Shear Stress Endothelial/Hemodynamics in Aortic Dissection and Endothelial Shear Stress-biological Profile

Aortic Dissection Clinical Trial

— HADES-BP  

Official title:

Shear Stress Endothelial/Hemodynamics in Aortic Dissection and Endothelial Shear Stress-biological Profile HADES-BP

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05745428
• Other study ID #: 4626
• Status: Active, not recruiting
• Start date: April 10, 2022
• Est. completion date: April 16, 2024

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aortic dissection (AD) is a clinical condition belonging to the broader spectrum of Acute Aortic Syndromes, with high morbidity and mortality and characterised by the sudden formation of a breach within the tonaca intima of the aortic wall, from which the so-called false lumen originates.The most common risk factor for AD is hypertension, present in more than 70% of. Imaging, biomarkers and genetic predisposition are critical in confirming a suspected diagnosis and in determining the appropriate intervention for each patient. Specific features influencing management decisions are the presence of rupture, extent of dissection, origin of true or false lumen vessels and signs of organ ischaemia.

Description:

The aim of this study is to investigate the diagnostic value of circulating biomarkers and in aortic tissue in patients with AD and to assess the prognosis of patients with AD and its complications in relation to the aforementioned markers, integrating biological data with clinical and instrumental data relating to the patient's hospitalisation. The study involves a comparison between two arms, one experimental and the other control (healthy outpatients). A longitudinal evaluation will be carried out on the experimental arm with a follow-up visit (FUp) at 3, 6 and 12 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: April 16, 2024
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• partecipants admitted to our Department of Cardiovascular Sciences with a radiological diagnosis of AD within 14 days of the onset of symptoms;
• healthy outpatient or inpatient controls at our Department with another diagnosis and no evidence of AD, matched for demographic and clinical characteristics

Exclusion Criteria:

• evidence of inflammatory diseases, infectious diseases, neoplasms, immunological or haematological disorders;
• treatment with anti-inflammatory drugs with the exception of low-dose aspirin (75-160 mg);
• age > 85 years;
• advanced chronic kidney disease with glomerular filtration rate (eGFR) estimated by MDRD equation <30 ml/min./1.73 m2; 5) pregnancy;
• dissection with traumatic aetiology;
• failure to sign informed consent;

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Aortic Dissection

Intervention

Other:
• molecular and cellular analyses
sample blood

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of gene expression	Evaluation of gene expression (by RT-qPCR),the analysis of circulating biomarkers smMYO11 (Human Myosin Heavy Chain 11, SmoothMuscle (MYH11) ELISA Kit, My Biosource), Calponin (Human Calponin-1 ELISA Kit, My Biosource) and MMP-9 (Human MMP-9 Quantikine ELISA Kit, R&D System ) will be performed by enzyme immunoassay on suitably preserved serum from AD and CTRL partecipants, in accordance with the manufacturer's instructions.	1 year
Primary	Evaluation of transcriptomics	This study will be perfomed by single-cell analysis with enzyme immunoassay thanks to the peripheral blood sample that was taken from the participant at the time of enrollment	1 year
Primary	Evaluation of protein	This evaluation immunoenzymatic analyses, it's important to analyze altered biomarkers following fluid dynamic alterations applied by controlled mechanical stress to a model of primary cultures of aortic endothelial cells (HAOEC) and peripheral mononuclear cells (PBMC) isolated from enrolled subjects.	1 year
Secondary	Assessment of correlation between circulating biomarkers	Assessment of correlation between circulating biomarkers, clinical data (signs of haemodynamic stability such as blood pressure (BP), heart rate (HR), oxygen saturation (SpO2), signs of organ malperfusion such as neurological signs distal pulses, oligo-anuria or signs of outward rupture such as cardiac tamponade, acute aortic valvular insufficiency, haemothorax, haemoperitoneum), and imaging data (diameter of the ascending aorta =5 5cm, intimal breach size >10mm, diameter of the false lumen >22mm, partial thrombosis of the false lumen, intimal flap concave towards the false lumen, periaortic haematoma, single entry port or localisation of this in the small curvature of the aortic arch)	1 year