthy Participants
Voluntary healthy subjects will undergo peripheral blood draw. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated in blood samples.

Kriteriji prihvatljivosti

Uzrast podoban za studiranje 18 Years To 18 Years
Polovi podobni za studiranjeAll
Metoda uzorkovanjaNon-Probability Sample
Prihvaća zdrave volontereDa
Kriterijumi

Inclusion Criteria:

- Chronic Venous Disease (C1-C6 CEAP classification )

Exclusion Criteria:

- Peripheral artery disease

- Malignant Tumors

- Severe cardiovascular and cerebrovascular disease

- Liver and kidney failure

Ishod

Primarne mjere ishoda

1. Pyroptosis evaluation 1 [2 years]

NETs evaluation to be presented in ng/ml

2. Pyroptosis evaluation 2 [2 years]

Caspase-1 evaluation to be presented in pg/ml

3. Pyroptosis evaluation 3 [2 years]

IL-1 β, IL-4, IL-10, IL-18, and TNF-α evaluation to presented in pg/ml

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